Self-supporting Care Model in Home Environment for Patients With Stroke

Stroke Clinical Trial

Official title:

Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744324
• Other study ID #: SKH-20201006R
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diagnosis of dementia

• History of orthopedic diseases or peripheral nerve injury

• readmission because of stroke

Related Conditions & MeSH terms

• Activities of Daily Living
• Stroke

Intervention

Behavioral:
• Self-supporting Care
Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)
• Home health education
Individualized home health education

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei City	Shihlin District

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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