NCT04350775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

April 15, 2020

Last Update Submit

August 31, 2023

Conditions

Keywords

reablementinstrumental activities of daily living

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (2)

RE-IADL group

EXPERIMENTAL

Reablement

Other: RE-IADL

Control group

PLACEBO COMPARATOR

General community rehabilitation

Other: General community rehabilitation

Interventions

RE-IADLOTHER

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.

RE-IADL group

General community rehabilitation contains the activities in psychiatric rehabilitation center.

Control group

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersMental 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

April 15, 2020

First Posted

April 17, 2020

Study Start

November 30, 2021

Primary Completion

July 6, 2022

Study Completion

July 6, 2022

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations