<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830190</url>
  </required_header>
  <id_info>
    <org_study_id>NICE-PD</org_study_id>
    <nct_id>NCT03830190</nct_id>
  </id_info>
  <brief_title>Cost-effectiveness of Nursing Interventions for Patients With PD</brief_title>
  <acronym>NICE-PD</acronym>
  <official_title>Cost-Effectiveness of Specialized Nursing Interventions for Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zambon SpA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Current guidelines recommend that every person with Parkinson's disease (PD)&#xD;
      should have access to Parkinson's Disease Nurse Specialist (PDNS) care. Thus, hospitals&#xD;
      increasingly offer PDNS care to their patients with PD. However, there is currently little&#xD;
      scientific evidence on the cost-effectiveness of PDNS care. Consequently, many hospitals lack&#xD;
      the nursing capacity to offer PDNS care to all patients, which creates unequal access to care&#xD;
      and possibly avoidable disability and costs.&#xD;
&#xD;
      Objective: The investigators aim to study the (cost-)effectiveness of specialized nursing&#xD;
      care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages.&#xD;
      To gain more insight into the used interventions and their effects, a subgroup analysis will&#xD;
      be performed based on disease duration (diagnosis made &lt;5, 5-10, or &gt;10 years ago).&#xD;
&#xD;
      Methods: The investigators will perform an 18-month, single-blind, randomized controlled&#xD;
      clinical trial in eight community hospitals in the Netherlands. A total of 240 people with&#xD;
      idiopathic PD that have not been treated by a PDNS over the past two years will be included,&#xD;
      independent of disease severity or duration. In each hospital, 30 patients will randomly be&#xD;
      allocated in a 1:1 ratio to either PDNS care according to the Dutch Guideline on PDNS care or&#xD;
      no nursing intervention (continuing usual care). For the allocation of participants, a&#xD;
      computer-generated list of random numbers will be used. The co-primary outcome measures are&#xD;
      Quality of Life (QoL) and motor symptoms. Secondary outcomes include PD symptoms, mobility,&#xD;
      non-motor symptoms, health-related quality of life, experienced quality of care,&#xD;
      self-management, medication adherence, caregiver quality of life, coping skills and caregiver&#xD;
      burden. Data will be collected after 12 months and 18 months. A healthcare utilization and&#xD;
      productivity loss questionnaire will be completed every 3 months by both the patient and the&#xD;
      caregiver.&#xD;
&#xD;
      Hypothesis: The investigators hypothesize that, by offering more patients access to PDNS&#xD;
      care, QoL will increase with equal healthcare costs. Increasing direct medical costs (for&#xD;
      nurse staffing) will be offset by a reduced number of consultations with the general&#xD;
      practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care&#xD;
      is needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background The Parkinson's Disease Nurse Specialist (PDNS) can fulfill a pivotal role in&#xD;
           the multidisciplinary team of people with PD. The PDNS was introduced in 1989 in the&#xD;
           United Kingdom to bridge the gap between medical management and the unique personal&#xD;
           needs of patients. To obtain greater uniformity in care delivery by a PDNS and to&#xD;
           facilitate the efficacy of nursing care in PD, the Dutch Guideline 'Nursing care in&#xD;
           Parkinson's disease' was published in 2016. The main roles of the PDNS are clearly&#xD;
           described in the Guideline, and include 1) providing information, education and&#xD;
           instruction; 2) supporting the patient and caregiver in the promotion of&#xD;
           self-management; 3) supporting psychosocial care questions; 4) prevention; 5)&#xD;
           specialized diagnostic strategies and therapeutic nursing interventions; and 6)&#xD;
           multidisciplinary collaboration.&#xD;
&#xD;
           Based on expert opinion from healthcare professionals, the Dutch guideline advises that&#xD;
           every person with PD could benefit from PDNS care, including those in early-stage&#xD;
           disease where delivery of information, education about medication compliance and support&#xD;
           in self-management are critical. So far, only three studies have evaluated PDNS care and&#xD;
           they have found inconsistent results. Overall, they indicate that PDNS care may improve&#xD;
           patient wellbeing, physical functioning and general health status and reduce anxiety and&#xD;
           depression, but definite conclusions could not be drawn. Moreover, there is little&#xD;
           evidence that shows that quality of life actually improves with PDNS care and to date,&#xD;
           no studies have been performed that evaluated the cost-effectiveness of PDNS care.&#xD;
&#xD;
           Currently, most hospitals in The Netherlands offer PDNS care, since it is advised in the&#xD;
           Dutch Multidisciplinary Guideline. However many centers still lack the nursing capacity&#xD;
           to offer PDNS care to all patients because the scientific evidence is inconclusive. This&#xD;
           situation creates an undesirable inequality in access to care and presumably leads to&#xD;
           avoidable disability and costs (e.g. from early admissions to nursing homes or crisis&#xD;
           admissions to the hospital). Therefore, the investigators aim to study the&#xD;
           cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS&#xD;
           care for people with PD.&#xD;
&#xD;
        2. Study design The NICE-PD study is an 18-month, single-blind randomized controlled&#xD;
           clinical trial that will be performed in eight community hospitals in the Netherlands. A&#xD;
           total of 240 people with PD will be included (120 in each group) and equally distributed&#xD;
           over the participating hospitals. The investigators have selected hospitals where, due&#xD;
           to lack of sufficient PDNS staff, only a proportion of PD patients currently has access&#xD;
           to PDNS care. This provides the investigators with a unique opportunity to identify&#xD;
           patients who at present have no access to PDNS care, and to randomize them within&#xD;
           hospitals (at the patient level) between PDNS care and no nursing intervention.&#xD;
&#xD;
           Eligible patients will be allocated randomly to either PDNS care or usual care in a 1:1&#xD;
           ratio, using a computer-generated list of random numbers. To ascertain an equal&#xD;
           representation of patients, the investigators will stratify for disease duration&#xD;
           (according to pre-defined subgroups, i.e. disease duration &lt;5 years, 5-10 years and &gt;10&#xD;
           years). The PDNS intervention will be carried out according to the Dutch 'Guideline&#xD;
           Nursing care in PD'. A blinded researcher will perform the clinical assessments at&#xD;
           baseline (t0), after 12 months (t1) and after 18 months (t2). Patients and caregivers&#xD;
