NCT05260476

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

February 19, 2022

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Secondary Outcomes (5)

  • Barthel index, BI

    10 minutes

  • Instrumental Activities of Daily Living, IADL

    5 minutes

  • EuroQol Five Dimensions Questionnaire, EQ-5D

    5 minutes

  • Elderly Mobility Scale, EMS

    15 minutes

  • Handheld dynamometer to measure muscle strength

    5 minutes

Study Arms (2)

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

Other: Reablement

Non-reablement group

This group will only receive general home care service without the reablement program.

Other: Reablement

Interventions

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 groupReablement group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Using the outpatient rehabilitation service during the study period
  • Transferring or delivering to institution
  • Re-admission to hospital during using the service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jia-Ching Chen

    Department of physical therapy, Tzu Chi University

    PRINCIPAL INVESTIGATOR
  • Lian-Cing Yan

    Department of physical therapy, Tzu Chi University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
c123010@yahoo.com.tw

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 2, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share