- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05260476
The Effect of Reablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People
To Investigate the Effect of Rreablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People
The long-term care 2.0 policy has been launched at 2017 by Taiwanese government to respond the rate of aging population reached to14% and estimated to 20% in 2025, becoming a "super-aged society" in Taiwan. As aging society, the ratio of chronic disease and disability has reasonably raised. The home reablement and care of this policy are not only to prevent and delay disability but provide daily care for the elderly who needed. As the implementation of the policy, there is still insufficient research to investigate and compare the effects on physical mobility and quality of life among the individual after using these different types of the service. Therefore, the aim of the study is to compare the effects on physical function and quality of life of the frail and disabled individual with and without receiving the home reablement services.
The participants will be enrolled from the long-term care service units registered in local government at Hualien county, Taiwan. The recruited participants will be assigned to two groups in a convenient method (receiving and non-receiving the home reablement service). All participants will be assessed by a professional physical therapist at three time points, before the reablement, at 1-3 months after receiving the reablement, then follow-up after 3 months
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jia-Ching Chen
- Phone Number: 2493 886-3-8565301
- Email: chenjiaching0608@gmail.com
Study Contact Backup
- Name: Lian-Cing Yan
- Phone Number: 2493 886-3-8565301
- Email: 110331102@gms.tcu.edu.tw
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Aged from 50-90 years old
- The disability grade level 2 to 8 according to the grading with long-term care case-mix system, approximately to 20 to 80 of Barthel Index score.
Description
Inclusion Criteria:
- Aged from 50-90 years old
- Be able to follow the command and cooperate with the assessor
- The disability grade level 2 to 8 according to the grading with long-term care case-mix system, approximately to 20 to 80 of Barthel Index score.
- Receiving the reablement services at least 3 times/a set.
Exclusion Criteria:
- Using the outpatient rehabilitation service during the study period
- Transferring or delivering to institution
- Re-admission to hospital during using the service
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Reablement group
The home reablement program will be implemented by a physical therapist according to "Long-term Care Reablement Operational Guidelines" announced by the Ministry of Health and Welfare of Taiwanese government
|
The service provider customizes a training plan and formulates training goals based on the patient's level of disability, family environment, and the needs of the patient and the caregiver.
|
|
Non-reablement group
This group will only receive general home care service without the reablement program.
|
The service provider customizes a training plan and formulates training goals based on the patient's level of disability, family environment, and the needs of the patient and the caregiver.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery, SPPB
Time Frame: 15 minutes
|
The SPPB is one of the most commonly used instruments for measuring physical performance in population studies of aging.
The SPPB consists of three subtests: a hierarchical test of balance, a short walk at usual pace and standing up from a chair five times consecutively.
Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barthel index, BI
Time Frame: 10 minutes
|
The total score is from 0 to 100, each item is divided into 2-4 levels according to complete independence, need assistance and complete dependence.
The lower the score, the higher the dependent level.
|
10 minutes
|
|
Instrumental Activities of Daily Living, IADL
Time Frame: 5 minutes
|
There are eight domains of function measured with the Lawton IADL scale.
Evaluators are scored according to their highest level of functioning in that category.
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
|
5 minutes
|
|
EuroQol Five Dimensions Questionnaire, EQ-5D
Time Frame: 5 minutes
|
The quality of life was assessed using 5 items: Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression.
This questionnaire asks respondents to choose the option that best suits them based on their health status.
|
5 minutes
|
|
Elderly Mobility Scale, EMS
Time Frame: 15 minutes
|
The EMS is a 7-item objective measure designed to assess mobility and function in elderly adults.
Divided into bedside mobility and functional mobility (lying to sitting, sitting to lying, standing, and balance and walking).
The total score is 0 to 20 points.
The higher the score, the better performance.
|
15 minutes
|
|
Handheld dynamometer to measure muscle strength
Time Frame: 5 minutes
|
Grip strength will be measured twice on the left and right sides of the elderly in a standard sitting position with elbow 90 degree and shoulder in neutral position, and the average value will be taken.
|
5 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jia-Ching Chen, Department of physical therapy, Tzu Chi University
- Study Director: Lian-Cing Yan, Department of physical therapy, Tzu Chi University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB110-277-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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