SchizophreniaNCT04503954
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
A study testing Chronic disease self-management program and General psychiatric intervention in people with Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Chronic disease self-management program and General psychiatric intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Sep 2020to 25 Dec 2020
- 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 was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.
Read the detailed description
Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.
- Conditions
- Schizophrenia
- Being tested
- Chronic disease self-management program, General psychiatric intervention
- Keywords
- chronic disease self-management program
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic disease self-management programOther
The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.
General psychiatric interventionOther
General psychiatric intervention contains the activities in psychiatric center.
| Study group | Role | What they receive |
|---|---|---|
| Self-management group | Experimental | Self-management group Chronic disease self-management program is conduct training skills, person how to live together with personal chronic disease to make life quality better. Receives: Other: Chronic disease self-management program |
| Control group | Placebo comparator | Control group will continue general psychiatric intervention. Receives: Other: General psychiatric intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stanford Self-Management Questionnaire
The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Beck Depression Inventory-II,
Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression.
Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Activities of Daily Living Rating Scale III,
Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Instrumental Activities of Daily Living
Instrumental Activities of Daily Living assesses instrumental activities of daily living.
A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Participation Measure-3 Domains Domains, 4 Dimensions
Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Work Behavior Inventory
Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Schizophrenia-Quality of Life questionnaire
Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Mini Mental State Examination-2nd edition
Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function.
Changes of Mini Mental State Examination will be assessed at the 0 week, 6 weeks.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start7 Sep 2020
- Primary completion25 Dec 2020
- Study completion25 Dec 2020
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
- NCT04503954
- Sponsor's protocol ID
- TCHIRB-10904004
- Status last verified
- Nov 2021
- First submitted
- 5 Aug 2020
- Last updated
- 16 Nov 2021
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT04503954
- Acronym / sponsor ID
- TCHIRB-10904004
- Conditions
- Schizophrenia
- Keywords
- chronic disease self-management program
- 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
- 7 Sep 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 7 Aug 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 was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.
Detailed description
Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management group | Experimental | Other: Chronic disease self-management programSelf-management group Chronic disease self-management program is conduct training skills, person how to live together with personal chronic disease to make life quality better. |
| Control group | Placebo comparator | Other: General psychiatric interventionControl group will continue general psychiatric intervention. |
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 |
|---|---|---|
| Chronic disease self-management programThe chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease. | Other | Self-management group |
| General psychiatric interventionGeneral psychiatric intervention contains the activities in psychiatric center. | Other | Control group |
Primary outcome
Stanford Self-Management Questionnaire
Time frame: 6 week
The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.
Beck Depression Inventory-II,
Time frame: 6 week
Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression. Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.
Activities of Daily Living Rating Scale III,
Time frame: 6 week
Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.
Instrumental Activities of Daily Living
Time frame: 6 week
Instrumental Activities of Daily Living assesses instrumental activities of daily living. A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.
Participation Measure-3 Domains Domains, 4 Dimensions
Time frame: 6 week
Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.
Work Behavior Inventory
Time frame: 6 week
Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.
Schizophrenia-Quality of Life questionnaire
Time frame: 6 week
Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.
Mini Mental State Examination-2nd edition
Time frame: 6 week
Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function. Changes of Mini Mental State Examination will be assessed at the 0 week, 6 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 16 Nov 2021.
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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 Chronic disease self-management program and General psychiatric intervention 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 16 Nov 2021. 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?
Stanford Self-Management Questionnaire (time frame: 6 week). The study lists 8 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 16 Nov 2021.