search
Back to results

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

Primary Purpose

Stroke, Activities of Daily Living

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-supporting Care
Home health education
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Self-supporting Care Model, Home Care Services

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-supporting Care Group

Control group

Arm Description

Self-supporting Care in home

Home Health Education

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2021
Last Updated
April 6, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04744324
Brief Title
Self-supporting Care Model in Home Environment for Patients With Stroke
Official Title
Effects of Self-supporting Care Model on Activities of Daily Living for Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Activities of Daily Living
Keywords
Stroke, Self-supporting Care Model, Home Care Services

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-supporting Care Group
Arm Type
Experimental
Arm Description
Self-supporting Care in home
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Home Health Education
Intervention Type
Behavioral
Intervention Name(s)
Self-supporting Care
Intervention Description
Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)
Intervention Type
Behavioral
Intervention Name(s)
Home health education
Intervention Description
Individualized home health education
Primary Outcome Measure Information:
Title
Barthel Index -based Supplementary Scales
Description
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.
Time Frame
Baseline to 4 weeks
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
Baseline to 4 weeks
Title
Fugl-Meyer Assessment
Description
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.
Time Frame
Baseline to 4 weeks
Title
Balance computerized adaptive testing
Description
The Balance computerized adaptive testing is to assess balance ability.The score ranges is 0 to 10. A higher score indicates better balance ability.
Time Frame
Baseline to 4 weeks
Title
Mini Mental State Examination-2nd edition
Description
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.
Time Frame
Baseline to 4 weeks
Title
Mini Nutritional Assessment
Description
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.
Time Frame
Baseline to 4 weeks
Title
Stroke Impact Scale
Description
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.
Time Frame
Baseline to 4 weeks
Title
Stroke Self-Efficacy Questionnaire
Description
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.
Time Frame
Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Chi Chiu, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei City
State/Province
Shihlin District
ZIP/Postal Code
111045
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs