ReablementNCT05260476
The Effect of Reablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People
An observational study of Reablement and Home Rehabilitation, run by Buddhist Tzu Chi General Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Reablement, Home Rehabilitation
- What is being tested?
- Reablement
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Using the outpatient rehabilitation service during the study period
- Transferring or delivering to institution
- Re-admission to hospital during using the service
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Reablement, Home Rehabilitation
- Being tested
- Reablement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReablementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Reablement | |
| Non-reablement group | This group will only receive general home care service without the reablement program. Receives: Other: Reablement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery, SPPB
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.
Measured: 15 minutes
Secondary outcomes (5)
Barthel index, BI
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.
Measured: 10 minutes
Instrumental Activities of Daily Living, IADL
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.
Measured: 5 minutes
EuroQol Five Dimensions Questionnaire, EQ-5D
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.
Measured: 5 minutes
Elderly Mobility Scale, EMS
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.
Measured: 15 minutes
Handheld dynamometer to measure muscle strength
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReablementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-Ching Chen, Tzu Chi University
- Investigators
- Jia-Ching Chen, Principal investigator, Department of physical therapy, Tzu Chi UniversityLian-Cing Yan, Study director, Department of physical therapy, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260476
- Sponsor's protocol ID
- IRB110-277-B
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect of Rreablement Service of Long-term Care on Physical Mobility and Quality of Life in Disable People
- ClinicalTrials.gov ID
- NCT05260476
- Acronym / sponsor ID
- IRB110-277-B
- Conditions
- Reablement, Home Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reablement group | – | Other: ReablementThe 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 |
| Non-reablement group | – | Other: ReablementThis group will only receive general home care service without the reablement program. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Using the outpatient rehabilitation service during the study period
- Transferring or delivering to institution
- Re-admission to hospital during using the service
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReablementThe 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. | Other | Non-reablement group, Reablement group |
Primary outcome
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.
5 secondary outcomes
Barthel index, BI
Time frame: 10 minutes
Instrumental Activities of Daily Living, IADL
Time frame: 5 minutes
EuroQol Five Dimensions Questionnaire, EQ-5D
Time frame: 5 minutes
Elderly Mobility Scale, EMS
Time frame: 15 minutes
Handheld dynamometer to measure muscle strength
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Reablement
Recruiting
Effectiveness of Implementing a Reablement Model in Community-Based Long-Term Care Centers
Elderly, Long-Term Care
Active, not recruiting
Reablement Intervention for Older Adults in Day Care Centers
Reablement, Elderly
Recruiting
ASSIST 2.0: a Reablement Program for Healthy Ageing
Reablement, Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia-Ching Chen principal investigator
Department of physical therapy, Tzu Chi University
Lian-Cing Yan study director
Department of physical therapy, Tzu Chi University
Questions about this trial
What is this clinical trial studying?
An observational study of Reablement and Home Rehabilitation, run by Buddhist Tzu Chi General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-Ching Chen (886-3-8565301 ext. 2493, chenjiaching0608@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery, SPPB (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.