           will also be asked to complete a set of questionnaires at t0, t1 and t2. Finally, every&#xD;
           three months patients and their caregivers will complete an online questionnaire about&#xD;
           healthcare utilization, costs and productivity loss.&#xD;
&#xD;
        3. Intervention&#xD;
&#xD;
           The PDNS intervention will be performed according to the Dutch 'Guideline Nursing care&#xD;
           in PD' published in 2015. The intervention is not standardized, but tailored to the&#xD;
           patients' and caregivers' needs. This includes the following:&#xD;
&#xD;
             -  Assessment of individual care needs of people with PD and their caregivers. The&#xD;
                PDNS performs a specific nursing assessment related to the medical, physical,&#xD;
                psychological and social domains.&#xD;
&#xD;
             -  Development of a patient-centered treatment plan that supports the patient and&#xD;
                caregiver in self-management. The PDNS composes a multidisciplinary plan, based on&#xD;
                the results of the individual assessment, and as prioritized by the patient and&#xD;
                caregiver (shared decision making). The treatment plan is developed according to&#xD;
                the national self-management framework.&#xD;
&#xD;
             -  Specific nursing interventions. The intervention varies across disease stages and&#xD;
                is tailored to the specific problems and needs of individual patients and their&#xD;
                caregivers. The Guideline on PDNS care describes general- and specific nursing&#xD;
                interventions. General interventions consist of providing information and&#xD;
                education, disease management (e.g. considering advanced treatment options such as&#xD;
                DBS) and monitoring (e.g. of caregiver burden). Specific nursing interventions are&#xD;
                described for the following areas: mental functions, fatigue, sleep, urogenital&#xD;
                functions, sexuality, medication adherence, orthostatic hypotension, caregiver&#xD;
                burden, coping, mobility, self-management and dietary issues (table 2 provides&#xD;
                examples of such interventions).&#xD;
&#xD;
             -  Collaboration with other healthcare professionals. The PDNS stimulates and supports&#xD;
                multidisciplinary collaboration between healthcare professionals based on the&#xD;
                individual patient-centered treatment plan. The PDNS also plays a pivotal role in&#xD;
                the timely referral to other healthcare professionals.&#xD;
&#xD;
           The PDNS will keep a pre-defined electronic study report according to a structured&#xD;
           format for each PD patient, documenting the individual care needs, present symptoms,&#xD;
           performed interventions and (changes in) the individual care plan. This report will be&#xD;
           started at the initial assessment and updated at every follow-up contact with the&#xD;
           patient, e.g. at the outpatient clinic, during a telephone consultation or at a home&#xD;
           visit. This data will be purposefully collected for a possible process analysis at the&#xD;
           end of the study.&#xD;
&#xD;
           Patients will have regular contact with their PDNS about the progress and realization of&#xD;
           the personal goals, both during face-to-face contacts and by telephone, and sometimes&#xD;
           during additional home visits. The frequency and type of contact will be optimized for&#xD;
           each patient depending on disease stage and individual patient needs. The Guideline on&#xD;
           PDNS care advises that each patient has a minimum of one contact with the PDNS each&#xD;
           year. Currently in the Netherlands, patients are seen on average twice a year by their&#xD;
           PDNS, with an additional two interim telephone consultations per year.&#xD;
&#xD;
           The control group will receive ongoing/ usual care which is otherwise comparable, but&#xD;
           without a nursing intervention. This involves regular consultations with a neurologist&#xD;
           in their own community hospital (typically 2-4 times per year, depending on patient&#xD;
           preferences and health status). In addition, control patients will have no other&#xD;
           restrictions considering any other medical treatments (e.g. by a psychologist or social&#xD;
           worker). Importantly, many important elements of care (including in particular the&#xD;
           treating neurologist) remain comparable between the two intervention arms because of the&#xD;
           randomization at patient level within hospitals.&#xD;
&#xD;
        4. Clinical assessments At baseline, t1 and t2 all patients will visit their own hospital&#xD;
           for the study assessments which are performed by a blinded researcher (PDQ-39,&#xD;
           MDS-UPDRS, and TUG). Furthermore, the patients and their caregivers will complete&#xD;
           additional home questionnaires. In addition, every three months, patients will receive a&#xD;
           questionnaire at home regarding healthcare utilization, costs and productivity loss over&#xD;
           the past three months. Caregivers will complete a cost questionnaire including&#xD;
           healthcare utilization, costs and productivity loss specifically related to caregiver&#xD;
           burden. Patients can choose if they want to fill out digital or paper questionnaires.&#xD;
&#xD;
        5. Data analysis The economic evaluation investigates, alongside the clinical trial, the&#xD;
           value for money of full implementation of the PDNS into PD care from a societal and&#xD;
           healthcare perspective. The investigators will take all relevant costs into account. The&#xD;
           cost-effectiveness timeframe adheres to the clinical study protocol and evaluates&#xD;
           cost-effectiveness up to 18 months after randomization. Cost will be measured using a&#xD;
           healthcare utilization questionnaire (e.g. including medical consultations, hospital&#xD;
           admissions, medication, travel costs, etc.) and a questionnaire measuring productivity&#xD;
           loss while working of both patients and caregivers. Per item of healthcare consumption,&#xD;
           standard cost-prices will be determined using the guideline for performing economic&#xD;
           evaluations. If standardized prices are not available, full cost prices will be&#xD;
           determined using activity based costing. Costs will be analyzed using a mixed model&#xD;
           approach or a general linear model approach with a gamma distribution using a log link&#xD;
           to account for possible skewness of the cost data.&#xD;
&#xD;
           The investigators will use a PD-specific quality of life measure (PDQ-39) and a generic&#xD;
           health-related quality of life scale (EQ5D) to evaluate the quality of the health status&#xD;
           of patients. The potential difference in Quality-Adjusted Life Years (QALYs) measured&#xD;
