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Efficacy of Chronic Disease Self-management Program in People With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chronic disease self-management program
General psychiatric intervention
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring chronic disease self-management program

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia by DSM-5
  • age > 20 years
  • Stable mental symptoms
  • Willing to sign the subject's consent

Exclusion Criteria:

  • History of severe brain injury
  • Substance abuse
  • Diagnosis of intellectual developmental disorder
  • Unable to follow instructions

Sites / Locations

  • National Taipei University of Nursing and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Self-management group

Control group

Arm 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.

Control group will continue general psychiatric intervention.

Outcomes

Primary Outcome Measures

Stanford Self-Management Questionnaire
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.
Beck Depression Inventory-II,
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.
Activities of Daily Living Rating Scale III,
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.
Instrumental Activities of Daily Living
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.
Participation Measure-3 Domains Domains, 4 Dimensions
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.
Work Behavior Inventory
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.
Schizophrenia-Quality of Life questionnaire
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.
Mini Mental State Examination-2nd edition
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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
November 8, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04503954
Brief Title
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
Official Title
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
December 25, 2020 (Actual)
Study Completion Date
December 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
chronic disease self-management program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management group
Arm Type
Experimental
Arm 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 Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group will continue general psychiatric intervention.
Intervention Type
Other
Intervention Name(s)
Chronic disease self-management program
Intervention 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.
Intervention Type
Other
Intervention Name(s)
General psychiatric intervention
Intervention Description
General psychiatric intervention contains the activities in psychiatric center.
Primary Outcome Measure Information:
Title
Stanford Self-Management Questionnaire
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.
Time Frame
6 week
Title
Beck Depression Inventory-II,
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.
Time Frame
6 week
Title
Activities of Daily Living Rating Scale III,
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.
Time Frame
6 week
Title
Instrumental Activities of Daily Living
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.
Time Frame
6 week
Title
Participation Measure-3 Domains Domains, 4 Dimensions
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.
Time Frame
6 week
Title
Work Behavior Inventory
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.
Time Frame
6 week
Title
Schizophrenia-Quality of Life questionnaire
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.
Time Frame
6 week
Title
Mini Mental State Examination-2nd edition
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.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia by DSM-5 age > 20 years Stable mental symptoms Willing to sign the subject's consent Exclusion Criteria: History of severe brain injury Substance abuse Diagnosis of intellectual developmental disorder Unable to follow instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Chi Chiu, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei
State/Province
Wanhua Dist
ZIP/Postal Code
108306
Country
Taiwan

12. IPD Sharing Statement

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Efficacy of Chronic Disease Self-management Program in People With Schizophrenia

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