<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/NCT03772639</url>
  </required_header>
  <id_info>
    <org_study_id>DF0082UG</org_study_id>
    <nct_id>NCT03772639</nct_id>
  </id_info>
  <brief_title>Shared Decision Making in Hospitalized AECOPD</brief_title>
  <official_title>Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</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>
      Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality&#xD;
      worldwide. Patients require good communication with the physician to improve control illness.&#xD;
      Shared decision making is a promising opportunity for chronic disease management due to the&#xD;
      relative cost, medicine optimization and decreases hospital admissions/re-admissions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is the leading one on hospital care cost,&#xD;
      physician services, and prescription drugs. Additionally to the disease progression with the&#xD;
      reduction in lung function, COPD patients experiment a progressive decline in functional&#xD;
      capacity and health-related quality of life (HRQoL) with a significant burden in terms of&#xD;
      disability. Shared Decision Making is defined as an approach where clinicians and patients&#xD;
      share the available information to making clinical decisions, and where patients are&#xD;
      counseled. SDM is a way to empower patients when decisions are made about treatment as a&#xD;
      determinant factor in patient-centered care. Decision aids have been proven effective in&#xD;
      improving disease knowledge, decision making, and self-care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>European Quality of Life questionnaire consists of the EQ-5D visual analog scale and the EQ-5D index. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health). The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COPD Knowledge</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q). COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, &amp; Wallace, 2010). The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills. A higher punctuation indicates better results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence of inhalers</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>The Test of Adherence to Inhalers (TAI) was used to assess the level of adherence to inhalers in asthma and COPD patients. The test has two subscores, first to identify non-adherent patients and to measure the non-adherence level, second was designed to guide clinically the treatment non-compliance patients. Low adherence is considered when scores are less than 45 points in the 10-items subscore.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>Functional independence was assessed using the Functional Independence Mease Scale (FIM). This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items. The total score range between 18 points (total dependence) to 126 points (Independence completes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>Nutritional status was assessed with Mini Nutritional Assessment (MNA). The MNA has a screening- and assessment part. The screening part consists of questions about food intake, weight loss, mobility, stress, neuropsychological problems and weight and height will be combined to report BMI in kg/m^2. When the MNA punctuation is ≥ 24 nutritional status can be considered good.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity associated with breathlessness</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up</time_frame>
    <description>Functional capacity associated with breathlessness was assessed with London Chest Activity of Daily Living Scale (LCADL): The LCADL is a 15-item scale divided into 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). The use of 0 representing 'I wouldn't do any way' and 5 representing that patients require help.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group received a standard medical and pharmacological care in a daily format and shared decision making (SDM). The general framework of SDM was developed focusing on self-management goals which include education that addresses continuous use of medication, behavioral change, breathing training, learning to interpret changes in the disease and its consequences, and use of medical and community resources.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group received standard care and pharmacological care including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shared decision making</intervention_name>
    <description>Decision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria were COPD patients hospitalized due to acute exacerbation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were the inability to provide informed consent, the presence of&#xD;
             psychiatric or cognitive disorders, progressive neurological disorders, organ failure,&#xD;
             cancer, or inability to cooperate. Patients who had experienced another exacerbation&#xD;
             of COPD in the previous month were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>February 17, 2020</last_update_submitted>
  <last_update_submitted_qc>February 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Marie Carmen Valenza</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03772639
org study id: DF0082UG
nct id: NCT03772639
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality
      worldwide. Patients require good communication with the physician to improve control illness.
      Shared decision making is a promising opportunity for chronic disease management due to the
      relative cost, medicine optimization and decreases hospital admissions/re-admissions
Chronic obstructive pulmonary disease (COPD) is the leading one on hospital care cost,
      physician services, and prescription drugs. Additionally to the disease progression with the
      reduction in lung function, COPD patients experiment a progressive decline in functional
      capacity and health-related quality of life (HRQoL) with a significant burden in terms of
      disability. Shared Decision Making is defined as an approach where clinicians and patients
      share the available information to making clinical decisions, and where patients are
      counseled. SDM is a way to empower patients when decisions are made about treatment as a
      determinant factor in patient-centered care. Decision aids have been proven effective in
      improving disease knowledge, decision making, and self-care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Health related quality of life
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: European Quality of Life questionnaire consists of the EQ-5D visual analog scale and the EQ-5D index. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health). The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).
measure: COPD Knowledge
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q). COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, & Wallace, 2010). The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills. A higher punctuation indicates better results.
measure: Adherence of inhalers
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: The Test of Adherence to Inhalers (TAI) was used to assess the level of adherence to inhalers in asthma and COPD patients. The test has two subscores, first to identify non-adherent patients and to measure the non-adherence level, second was designed to guide clinically the treatment non-compliance patients. Low adherence is considered when scores are less than 45 points in the 10-items subscore.
measure: Functional capacity
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: Functional independence was assessed using the Functional Independence Mease Scale (FIM). This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items. The total score range between 18 points (total dependence) to 126 points (Independence completes).
measure: Physical activity
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.
measure: Nutritional status
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: Nutritional status was assessed with Mini Nutritional Assessment (MNA). The MNA has a screening- and assessment part. The screening part consists of questions about food intake, weight loss, mobility, stress, neuropsychological problems and weight and height will be combined to report BMI in kg/m^2. When the MNA punctuation is ≥ 24 nutritional status can be considered good.
measure: Functional capacity associated with breathlessness
time frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
description: Functional capacity associated with breathlessness was assessed with London Chest Activity of Daily Living Scale (LCADL): The LCADL is a 15-item scale divided into 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). The use of 0 representing 'I wouldn't do any way' and 5 representing that patients require help.
arm group label: Experimental group
arm group type: Experimental
description: The experimental group received a standard medical and pharmacological care in a daily format and shared decision making (SDM). The general framework of SDM was developed focusing on self-management goals which include education that addresses continuous use of medication, behavioral change, breathing training, learning to interpret changes in the disease and its consequences, and use of medical and community resources.
arm group label: Control Group
arm group type: No Intervention
description: The control group received standard care and pharmacological care including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy.
intervention type: Other
intervention name: Shared decision making
description: Decision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Marie Carmen Valenza
investigator title: Principal Investigator
sharing ipd: Undecided