           with the EQ5D will be analyzed with a regression approach. The investigators will use a&#xD;
           linear mixed model with repeated measurements to test for differences in quality of life&#xD;
           (measured with the PDQ-39) between both groups. The same analysis will be used to&#xD;
           measure differences between groups in the secondary outcome measures. The investigators&#xD;
           will include study center as a random effect and fixed effects for group, time and the&#xD;
           interaction between group and time. Each of the outcomes will be included as dependent&#xD;
           variable. Statistical analyses will be performed based on the intention-to-treat&#xD;
           principle.&#xD;
&#xD;
           Besides the overall cost-effectiveness evaluation, the investigators will perform a&#xD;
           pre-planned subgroup analysis based on disease duration (diagnosis made &lt;5 years, 5-10&#xD;
           years or &gt;10 years ago) to obtain more insight into the nursing interventions used in&#xD;
           each disease stage and the effects of PDNS care in these different groups of patients.&#xD;
           This subgroup analysis will be performed because, for example, for the more severely&#xD;
           affected patients the nursing intervention is expected to become more intensive and&#xD;
           possibly more effective, but also more expensive. When different patterns of this kind&#xD;
           are found, this should be investigated further in future trials that are powered&#xD;
           adequately to address such group differences.&#xD;
&#xD;
        6. Discussion The investigators hypothesize that offering PDNS care will lead to higher&#xD;
           quality of life with equal healthcare costs. Increasing direct medical costs (for nurse&#xD;
           staffing) are expected to be offset by a reduced number of (telephone) consultations&#xD;
           with the general practitioner and neurologist. These short-term goals are the focus of&#xD;
           the present NICE-PD proposal. In addition to the short-term effects, the investigators&#xD;
           also expect long-term benefits, which are out of scope of the present project. Examples&#xD;
           of potential long-term benefits include a reduction in the number of nursing home&#xD;
           admissions and fewer emergency visits to the hospital, which would lead to a substantial&#xD;
           cost reduction.&#xD;
&#xD;
      In conclusion, this study will generate new insights into the cost-effectiveness of&#xD;
      specialized PD nursing interventions for people with PD. If positive results are found, a&#xD;
      large shift in the organization of PD care is needed to warrant equal access to PDNS care for&#xD;
      every person with PD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial with 2 study arms: the intervention group and the control group. Participants are allocated to each arm in a 1:1 ratio.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Due to the type of intervention (Parkinson's disease nurse specialist care), the participant and care provider cannot be masked. The investigator and outcome assessor (conducting the questionnaires) will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-specific health-related quality of life: Parkinson's disease Questionnaire (PDQ-39)</measure>
    <time_frame>Baseline, change from baseline quality of life at 12 months, change from baseline quality of life at 18 months</time_frame>
    <description>Parkinson's disease Questionnaire (PDQ-39). Total score range: 0-100, including 8 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor symptoms</measure>
    <time_frame>Baseline, change from baseline motor symptoms at 12 months, change from baseline motor symptoms at 18 months</time_frame>
    <description>Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III). Total score range: 0-132. A lower score means a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Longitudinal Parkinson's disease symptoms</measure>
    <time_frame>Baseline, change from baseline Parkinson's disease symptoms at 12 months, change from baseline Parkinson's disease symptoms at 18 months</time_frame>
    <description>Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part I, II, IV (MDS-UPDRS part I, II, IV). Total score range: 0-260 (including the MDS-UPDRS part III), including 4 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>Baseline, change from baseline TUG at 12 months, change from baseline TUG at 18 months</time_frame>
    <description>Timed up and Go (TUG). A lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-motor symptoms (anxiety and depression)</measure>
    <time_frame>Baseline, 12 months, 18 months</time_frame>
    <description>Hamilton Anxiety and Depression Scale (HADS). Total score range: 0-21, including 2 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-motor symptoms</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Scales for Outcomes in Parkinson's disease - Autonomic Questionnaire (SCOPA-AUT). Total score range: 0-69, including 6 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life: EuroQoL5D (EQ5D)</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>EuroQoL5D (EQ5D). Summary index with a maximum score of 1, including 5 dimensions. A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general health status with a total score range of 0-100. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experienced quality of and experience with provided healthcare: Consumer Quality Index (CQI)</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Consumer Quality Index (CQI). There is no minimum or maximum score (the measure consists of a number of qualitative and experience questions). Therefore, higher values do not correlate with a better or worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-management</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Patient Activation Measure (PAM13). Total score range: 0-100, including a division in 4 activation levels. A higher score means a higher activation level (= the patient has made most of the necessary behavior changes to manage their disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Morisky Medication Adherence Scale (MMAS). Total score range: 0-8. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life of the caregiver: EuroQoL5D (EQ5D)</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>EuroQoL5D (EQ5D). Summary index with a maximum score of 1, including 5 dimensions. A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general health status with a total score range of 0-100. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver burden</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Zarit Caregiver Burden Index (ZBI). Total score range: 0-88. A lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver quality of life: CarerQol-7D</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>CarerQol-7D. Total score range: 0-14 (weighted sum score: 0-100). A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general well-being with a total score range of 0-10. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skills of proactive coping of the caregiver</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Utrecht Proactive Coping Competence Scale (UPCC). Total score range: 21-84. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical consumption of the patient</measure>
