Self-supporting Care Model in Home Environment for Patients With Stroke
Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2021
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedApril 10, 2023
April 1, 2023
2 years
February 3, 2021
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
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.
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.
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.
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.
Baseline to 4 weeks
Study Arms (2)
Self-supporting Care Group
EXPERIMENTALSelf-supporting Care in home
Control group
ACTIVE COMPARATORHome Health Education
Interventions
Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of dementia
- History of orthopedic diseases or peripheral nerve injury
- readmission because of stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Shihlin District, 111045, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
En-Chi Chiu, PhD
National Taipei University of Nursing and Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 3, 2021
First Posted
February 8, 2021
Study Start
March 3, 2021
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
April 10, 2023
Record last verified: 2023-04