<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/NCT02992431</url>
  </required_header>
  <id_info>
    <org_study_id>749-1-2017</org_study_id>
    <nct_id>NCT02992431</nct_id>
  </id_info>
  <brief_title>Participatory Patient Care Planning in Primary Care</brief_title>
  <acronym>4PHC</acronym>
  <official_title>Participatory Patient Care Planning in Primary Care: Effectiveness and Feasibility in Patients With Hypertension, Ischemic Heart Disease or Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Siilinjärvi Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Eastern Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the aging population, the prevalence of chronic diseases and multimorbidity has become&#xD;
      common. Therefore, the planning and coordination of care have become more important. However,&#xD;
      it is not known what kind of treatment plan should be and what kind of patients would benefit&#xD;
      most of it.&#xD;
&#xD;
      This research focuses on the participatory patient care planning in primary health care. In&#xD;
      general, the participatory patient care planning (PPCP) aims to engage patients in self-care,&#xD;
      to improve the collaboration between patients and professionals and to improve the use of&#xD;
      resources. The present study investigates the feasibility and effectiveness of the PPCP.&#xD;
&#xD;
      The specific research questions of the present study are: Does the PPCP have an impact on the&#xD;
      patient's quality of life? Does the PPCP improve the quality of care in management of chronic&#xD;
      diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on&#xD;
      the use of health care services? The data consists of people aged at least 18 years living in&#xD;
      the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who&#xD;
      are recorded in in Siilinjärvi Health Care Center electronic patient record. The&#xD;
      participating patients are recruited from those who contacts SiiIinjärvi Health Care Center&#xD;
      in order to have a follow-up visit because of the treatment of their disease. This study aims&#xD;
      to recruit 700 patients.&#xD;
&#xD;
      The participants are allocated into the intervention group and into the control group&#xD;
      receiving usual care. Intervention consists of the PPCP. This includes the patient activation&#xD;
      questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist&#xD;
      measurement, weight and length) and a visit to the general practitioner who discusses and&#xD;
      agrees with the patient about the treatment goals and follow-up resulting in the written&#xD;
      PPCP.&#xD;
&#xD;
      The main out-come measures are the quality of health related life measured with the 15D; the&#xD;
      level of patient's activity in self-care with the Patient Activation Measurement (PAM); life&#xD;
      satisfaction, self-rated health, a reduction in productivity with the Work Productivity and&#xD;
      Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood&#xD;
      pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain&#xD;
      intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls&#xD;
      and referrals are measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research focuses on the participatory patient care planning in primary health care. In&#xD;
      general, the participatory patient care planning (PPCP) aims to engage patients in self-care,&#xD;
      to improve the collaboration between patients and professionals and to improve the use of&#xD;
      resources. The present study investigates the feasibility and effectiveness of the PPCP.&#xD;
&#xD;
      The specific research questions of the present study are: Does the PPCP have an impact on the&#xD;
      patient's quality of life? Does the PPCP improve the quality of care in management of chronic&#xD;
      diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on&#xD;
      the use of health care services? The data consists of people aged at least 18 years living in&#xD;
      the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who&#xD;
      are recorded in in Siilinjärvi Health Care Center electronic patient record. The&#xD;
      participating patients are recruited from those who contacts SiiIinjärvi Health Care Center&#xD;
      in order to have a follow-up visit because of the treatment of their disease. This study aims&#xD;
      to recruit 700 patients.&#xD;
&#xD;
      The participants are allocated into the intervention group and into the control group&#xD;
      receiving usual care. Intervention consists of the PPCP. This includes the patient activation&#xD;
      questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist&#xD;
      measurement, weight and length) and a visit to the general practitioner who discusses and&#xD;
      agrees with the patient about the treatment goals and follow-up resulting in the written&#xD;
      PPCP.&#xD;
&#xD;
      The main out-come measures are the quality of health related life measured with the 15D; the&#xD;
      level of patient's activity in self-care with the Patient Activation Measurement (PAM); life&#xD;
      satisfaction, self-rated health, a reduction in productivity with the Work Productivity and&#xD;
      Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood&#xD;
      pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain&#xD;
      intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls&#xD;
      and referrals are measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>15D</measure>
    <time_frame>one year</time_frame>
    <description>Health related quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WPAI</measure>
    <time_frame>one year</time_frame>
    <description>Work Productivity and Activity Impairment Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAM</measure>
    <time_frame>one year</time_frame>
    <description>Patient Activation Measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>one year</time_frame>
    <description>B -Hemoglobin-A1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL</measure>
    <time_frame>one year</time_frame>
    <description>plasma LDL cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>one year</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>one year</time_frame>
    <description>body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist measure</measure>
    <time_frame>one year</time_frame>
    <description>waist measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visits to nurse</measure>
    <time_frame>one year</time_frame>
    <description>number of visits to nurse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visits to physician</measure>
    <time_frame>one year</time_frame>
    <description>number of visits to physician</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Hypertension</condition>
  <condition>Ischemic Heart Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care including standard disease specific follow-up with visit to general practitioner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participatory patient care planning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Participatory patient care planning</intervention_name>
    <description>Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.</description>
    <arm_group_label>Participatory patient care planning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual care including standard disease specific follow-up with visit to general practitioner.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with hypertension, ischemic hearth disease or diabetes living in the&#xD;
             municipality of Siilinjärvi&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Permanent bed patient, terminal phase of any serious condition, severe decline in&#xD;
             cognition&#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>Pekka T Mäntyselkä, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Eastern Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nina M Tusa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Eastern Finland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siilinjärvi Health Center</name>
      <address>
        <city>Siilinjärvi</city>
        <zip>71800</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuopio University Hospital</investigator_affiliation>
    <investigator_full_name>Pekka Mäntyselkä</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>patient care planning</keyword>
  <keyword>primary health care</keyword>
  <keyword>comorbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02992431
org study id: 749-1-2017
nct id: NCT02992431
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In the aging population, the prevalence of chronic diseases and multimorbidity has become
      common. Therefore, the planning and coordination of care have become more important. However,
      it is not known what kind of treatment plan should be and what kind of patients would benefit
      most of it.