    <time_frame>Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months</time_frame>
    <description>Medical Consumption Questionnaire (MCQ). There is no minimum or maximum score, this scale is a generic instrument for measuring medical costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Productivity loss of the patient</measure>
    <time_frame>Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months</time_frame>
    <description>Productivity Cost Questionnaire (PCQ). There is no minimum or maximum score, this scale is a generic instrument to measure productivity losses related to the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical consumption of the caregiver related to providing care to the patient</measure>
    <time_frame>Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months</time_frame>
    <description>Adjusted version of the Medical Consumption Questionnaire (MCQ). There is no minimum or maximum score, this scale is a generic instrument for measuring medical costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Productivity loss of the caregiver related to providing care to the patient</measure>
    <time_frame>Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months</time_frame>
    <description>Adjusted version of the Productivity Cost Questionnaire (PCQ). There is no minimum or maximum score, this scale is a generic instrument to measure productivity losses related to being a caregiver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nighttime sleep problems and daytime sleepiness</measure>
    <time_frame>Baseline, change from baseline at 12 months, change from baseline at 18 months</time_frame>
    <description>Scales for Outcomes in Parkinson's disease - Sleep Questionnaire (SCOPA-SLEEP). Total score range: 0-33, including 2 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parkinson's disease nurse specialist care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parkinson's disease nurse specialist care</intervention_name>
    <description>Specialized nursing care provided by a Parkinson's disease nurse specialist</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>PDNS care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of idiopathic PD;&#xD;
&#xD;
          -  Sufficient knowledge of the Dutch language to fill out questionnaires;&#xD;
&#xD;
          -  Age 18 years or older at the time of diagnosis;&#xD;
&#xD;
          -  All disease stages, regardless of disease severity or disease duration;&#xD;
&#xD;
          -  Not having received care from a PDNS in the past two years;&#xD;
&#xD;
          -  A score of ≥ 18 on the Mini-Mental State Examination (MMSE13) and ≥ 12 on the Frontal&#xD;
             Assessment Battery (FAB14).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A type of atypical parkinsonism caused by medication (e.g. neuroleptics), a metabolic&#xD;
             disorder (e.g. Wilson's disease), encephalitis or a neurodegenerative disorder (e.g.&#xD;
             multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome).&#xD;
&#xD;
          -  Residing in a nursing home or another type of residential care facility (because the&#xD;
             PDNS is not operational there).&#xD;
&#xD;
          -  Any other medical or psychiatric disorder that, in the opinion of the researcher, may&#xD;
             compromise participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bastiaan R Bloem, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, Radboudumc, Nijmegen, The Netherlands.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nienke M de Vries, PhD</last_name>
    <phone>003124-3615213</phone>
    <email>nienke.devries-farrouh@radboudumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Danique LM Radder, MD</last_name>
    <phone>003124-3655345</phone>
    <email>danique.radder@radboudumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Radboud University Medical Center, Department of Neurology</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nienke M de Vries, PhD</last_name>
      <phone>003124-3615213</phone>
      <email>nienke.devries-farrouh@radboudumc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Danique LM Radder, MD</last_name>
      <phone>003124-3655345</phone>
      <email>danique.radder@radboudumc.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Bastiaan R Bloem, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nienke M de Vries, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Danique LM Radder, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Herma H Lennaerts, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Linda ter Brake, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marten Munneke, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://parkinsonnet.info/media/2733747/7994_multidisciplin_rl_parkinson_c_-_2011.pdf</url>
    <description>Dutch Multidisciplinary Guideline for Parkinson's disease</description>
  </link>
  <reference>
    <citation>Lennaerts H, Groot M, Rood B, Gilissen K, Tulp H, van Wensen E, Munneke M, van Laar T, Bloem BR. A Guideline for Parkinson's Disease Nurse Specialists, with Recommendations for Clinical Practice. J Parkinsons Dis. 2017;7(4):749-754. doi: 10.3233/JPD-171195.</citation>
    <PMID>28800338</PMID>
  </reference>
  <reference>
    <citation>Jahanshahi M, Brown RG, Whitehouse C, Quinn N, Marsden CD. Contact with a nurse practitioner: a short-term evaluation study in Parkinson's disease and dystonia. Behav Neurol. 1994;7(3):189-96. doi: 10.3233/BEN-1994-73-414.</citation>
    <PMID>24487336</PMID>
  </reference>
  <reference>
    <citation>Reynolds H, Wilson-Barnett J, Richardson G. Evaluation of the role of the Parkinson's disease nurse specialist. Int J Nurs Stud. 2000 Aug;37(4):337-49. doi: 10.1016/s0020-7489(00)00013-4.</citation>
    <PMID>10760541</PMID>
  </reference>
  <reference>
    <citation>Jarman B, Hurwitz B, Cook A, Bajekal M, Lee A. Effects of community based nurses specialising in Parkinson's disease on health outcome and costs: randomised controlled trial. BMJ. 2002 May 4;324(7345):1072-5. doi: 10.1136/bmj.324.7345.1072.</citation>
    <PMID>11991913</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Parkinson's disease nurse specialist</keyword>
  <keyword>Nursing</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cost-effectiveness</keyword>
  <keyword>Multidisciplinary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03830190/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830190
org study id: NICE-PD
nct id: NCT03830190
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Current guidelines recommend that every person with Parkinson's disease (PD)
      should have access to Parkinson's Disease Nurse Specialist (PDNS) care. Thus, hospitals
      increasingly offer PDNS care to their patients with PD. However, there is currently little
      scientific evidence on the cost-effectiveness of PDNS care. Consequently, many hospitals lack
      the nursing capacity to offer PDNS care to all patients, which creates unequal access to care
      and possibly avoidable disability and costs.

