Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of Reablement-Instrumental Activities of Daily Living (RE-IADL) on schizophrenia patients at immediately and long-term.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: RE-IADL; Other: General community rehabilitation

Detailed Description

Subjects will be randomized to intervention group and control group. The outcome measures include the Canadian Occupational Performance Measure, Instrumental Activities of Daily Living-3 Dimensions, Activities of Daily Living Rating Scale III, Frenchay Activities Index, Lawton Instrumental Activities of Daily Living, Mini Mental State Examination-2nd edition, Behavior Rating Inventory of Executive Function adult version, Allen Cognitive Level Screen-6th, Participation Measure-3 Domains, 4 Dimensions, Personal and Social Performance scale, Work Behavior Inventory, Schizophrenia-Quality of Life questionnaire, Beck Depression Inventory-II, and Functioning Scale of the Disability Evaluation System.

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

Contacts and Locations

• Study Contact: Name: En-Chi Chiu, PhD; Phone Number: 6206 +886-2-28227101; Email: enchichiu@ntunhs.edu.tw

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

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: RE-IADL group; Reablement	Other: RE-IADL; RE-IADL program is to conduct trainings related to instrumental activities of daily living. For example,using communication appliance, moving in community, financial management, health care, housework, prepare meals and clear ,and shopping.
Placebo Comparator: Control group; General community rehabilitation	Other: General community rehabilitation; General community rehabilitation contains the activities in psychiatric rehabilitation center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the Canadian Occupational Performance Measure	The Canadian Occupational Performance Measure assesses occupational performance. A higher score indicates better occupational performance. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Instrumental Activities of Daily Living-3 Dimensions	The Instrumental Activities of Daily Living-3 Dimensions assesses instrumental activities of daily living about 3 Dimensions. A higher score indicates better instrumental activities of daily living. Changes of the Instrumental Activities of Daily Living-3 Dimensions will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Activities of Daily Living Rating Scale III	The Activities of Daily Living Rating Scale III assesses activities of daily living. A higher score indicates better activities of daily living. Changes of the Activities of Daily Living Rating Scale III well be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Frenchay Activity Index	The Frenchay Activity Index assesses instrumental activities of daily. A higher score indicates better instrumental activities of daily living. Changes of the Frenchay Activity Index will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Lawton Instrumental Activities of Daily Living	The Lawton Instrumental Activities of Daily Living assesses instrumental activities of daily living. A higher scores indicates better instrumental activities of daily living. Changes of the Lawton Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Mini Mental State Examination-2nd edition	The Mini Mental State Examination assesses general cognitive function. A higher score indicates better general cognitive function. Changes of the Mini Mental State Examination will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Behavior Rating Inventory of Executive Function adult version	The Behavior Rating Inventory of Executive Function adult version assesses executive functions. A lower score indicates better executive functions. Changes of the Behavior Rating Inventory of Executive Function adult version will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Allen Cognitive Level Screen-6th	The Allen Cognitive Level Screen-6th assesses cognitive functions. A higher score indicates better cognitive functions. Changes of the Allen Cognitive Level Screen-6th will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Participation Measure-3 Domains, 4 Dimensions	The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of the Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Personal and Social Performance scale	The Personal and Social Performance scale assesses social functioning. A higher score indicates better social functioning. Changes of the Personal and Social Performance scale will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Work Behavior Inventory	The Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of the Work Behavior Inventory will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Schizophrenia-Quality of Life questionnaire	The Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of the Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Beck Depression Inventory-II	The Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression. Changes of the Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks
Changes of the Functioning Scale of the Disability Evaluation System	The Functioning Scale of the Disability Evaluation System assesses status of individuals' activities and participation. A higher score indicates more barriers or limitations. Changes of the Functioning Scale of the Disability Evaluation System will be assessed at the 0 week, 6 weeks, and 18 weeks.	18 weeks

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): November 30, 2021
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: instrumental activities of daily living; reablement
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: TCHIRB-10812015

Drug and device information, study documents

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