StrokeNCT04744324
Self-supporting Care Model in Home Environment for Patients With Stroke
A study testing Self-supporting Care and Home health education in people with Stroke and Activities of Daily Living, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The purpose of this study was to administer intervention based on self-supporting care model in home environment and to explore the effects of this intervention on stroke patients' activities of daily living, movement, cognition, nutritional status, and quality of life. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Stroke, Activities of Daily Living
- What is being tested?
- Self-supporting Care and Home health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Mar 2021to 28 Feb 2023
- 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
- age > 20 years
- Diagnosis of stroke
- The modified Rankin Scale : 2~4
- Keep sitting for half an hour by himself/herself
- Follow instructions
- Willing to sign the subject's consent
Who cannot join
- Diagnosis of dementia
- History of orthopedic diseases or peripheral nerve injury
- readmission because of stroke
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Shihlin District, 111045
About this study
Official title: Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke
The purpose of this study was to administer intervention based on self-supporting care model in home environment and to explore the effects of this intervention on stroke patients' activities of daily living, movement, cognition, nutritional status, and quality of life.
Read the detailed description
Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 8 measures: Barthel Index-based Supplementary Scales, Canadian Occupational Performance Measure, Fugl-Meyer Assessment, Balance Computerized Adaptive Testing, Mini Mental State Examination-2nd edition, Mini Nutritional Assessment, Stroke Impact Scale, and Stroke Self-Efficacy Questionnaire.
- Conditions
- Stroke, Activities of Daily Living
- Being tested
- Self-supporting Care, Home health education
- Keywords
- Stroke, Self-supporting Care Model, Home Care Services
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-supporting CareBehavioural
Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)
Home health educationBehavioural
Individualized home health education
| Study group | Role | What they receive |
|---|---|---|
| Self-supporting Care Group | Experimental | Self-supporting Care in home Receives: Behavioral: Self-supporting Care |
| Control group | Active comparator | Home Health Education Receives: Behavioral: Home health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index -based Supplementary Scales
The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.
Measured: Baseline to 4 weeks
Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure is to measure occupational performance though three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance.
Measured: Baseline to 4 weeks
Fugl-Meyer Assessment
The Fugl-Meyer Assessment scale is to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.
Measured: Baseline to 4 weeks
Balance computerized adaptive testing
The Balance computerized adaptive testing is to assess balance ability.The score ranges is 0 to 10. A higher score indicates better balance ability.
Measured: Baseline to 4 weeks
Mini Mental State Examination-2nd edition
The Mini Mental State Examination-2nd edition is to assess cognitive functions. The score ranges is 0 to 90. A higher score indicates better cognitive functions.
Measured: Baseline to 4 weeks
Mini Nutritional Assessment
The Mini Nutritional Assessment is a comprehensive nutritional assessment scale. The score range is 0 to 30 points. The higher the score, the lower the risk of malnutrition.
Measured: Baseline to 4 weeks
Stroke Impact Scale
The Stroke Impact Scale is to assess health-related quality of life: emotion, communication, memory and thinking, and social role function. The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke.
Measured: Baseline to 4 weeks
Stroke Self-Efficacy Questionnaire
The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start3 Mar 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 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
- NCT04744324
- Sponsor's protocol ID
- SKH-20201006R
- Status last verified
- Apr 2023
- First submitted
- 3 Feb 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke
- ClinicalTrials.gov ID
- NCT04744324
- Acronym / sponsor ID
- SKH-20201006R
- Conditions
- Stroke, Activities of Daily Living
- Keywords
- Stroke, Self-supporting Care Model, Home Care Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Feb 2021 (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.
The purpose of this study was to administer intervention based on self-supporting care model in home environment and to explore the effects of this intervention on stroke patients' activities of daily living, movement, cognition, nutritional status, and quality of life.
Detailed description
Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 8 measures: Barthel Index-based Supplementary Scales, Canadian Occupational Performance Measure, Fugl-Meyer Assessment, Balance Computerized Adaptive Testing, Mini Mental State Examination-2nd edition, Mini Nutritional Assessment, Stroke Impact Scale, and Stroke Self-Efficacy Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-supporting Care Group | Experimental | Behavioral: Self-supporting CareSelf-supporting Care in home |
| Control group | Active comparator | Behavioral: Home health educationHome Health Education |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age > 20 years
- Diagnosis of stroke
- The modified Rankin Scale : 2~4
- Keep sitting for half an hour by himself/herself
- Follow instructions
Key exclusion criteria (3 listed)
- Diagnosis of dementia
- History of orthopedic diseases or peripheral nerve injury
- readmission because of stroke
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 |
|---|---|---|
| Self-supporting CareIndividualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition) | Behavioural | Self-supporting Care Group |
| Home health educationIndividualized home health education | Behavioural | Control group |
Primary outcome
Barthel Index -based Supplementary Scales
Time frame: Baseline to 4 weeks
The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.
Canadian Occupational Performance Measure
Time frame: Baseline to 4 weeks
The Canadian Occupational Performance Measure is to measure occupational performance though three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance.
Fugl-Meyer Assessment
Time frame: Baseline to 4 weeks
The Fugl-Meyer Assessment scale is to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.
Balance computerized adaptive testing
Time frame: Baseline to 4 weeks
The Balance computerized adaptive testing is to assess balance ability.The score ranges is 0 to 10. A higher score indicates better balance ability.
Mini Mental State Examination-2nd edition
Time frame: Baseline to 4 weeks
The Mini Mental State Examination-2nd edition is to assess cognitive functions. The score ranges is 0 to 90. A higher score indicates better cognitive functions.
Mini Nutritional Assessment
Time frame: Baseline to 4 weeks
The Mini Nutritional Assessment is a comprehensive nutritional assessment scale. The score range is 0 to 30 points. The higher the score, the lower the risk of malnutrition.
Stroke Impact Scale
Time frame: Baseline to 4 weeks
The Stroke Impact Scale is to assess health-related quality of life: emotion, communication, memory and thinking, and social role function. The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke.
Stroke Self-Efficacy Questionnaire
Time frame: Baseline to 4 weeks
The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.
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 10 Apr 2023.
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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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 Self-supporting Care and Home health education in people with Stroke and Activities of Daily Living, 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 6 inclusion and 3 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 10 Apr 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. 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?
Barthel Index -based Supplementary Scales (time frame: Baseline to 4 weeks). 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 10 Apr 2023.