      Objective: The investigators aim to study the (cost-)effectiveness of specialized nursing
      care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages.
      To gain more insight into the used interventions and their effects, a subgroup analysis will
      be performed based on disease duration (diagnosis made <5, 5-10, or >10 years ago).

      Methods: The investigators will perform an 18-month, single-blind, randomized controlled
      clinical trial in eight community hospitals in the Netherlands. A total of 240 people with
      idiopathic PD that have not been treated by a PDNS over the past two years will be included,
      independent of disease severity or duration. In each hospital, 30 patients will randomly be
      allocated in a 1:1 ratio to either PDNS care according to the Dutch Guideline on PDNS care or
      no nursing intervention (continuing usual care). For the allocation of participants, a
      computer-generated list of random numbers will be used. The co-primary outcome measures are
      Quality of Life (QoL) and motor symptoms. Secondary outcomes include PD symptoms, mobility,
      non-motor symptoms, health-related quality of life, experienced quality of care,
      self-management, medication adherence, caregiver quality of life, coping skills and caregiver
      burden. Data will be collected after 12 months and 18 months. A healthcare utilization and
      productivity loss questionnaire will be completed every 3 months by both the patient and the
      caregiver.

      Hypothesis: The investigators hypothesize that, by offering more patients access to PDNS
      care, QoL will increase with equal healthcare costs. Increasing direct medical costs (for
      nurse staffing) will be offset by a reduced number of consultations with the general
      practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care
      is needed.
1. Background The Parkinson's Disease Nurse Specialist (PDNS) can fulfill a pivotal role in
           the multidisciplinary team of people with PD. The PDNS was introduced in 1989 in the
           United Kingdom to bridge the gap between medical management and the unique personal
           needs of patients. To obtain greater uniformity in care delivery by a PDNS and to
           facilitate the efficacy of nursing care in PD, the Dutch Guideline 'Nursing care in
           Parkinson's disease' was published in 2016. The main roles of the PDNS are clearly
           described in the Guideline, and include 1) providing information, education and
           instruction; 2) supporting the patient and caregiver in the promotion of
           self-management; 3) supporting psychosocial care questions; 4) prevention; 5)
           specialized diagnostic strategies and therapeutic nursing interventions; and 6)
           multidisciplinary collaboration.

