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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04350775
Collaborator
(none)
80
1
2
20
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: RE-IADL
  • Other: General community rehabilitation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes of the Canadian Occupational Performance Measure [18 weeks]

    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.

  2. Changes of the Instrumental Activities of Daily Living-3 Dimensions [18 weeks]

    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.

  3. Changes of the Activities of Daily Living Rating Scale III [18 weeks]

    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.

  4. Changes of the Frenchay Activity Index [18 weeks]

    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.

  5. Changes of the Lawton Instrumental Activities of Daily Living [18 weeks]

    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.

  6. Changes of the Mini Mental State Examination-2nd edition [18 weeks]

    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.

  7. Changes of the Behavior Rating Inventory of Executive Function adult version [18 weeks]

    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.

  8. Changes of the Allen Cognitive Level Screen-6th [18 weeks]

    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.

  9. Changes of the Participation Measure-3 Domains, 4 Dimensions [18 weeks]

    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.

  10. Changes of the Personal and Social Performance scale [18 weeks]

    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.

  11. Changes of the Work Behavior Inventory [18 weeks]

    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.

  12. Changes of the Schizophrenia-Quality of Life questionnaire [18 weeks]

    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.

  13. Changes of the Beck Depression Inventory-II [18 weeks]

    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.

  14. Changes of the Functioning Scale of the Disability Evaluation System [18 weeks]

    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.

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:
NCT04350775
Other Study ID Numbers:
  • TCHIRB-10812015
First Posted:
Apr 17, 2020
Last Update Posted:
Dec 6, 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2021