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

NCT04503954 | Completed

• 1 other identifier: TCHIRB-10904004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

chronic disease self-management program

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Self-management group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Control group will continue general psychiatric intervention.

Other: General psychiatric intervention

Interventions

Chronic disease self-management program OTHER

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.

Self-management group

General psychiatric intervention OTHER

General psychiatric intervention contains the activities in psychiatric center.

Control group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Wanhua Dist, 108306, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• En-Chi Chiu, PhD

  National Taipei University of Nursing and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: September 7, 2020
• Primary Completion: December 25, 2020
• Study Completion: December 25, 2020
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

TW (1)