           Based on expert opinion from healthcare professionals, the Dutch guideline advises that
           every person with PD could benefit from PDNS care, including those in early-stage
           disease where delivery of information, education about medication compliance and support
           in self-management are critical. So far, only three studies have evaluated PDNS care and
           they have found inconsistent results. Overall, they indicate that PDNS care may improve
           patient wellbeing, physical functioning and general health status and reduce anxiety and
           depression, but definite conclusions could not be drawn. Moreover, there is little
           evidence that shows that quality of life actually improves with PDNS care and to date,
           no studies have been performed that evaluated the cost-effectiveness of PDNS care.

           Currently, most hospitals in The Netherlands offer PDNS care, since it is advised in the
           Dutch Multidisciplinary Guideline. However many centers still lack the nursing capacity
           to offer PDNS care to all patients because the scientific evidence is inconclusive. This
           situation creates an undesirable inequality in access to care and presumably leads to
           avoidable disability and costs (e.g. from early admissions to nursing homes or crisis
           admissions to the hospital). Therefore, the investigators aim to study the
           cost-effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS
           care for people with PD.

        2. Study design The NICE-PD study is an 18-month, single-blind randomized controlled
           clinical trial that will be performed in eight community hospitals in the Netherlands. A
           total of 240 people with PD will be included (120 in each group) and equally distributed
           over the participating hospitals. The investigators have selected hospitals where, due
           to lack of sufficient PDNS staff, only a proportion of PD patients currently has access
           to PDNS care. This provides the investigators with a unique opportunity to identify
           patients who at present have no access to PDNS care, and to randomize them within
           hospitals (at the patient level) between PDNS care and no nursing intervention.

           Eligible patients will be allocated randomly to either PDNS care or usual care in a 1:1
           ratio, using a computer-generated list of random numbers. To ascertain an equal
           representation of patients, the investigators will stratify for disease duration
           (according to pre-defined subgroups, i.e. disease duration <5 years, 5-10 years and >10
           years). The PDNS intervention will be carried out according to the Dutch 'Guideline
           Nursing care in PD'. A blinded researcher will perform the clinical assessments at
           baseline (t0), after 12 months (t1) and after 18 months (t2). Patients and caregivers
           will also be asked to complete a set of questionnaires at t0, t1 and t2. Finally, every
           three months patients and their caregivers will complete an online questionnaire about
           healthcare utilization, costs and productivity loss.

        3. Intervention

           The PDNS intervention will be performed according to the Dutch 'Guideline Nursing care
           in PD' published in 2015. The intervention is not standardized, but tailored to the
           patients' and caregivers' needs. This includes the following:

             -  Assessment of individual care needs of people with PD and their caregivers. The
                PDNS performs a specific nursing assessment related to the medical, physical,
                psychological and social domains.

             -  Development of a patient-centered treatment plan that supports the patient and
                caregiver in self-management. The PDNS composes a multidisciplinary plan, based on
                the results of the individual assessment, and as prioritized by the patient and
                caregiver (shared decision making). The treatment plan is developed according to
                the national self-management framework.

             -  Specific nursing interventions. The intervention varies across disease stages and
                is tailored to the specific problems and needs of individual patients and their
                caregivers. The Guideline on PDNS care describes general- and specific nursing
                interventions. General interventions consist of providing information and
                education, disease management (e.g. considering advanced treatment options such as
                DBS) and monitoring (e.g. of caregiver burden). Specific nursing interventions are
                described for the following areas: mental functions, fatigue, sleep, urogenital
                functions, sexuality, medication adherence, orthostatic hypotension, caregiver
                burden, coping, mobility, self-management and dietary issues (table 2 provides
                examples of such interventions).

             -  Collaboration with other healthcare professionals. The PDNS stimulates and supports
                multidisciplinary collaboration between healthcare professionals based on the
                individual patient-centered treatment plan. The PDNS also plays a pivotal role in
                the timely referral to other healthcare professionals.

           The PDNS will keep a pre-defined electronic study report according to a structured
           format for each PD patient, documenting the individual care needs, present symptoms,
           performed interventions and (changes in) the individual care plan. This report will be
           started at the initial assessment and updated at every follow-up contact with the
           patient, e.g. at the outpatient clinic, during a telephone consultation or at a home
           visit. This data will be purposefully collected for a possible process analysis at the
           end of the study.

           Patients will have regular contact with their PDNS about the progress and realization of
           the personal goals, both during face-to-face contacts and by telephone, and sometimes
           during additional home visits. The frequency and type of contact will be optimized for
           each patient depending on disease stage and individual patient needs. The Guideline on
           PDNS care advises that each patient has a minimum of one contact with the PDNS each
           year. Currently in the Netherlands, patients are seen on average twice a year by their
           PDNS, with an additional two interim telephone consultations per year.

           The control group will receive ongoing/ usual care which is otherwise comparable, but
           without a nursing intervention. This involves regular consultations with a neurologist
           in their own community hospital (typically 2-4 times per year, depending on patient
           preferences and health status). In addition, control patients will have no other
           restrictions considering any other medical treatments (e.g. by a psychologist or social
           worker). Importantly, many important elements of care (including in particular the
           treating neurologist) remain comparable between the two intervention arms because of the
           randomization at patient level within hospitals.

