<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/NCT04503954</url>
  </required_header>
  <id_info>
    <org_study_id>TCHIRB-10904004</org_study_id>
    <nct_id>NCT04503954</nct_id>
  </id_info>
  <brief_title>Efficacy of Chronic Disease Self-management Program in People With Schizophrenia</brief_title>
  <official_title>Efficacy of Chronic Disease Self-management Program in People With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taipei University of Nursing and Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taipei University of Nursing and Health Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a randomized controlled behavioral intervention trial to assess the efficacy of&#xD;
      investigating program of chronic disease self-management program in people on schizophrenia&#xD;
      patients conditions of depression, activities of daily living, social function, work, and&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were randomized to intervention group and control group. The primary outcome&#xD;
      included eight measures, Stanford Self-Management Questionnaire, the Beck Depression&#xD;
      Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of&#xD;
      Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior&#xD;
      Inventory, and the Schizophrenia-Quality of Life questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2020</start_date>
  <completion_date type="Actual">December 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 25, 2020</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>Stanford Self-Management Questionnaire</measure>
    <time_frame>6 week</time_frame>
    <description>The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II,</measure>
    <time_frame>6 week</time_frame>
    <description>Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression.&#xD;
Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activities of Daily Living Rating Scale III,</measure>
    <time_frame>6 week</time_frame>
    <description>Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Instrumental Activities of Daily Living</measure>
    <time_frame>6 week</time_frame>
    <description>Instrumental Activities of Daily Living assesses instrumental activities of daily living.&#xD;
A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participation Measure-3 Domains Domains, 4 Dimensions</measure>
    <time_frame>6 week</time_frame>
    <description>Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Work Behavior Inventory</measure>
    <time_frame>6 week</time_frame>
    <description>Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schizophrenia-Quality of Life questionnaire</measure>
    <time_frame>6 week</time_frame>
    <description>Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini Mental State Examination-2nd edition</measure>
    <time_frame>6 week</time_frame>
    <description>Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function.&#xD;
Changes of Mini Mental State Examination will be assessed at the 0 week, 6 weeks.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Self-management group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Self-management group Chronic disease self-management program is conduct training skills, person how to live together with personal chronic disease to make life quality better.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group will continue general psychiatric intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chronic disease self-management program</intervention_name>
    <description>The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.</description>
    <arm_group_label>Self-management group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General psychiatric intervention</intervention_name>
    <description>General psychiatric intervention contains the activities in psychiatric center.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of schizophrenia by DSM-5&#xD;
&#xD;
          -  age &gt; 20 years&#xD;
&#xD;
          -  Stable mental symptoms&#xD;
&#xD;
          -  Willing to sign the subject's consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe brain injury&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Diagnosis of intellectual developmental disorder&#xD;
&#xD;
          -  Unable to follow instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>En-Chi Chiu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>National Taipei University of Nursing and Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taipei University of Nursing and Health Sciences</name>
      <address>
        <city>Taipei</city>
        <state>Wanhua Dist</state>
        <zip>108306</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>November 8, 2021</last_update_submitted>
  <last_update_submitted_qc>November 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taipei University of Nursing and Health Sciences</investigator_affiliation>
    <investigator_full_name>En-Chi Chiu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>chronic disease self-management program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04503954
org study id: TCHIRB-10904004
nct id: NCT04503954
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This was a randomized controlled behavioral intervention trial to assess the efficacy of
      investigating program of chronic disease self-management program in people on schizophrenia
      patients conditions of depression, activities of daily living, social function, work, and
      quality of life.
Subjects were randomized to intervention group and control group. The primary outcome
      included eight measures, Stanford Self-Management Questionnaire, the Beck Depression
      Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of
      Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior
      Inventory, and the Schizophrenia-Quality of Life questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Stanford Self-Management Questionnaire
time frame: 6 week
description: The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.
measure: Beck Depression Inventory-II,
time frame: 6 week
description: Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression.
Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.
measure: Activities of Daily Living Rating Scale III,
time frame: 6 week
description: Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.
measure: Instrumental Activities of Daily Living
time frame: 6 week
description: Instrumental Activities of Daily Living assesses instrumental activities of daily living.
A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.
measure: Participation Measure-3 Domains Domains, 4 Dimensions
time frame: 6 week
description: Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.
measure: Work Behavior Inventory
time frame: 6 week
description: Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.
measure: Schizophrenia-Quality of Life questionnaire
time frame: 6 week
description: Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.
measure: Mini Mental State Examination-2nd edition
time frame: 6 week
description: Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function.
Changes of Mini Mental State Examination will be assessed at the 0 week, 6 weeks.
arm group label: Self-management group
arm group type: Experimental
description: Self-management group Chronic disease self-management program is conduct training skills, person how to live together with personal chronic disease to make life quality better.
arm group label: Control group
arm group type: Placebo Comparator
description: Control group will continue general psychiatric intervention.
intervention type: Other
intervention name: Chronic disease self-management program
description: The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.
arm group label: Self-management group
intervention type: Other
intervention name: General psychiatric intervention
description: General psychiatric intervention contains the activities in psychiatric center.
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: En-Chi Chiu, PhD
role: Study Director
affiliation: National Taipei University of Nursing and Health Sciences
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taipei University of Nursing and Health Sciences
investigator full name: En-Chi Chiu
investigator title: Associate Professor
mesh term: Chronic Disease
mesh term: Schizophrenia