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

NCT ID: NCT04744324

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2023-02-28

Brief Summary

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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

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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

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Stroke Activities of Daily Living

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-supporting Care Group

Self-supporting Care in home

Group Type EXPERIMENTAL

Self-supporting Care

Intervention Type BEHAVIORAL

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

Control group

Home Health Education

Group Type ACTIVE_COMPARATOR

Home health education

Intervention Type BEHAVIORAL

Individualized home health education

Interventions

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Self-supporting Care

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

Intervention Type BEHAVIORAL

Home health education

Individualized home health education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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En-Chi Chiu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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En-Chi Chiu, PhD

Role: STUDY_DIRECTOR

National Taipei University of Nursing and Health Sciences

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Shihlin District, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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SKH-20201006R

Identifier Type: -

Identifier Source: org_study_id

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