        4. Clinical assessments At baseline, t1 and t2 all patients will visit their own hospital
           for the study assessments which are performed by a blinded researcher (PDQ-39,
           MDS-UPDRS, and TUG). Furthermore, the patients and their caregivers will complete
           additional home questionnaires. In addition, every three months, patients will receive a
           questionnaire at home regarding healthcare utilization, costs and productivity loss over
           the past three months. Caregivers will complete a cost questionnaire including
           healthcare utilization, costs and productivity loss specifically related to caregiver
           burden. Patients can choose if they want to fill out digital or paper questionnaires.

        5. Data analysis The economic evaluation investigates, alongside the clinical trial, the
           value for money of full implementation of the PDNS into PD care from a societal and
           healthcare perspective. The investigators will take all relevant costs into account. The
           cost-effectiveness timeframe adheres to the clinical study protocol and evaluates
           cost-effectiveness up to 18 months after randomization. Cost will be measured using a
           healthcare utilization questionnaire (e.g. including medical consultations, hospital
           admissions, medication, travel costs, etc.) and a questionnaire measuring productivity
           loss while working of both patients and caregivers. Per item of healthcare consumption,
           standard cost-prices will be determined using the guideline for performing economic
           evaluations. If standardized prices are not available, full cost prices will be
           determined using activity based costing. Costs will be analyzed using a mixed model
           approach or a general linear model approach with a gamma distribution using a log link
           to account for possible skewness of the cost data.

           The investigators will use a PD-specific quality of life measure (PDQ-39) and a generic
           health-related quality of life scale (EQ5D) to evaluate the quality of the health status
           of patients. The potential difference in Quality-Adjusted Life Years (QALYs) measured
           with the EQ5D will be analyzed with a regression approach. The investigators will use a
           linear mixed model with repeated measurements to test for differences in quality of life
           (measured with the PDQ-39) between both groups. The same analysis will be used to
           measure differences between groups in the secondary outcome measures. The investigators
           will include study center as a random effect and fixed effects for group, time and the
           interaction between group and time. Each of the outcomes will be included as dependent
           variable. Statistical analyses will be performed based on the intention-to-treat
           principle.

           Besides the overall cost-effectiveness evaluation, the investigators will perform a
           pre-planned subgroup analysis based on disease duration (diagnosis made <5 years, 5-10
           years or >10 years ago) to obtain more insight into the nursing interventions used in
           each disease stage and the effects of PDNS care in these different groups of patients.
           This subgroup analysis will be performed because, for example, for the more severely
           affected patients the nursing intervention is expected to become more intensive and
           possibly more effective, but also more expensive. When different patterns of this kind
           are found, this should be investigated further in future trials that are powered
           adequately to address such group differences.

        6. Discussion The investigators hypothesize that offering PDNS care will lead to higher
           quality of life with equal healthcare costs. Increasing direct medical costs (for nurse
           staffing) are expected to be offset by a reduced number of (telephone) consultations
           with the general practitioner and neurologist. These short-term goals are the focus of
           the present NICE-PD proposal. In addition to the short-term effects, the investigators
           also expect long-term benefits, which are out of scope of the present project. Examples
           of potential long-term benefits include a reduction in the number of nursing home
           admissions and fewer emergency visits to the hospital, which would lead to a substantial
           cost reduction.

      In conclusion, this study will generate new insights into the cost-effectiveness of
      specialized PD nursing interventions for people with PD. If positive results are found, a
      large shift in the organization of PD care is needed to warrant equal access to PDNS care for
      every person with PD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial with 2 study arms: the intervention group and the control group. Participants are allocated to each arm in a 1:1 ratio.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Due to the type of intervention (Parkinson's disease nurse specialist care), the participant and care provider cannot be masked. The investigator and outcome assessor (conducting the questionnaires) will be blinded.
measure: Disease-specific health-related quality of life: Parkinson's disease Questionnaire (PDQ-39)
time frame: Baseline, change from baseline quality of life at 12 months, change from baseline quality of life at 18 months
description: Parkinson's disease Questionnaire (PDQ-39). Total score range: 0-100, including 8 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.
measure: Motor symptoms
time frame: Baseline, change from baseline motor symptoms at 12 months, change from baseline motor symptoms at 18 months
description: Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III). Total score range: 0-132. A lower score means a better outcome.
measure: Longitudinal Parkinson's disease symptoms
time frame: Baseline, change from baseline Parkinson's disease symptoms at 12 months, change from baseline Parkinson's disease symptoms at 18 months
description: Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part I, II, IV (MDS-UPDRS part I, II, IV). Total score range: 0-260 (including the MDS-UPDRS part III), including 4 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.
measure: Mobility
time frame: Baseline, change from baseline TUG at 12 months, change from baseline TUG at 18 months
description: Timed up and Go (TUG). A lower score means a better outcome.
measure: Non-motor symptoms (anxiety and depression)
time frame: Baseline, 12 months, 18 months
description: Hamilton Anxiety and Depression Scale (HADS). Total score range: 0-21, including 2 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.
measure: Non-motor symptoms
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Scales for Outcomes in Parkinson's disease - Autonomic Questionnaire (SCOPA-AUT). Total score range: 0-69, including 6 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.
measure: Health-related quality of life: EuroQoL5D (EQ5D)
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: EuroQoL5D (EQ5D). Summary index with a maximum score of 1, including 5 dimensions. A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general health status with a total score range of 0-100. A higher score means a better outcome.
measure: Experienced quality of and experience with provided healthcare: Consumer Quality Index (CQI)
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Consumer Quality Index (CQI). There is no minimum or maximum score (the measure consists of a number of qualitative and experience questions). Therefore, higher values do not correlate with a better or worse outcome.
measure: Self-management
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Patient Activation Measure (PAM13). Total score range: 0-100, including a division in 4 activation levels. A higher score means a higher activation level (= the patient has made most of the necessary behavior changes to manage their disease).
measure: Medication adherence
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Morisky Medication Adherence Scale (MMAS). Total score range: 0-8. A higher score means a better outcome.
measure: Health-related quality of life of the caregiver: EuroQoL5D (EQ5D)
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: EuroQoL5D (EQ5D). Summary index with a maximum score of 1, including 5 dimensions. A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general health status with a total score range of 0-100. A higher score means a better outcome.
measure: Caregiver burden
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Zarit Caregiver Burden Index (ZBI). Total score range: 0-88. A lower score means a better outcome.
measure: Caregiver quality of life: CarerQol-7D
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: CarerQol-7D. Total score range: 0-14 (weighted sum score: 0-100). A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general well-being with a total score range of 0-10. A higher score means a better outcome.
measure: Skills of proactive coping of the caregiver
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Utrecht Proactive Coping Competence Scale (UPCC). Total score range: 21-84. A higher score means a better outcome.
measure: Medical consumption of the patient
time frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months
description: Medical Consumption Questionnaire (MCQ). There is no minimum or maximum score, this scale is a generic instrument for measuring medical costs.
measure: Productivity loss of the patient
time frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months
description: Productivity Cost Questionnaire (PCQ). There is no minimum or maximum score, this scale is a generic instrument to measure productivity losses related to the disease.
measure: Medical consumption of the caregiver related to providing care to the patient
time frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months
description: Adjusted version of the Medical Consumption Questionnaire (MCQ). There is no minimum or maximum score, this scale is a generic instrument for measuring medical costs.
measure: Productivity loss of the caregiver related to providing care to the patient
time frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months
description: Adjusted version of the Productivity Cost Questionnaire (PCQ). There is no minimum or maximum score, this scale is a generic instrument to measure productivity losses related to being a caregiver.
measure: Nighttime sleep problems and daytime sleepiness
time frame: Baseline, change from baseline at 12 months, change from baseline at 18 months
description: Scales for Outcomes in Parkinson's disease - Sleep Questionnaire (SCOPA-SLEEP). Total score range: 0-33, including 2 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.
arm group label: Intervention group
arm group type: Experimental
description: Parkinson's disease nurse specialist care
arm group label: Control group
arm group type: No Intervention
description: No intervention
intervention type: Other
intervention name: Parkinson's disease nurse specialist care
description: Specialized nursing care provided by a Parkinson's disease nurse specialist
arm group label: Intervention group
other name: PDNS care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bastiaan R Bloem, MD, PhD
role: Principal Investigator
affiliation: Department of Neurology, Radboudumc, Nijmegen, The Netherlands.
last name: Nienke M de Vries, PhD
phone: 003124-3615213
email: nienke.devries-farrouh@radboudumc.nl
last name: Danique LM Radder, MD
phone: 003124-3655345
email: danique.radder@radboudumc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Netherlands
url: http://parkinsonnet.info/media/2733747/7994_multidisciplin_rl_parkinson_c_-_2011.pdf
description: Dutch Multidisciplinary Guideline for Parkinson's disease
citation: Lennaerts H, Groot M, Rood B, Gilissen K, Tulp H, van Wensen E, Munneke M, van Laar T, Bloem BR. A Guideline for Parkinson's Disease Nurse Specialists, with Recommendations for Clinical Practice. J Parkinsons Dis. 2017;7(4):749-754. doi: 10.3233/JPD-171195.
PMID: 28800338
citation: Jahanshahi M, Brown RG, Whitehouse C, Quinn N, Marsden CD. Contact with a nurse practitioner: a short-term evaluation study in Parkinson's disease and dystonia. Behav Neurol. 1994;7(3):189-96. doi: 10.3233/BEN-1994-73-414.
PMID: 24487336
citation: Reynolds H, Wilson-Barnett J, Richardson G. Evaluation of the role of the Parkinson's disease nurse specialist. Int J Nurs Stud. 2000 Aug;37(4):337-49. doi: 10.1016/s0020-7489(00)00013-4.
PMID: 10760541
citation: Jarman B, Hurwitz B, Cook A, Bajekal M, Lee A. Effects of community based nurses specialising in Parkinson's disease on health outcome and costs: randomised controlled trial. BMJ. 2002 May 4;324(7345):1072-5. doi: 10.1136/bmj.324.7345.1072.
PMID: 11991913
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No
provided document: 