      This research focuses on the participatory patient care planning in primary health care. In
      general, the participatory patient care planning (PPCP) aims to engage patients in self-care,
      to improve the collaboration between patients and professionals and to improve the use of
      resources. The present study investigates the feasibility and effectiveness of the PPCP.

      The specific research questions of the present study are: Does the PPCP have an impact on the
      patient's quality of life? Does the PPCP improve the quality of care in management of chronic
      diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on
      the use of health care services? The data consists of people aged at least 18 years living in
      the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who
      are recorded in in Siilinjärvi Health Care Center electronic patient record. The
      participating patients are recruited from those who contacts SiiIinjärvi Health Care Center
      in order to have a follow-up visit because of the treatment of their disease. This study aims
      to recruit 700 patients.

      The participants are allocated into the intervention group and into the control group
      receiving usual care. Intervention consists of the PPCP. This includes the patient activation
      questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist
      measurement, weight and length) and a visit to the general practitioner who discusses and
      agrees with the patient about the treatment goals and follow-up resulting in the written
      PPCP.

      The main out-come measures are the quality of health related life measured with the 15D; the
      level of patient's activity in self-care with the Patient Activation Measurement (PAM); life
      satisfaction, self-rated health, a reduction in productivity with the Work Productivity and
      Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood
      pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain
      intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls
      and referrals are measured.
This research focuses on the participatory patient care planning in primary health care. In
      general, the participatory patient care planning (PPCP) aims to engage patients in self-care,
      to improve the collaboration between patients and professionals and to improve the use of
      resources. The present study investigates the feasibility and effectiveness of the PPCP.

      The specific research questions of the present study are: Does the PPCP have an impact on the
      patient's quality of life? Does the PPCP improve the quality of care in management of chronic
      diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on
      the use of health care services? The data consists of people aged at least 18 years living in
      the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who
      are recorded in in Siilinjärvi Health Care Center electronic patient record. The
      participating patients are recruited from those who contacts SiiIinjärvi Health Care Center
      in order to have a follow-up visit because of the treatment of their disease. This study aims
      to recruit 700 patients.

      The participants are allocated into the intervention group and into the control group
      receiving usual care. Intervention consists of the PPCP. This includes the patient activation
      questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist
      measurement, weight and length) and a visit to the general practitioner who discusses and
      agrees with the patient about the treatment goals and follow-up resulting in the written
      PPCP.

      The main out-come measures are the quality of health related life measured with the 15D; the
      level of patient's activity in self-care with the Patient Activation Measurement (PAM); life
      satisfaction, self-rated health, a reduction in productivity with the Work Productivity and
      Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood
      pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain
      intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls
      and referrals are measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: 15D
time frame: one year
description: Health related quality of life
measure: WPAI
time frame: one year
description: Work Productivity and Activity Impairment Questionnaire
measure: PAM
time frame: one year
description: Patient Activation Measurement
measure: HbA1C
time frame: one year
description: B -Hemoglobin-A1c
measure: LDL
time frame: one year
description: plasma LDL cholesterol
measure: blood pressure
time frame: one year
description: blood pressure
measure: BMI
time frame: one year
description: body mass index
measure: waist measure
time frame: one year
description: waist measure
measure: visits to nurse
time frame: one year
description: number of visits to nurse
measure: visits to physician
time frame: one year
description: number of visits to physician
arm group label: Usual care
arm group type: Active Comparator
description: Usual care including standard disease specific follow-up with visit to general practitioner.
arm group label: Participatory patient care planning
arm group type: Experimental
description: Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
intervention type: Behavioral
intervention name: Participatory patient care planning
description: Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
arm group label: Participatory patient care planning
intervention type: Other
intervention name: Usual care
description: Usual care including standard disease specific follow-up with visit to general practitioner.
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pekka T Mäntyselkä, Professor
role: Study Chair
affiliation: University of Eastern Finland
last name: Nina M Tusa, MD
role: Principal Investigator
affiliation: University of Eastern Finland
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Kuopio University Hospital
investigator full name: Pekka Mäntyselkä
investigator title: Professor
mesh term: Hypertension
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: No