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

• Sponsor: National Taipei University of Nursing and Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04503954
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 22.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Other: Chronic disease self-management program; Other: General psychiatric intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
• Actual Study Start Date: Sep 7, 2020
• Actual Primary Completion Date: Dec 25, 2020
• Actual Study Completion Date: Dec 25, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Stanford Self-Management Questionnaire [6 week]

   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.

2. Beck Depression Inventory-II, [6 week]

   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.

3. Activities of Daily Living Rating Scale III, [6 week]

   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.

4. Instrumental Activities of Daily Living [6 week]

   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.

5. Participation Measure-3 Domains Domains, 4 Dimensions [6 week]

   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. Work Behavior Inventory [6 week]

   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.

7. Schizophrenia-Quality of Life questionnaire [6 week]

   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.

8. Mini Mental State Examination-2nd edition [6 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taipei University of Nursing and Health Sciences	Taipei	Wanhua Dist	Taiwan	108306

Sponsors and Collaborators

• National Taipei University of Nursing and Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: En-Chi Chiu, Associate Professor, National Taipei University of Nursing and Health Sciences
• ClinicalTrials.gov Identifier: NCT04503954
• Other Study ID Numbers: TCHIRB-10904004
• First Posted: Aug 7, 2020
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by En-Chi Chiu, Associate Professor, National Taipei University of Nursing and Health Sciences: chronic disease self-management program
• Additional relevant MeSH terms: Chronic Disease; Schizophrenia

Study Results

No Results Posted as of Nov 16, 2021