NCT04744324

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

February 3, 2021

Last Update Submit

April 6, 2023

Conditions

Keywords

StrokeSelf-supporting Care ModelHome Care Services

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

EXPERIMENTAL

Self-supporting Care in home

Behavioral: Self-supporting Care

Control group

ACTIVE COMPARATOR

Home Health Education

Behavioral: Home health education

Interventions

Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)

Self-supporting Care Group

Individualized home health education

Control group

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • En-Chi Chiu, PhD

    National Taipei University of Nursing and Health Sciences

    STUDY DIRECTOR

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

Locations