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

August 31, 2023 updated by: En-Chi Chiu, National Taipei University of Nursing and Health Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Wanhua Dist
      • Taipei, Wanhua Dist, Taiwan, 108306
        • National Taipei University of Nursing and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of the Canadian Occupational Performance Measure
Time Frame: 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.
18 weeks
Changes of the Instrumental Activities of Daily Living-3 Dimensions
Time Frame: 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.
18 weeks
Changes of the Activities of Daily Living Rating Scale III
Time Frame: 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.
18 weeks
Changes of the Frenchay Activity Index
Time Frame: 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.
18 weeks
Changes of the Lawton Instrumental Activities of Daily Living
Time Frame: 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.
18 weeks
Changes of the Mini Mental State Examination-2nd edition
Time Frame: 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.
18 weeks
Changes of the Behavior Rating Inventory of Executive Function adult version
Time Frame: 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.
18 weeks
Changes of the Allen Cognitive Level Screen-6th
Time Frame: 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.
18 weeks
Changes of the Participation Measure-3 Domains, 4 Dimensions
Time Frame: 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.
18 weeks
Changes of the Personal and Social Performance scale
Time Frame: 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.
18 weeks
Changes of the Work Behavior Inventory
Time Frame: 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.
18 weeks
Changes of the Schizophrenia-Quality of Life questionnaire
Time Frame: 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.
18 weeks
Changes of the Beck Depression Inventory-II
Time Frame: 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.
18 weeks
Changes of the Functioning Scale of the Disability Evaluation System
Time Frame: 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.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taipei University of Nursing and Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: En-Chi Chiu, PhD, National Taipei University of Nursing and Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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