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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
RE-IADL
General community rehabilitation
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring reablement, instrumental activities of daily living

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taipei University of Nursing and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RE-IADL group

Control group

Arm Description

Reablement

General community rehabilitation

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2020
Last Updated
August 31, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04350775
Brief Title
Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia
Official Title
Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
reablement, instrumental activities of daily living

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RE-IADL group
Arm Type
Experimental
Arm Description
Reablement
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
General community rehabilitation
Intervention Type
Other
Intervention Name(s)
RE-IADL
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General community rehabilitation
Intervention Description
General community rehabilitation contains the activities in psychiatric rehabilitation center.
Primary Outcome Measure Information:
Title
Changes of the Canadian Occupational Performance Measure
Description
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.
Time Frame
18 weeks
Title
Changes of the Instrumental Activities of Daily Living-3 Dimensions
Description
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.
Time Frame
18 weeks
Title
Changes of the Activities of Daily Living Rating Scale III
Description
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.
Time Frame
18 weeks
Title
Changes of the Frenchay Activity Index
Description
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.
Time Frame
18 weeks
Title
Changes of the Lawton Instrumental Activities of Daily Living
Description
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.
Time Frame
18 weeks
Title
Changes of the Mini Mental State Examination-2nd edition
Description
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.
Time Frame
18 weeks
Title
Changes of the Behavior Rating Inventory of Executive Function adult version
Description
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.
Time Frame
18 weeks
Title
Changes of the Allen Cognitive Level Screen-6th
Description
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.
Time Frame
18 weeks
Title
Changes of the Participation Measure-3 Domains, 4 Dimensions
Description
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.
Time Frame
18 weeks
Title
Changes of the Personal and Social Performance scale
Description
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.
Time Frame
18 weeks
Title
Changes of the Work Behavior Inventory
Description
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.
Time Frame
18 weeks
Title
Changes of the Schizophrenia-Quality of Life questionnaire
Description
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.
Time Frame
18 weeks
Title
Changes of the Beck Depression Inventory-II
Description
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.
Time Frame
18 weeks
Title
Changes of the Functioning Scale of the Disability Evaluation System
Description
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.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Chi Chiu, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei
State/Province
Wanhua Dist
ZIP/Postal Code
108306
Country
Taiwan

12. IPD Sharing Statement

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

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