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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503954
• Other study ID #: TCHIRB-10904004
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: December 25, 2020

Study information

• Verified date: November 2021
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Schizophrenia

Intervention

Other:
• Chronic disease self-management program
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.
• General psychiatric intervention
General psychiatric intervention contains the activities in psychiatric center.

Locations

Country	Name	City	State
Taiwan	National Taipei University of Nursing and Health Sciences	Taipei	Wanhua Dist

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 week
Primary	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.	6 week
Primary	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.	6 week
Primary	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.	6 week
Primary	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.	6 week
Primary	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.	6 week
Primary	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.	6 week
Primary	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.	6 week