SchizophreniaNCT04350775
Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia
A study testing RE-IADL and General community rehabilitation in people with Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- RE-IADL and General community rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2021to 6 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia by DSM-5
- age > 20 years
- Stable mental symptoms
- Willing to sign the subject's consent
Who cannot join
- History of severe brain injury
- Substance abuse
- Diagnosis of intellectual developmental disorder
- Unable to follow instructions
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, Wanhua Dist, 108306
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- RE-IADL, General community rehabilitation
- Keywords
- reablement, instrumental activities of daily living
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
General community rehabilitationOther
General community rehabilitation contains the activities in psychiatric rehabilitation center.
| Study group | Role | What they receive |
|---|---|---|
| RE-IADL group | Experimental | Reablement Receives: Other: RE-IADL |
| Control group | Placebo comparator | General community rehabilitation Receives: Other: General community rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start30 Nov 2021
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, En-Chi Chiu, National Taipei University of Nursing and Health Sciences
- Investigators
- En-Chi Chiu, PhD, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350775
- Sponsor's protocol ID
- TCHIRB-10812015
- Status last verified
- Aug 2023
- First submitted
- 15 Apr 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Community Reablement on Instrumental Activities of Daily Living in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT04350775
- Acronym / sponsor ID
- TCHIRB-10812015
- Conditions
- Schizophrenia
- Keywords
- reablement, instrumental activities of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RE-IADL group | Experimental | Other: RE-IADLReablement |
| Control group | Placebo comparator | Other: General community rehabilitationGeneral community rehabilitation |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia by DSM-5
- age > 20 years
- Stable mental symptoms
- Willing to sign the subject's consent
Key exclusion criteria (4 listed)
- History of severe brain injury
- Substance abuse
- Diagnosis of intellectual developmental disorder
- Unable to follow instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RE-IADLRE-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. | Other | RE-IADL group |
| General community rehabilitationGeneral community rehabilitation contains the activities in psychiatric rehabilitation center. | Other | Control group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
En-Chi Chiu, PhD study director
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RE-IADL and General community rehabilitation in people with Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the Canadian Occupational Performance Measure (time frame: 18 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.