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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Chronic disease self-management program; Other: General psychiatric intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Wanhua Dist
    • Taipei, Wanhua Dist, Taiwan, 108306
      • National Taipei University of Nursing and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-management group; 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.	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.
Placebo Comparator: Control group; Control group will continue general psychiatric intervention.	Other: General psychiatric intervention; General psychiatric intervention contains the activities in psychiatric center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Study Director: En-Chi Chiu, PhD, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): December 25, 2020
• Study Completion (Actual): December 25, 2020

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: chronic disease self-management program
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Chronic Disease
• Other Study ID Numbers: TCHIRB-10904004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No