- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07782047
Assistive Device Rental/Purchase, LTC Service Use, and Caregiver Burden in Taiwan
The Association Between Assistive Device Approval, Rental or Purchase Types, Long-Term Care Service Utilization, and Family Caregiver Burden in Taiwan: A Secondary Data Analysis of the Long-Term Care Service Database
The goal of this observational study is to examine the associations between assistive device approval and acquisition modality (rental or purchase), long-term care service utilization, and family caregiver burden among individuals receiving long-term care services in Taiwan. The study will use de-identified nationwide long-term care administrative data from 2021 to 2022.
The main questions it aims to answer are:
- What individual, disability-related, socioeconomic, residential, and caregiving factors are associated with assistive device approval, the number and type of approved devices, and rental or purchase modality?
- Are assistive device approval and utilization patterns associated with the use of formal long-term care services and with family caregiver burden?
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kai-Chia Cheng, PhD
- Phone Number: 51169 +886-5-6204000
- Email: kccheng@nhri.edu.tw
Study Contact Backup
- Name: Yu-Chi Chen, MS
- Phone Number: 51251 +886-5-6204000
- Email: irene.chen@nhri.edu.tw
Study Locations
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-
Yunlin County
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Huwei, Yunlin County, Taiwan, 632007
- National Center for Geriatrics and Welfare Research, National Health Research Institutes
-
Contact:
- Kai-Chia Cheng, PhD
- Phone Number: 51169 +886-5-6204000
- Email: kccheng@nhri.edu.tw
-
Contact:
- Yu-Chi Chen, MS
- Phone Number: 51251 +886-5-6204000
- Email: irene.chen@nhri.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals with a valid long-term care case record (CA100) in Taiwan's long-term care database between 2021 and 2022.
- Individuals with at least one valid assessment or care plan record (CA110) that can be linked to the corresponding CA100 record.
- Availability of interpretable key study variables, including individual and assessment/care plan identifiers, care plan status, and Case-Mix System (CMS) level or other core disability-related information.
- For analyses of assistive device utilization, the presence or absence of an assistive device record (QD113) and its approval status must be identifiable.
Exclusion Criteria:
- Records with missing key linkage variables that prevent establishment of relationships among individuals, care plans, assistive device records, or service utilization records.
- Records identified as invalid, cancelled, test records, or records whose validity cannot be determined.
- Records in which primary study variables cannot be interpreted.
- Records with clearly implausible values for variables such as individual age, caregiver age, CMS level, number of assistive devices, or service utilization that cannot be corrected according to prespecified data-cleaning rules.
- Records with inconsistent or contradictory date information that prevents valid determination of an index date or observation period.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Assistive device approved
Participants who was approved the assistive devise in nationwide long-term care administrative data in Taiwan
|
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No assistive device approved
Participants who was not approved the assistive devise in nationwide long-term care administrative data in Taiwan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assistive Device Approval Status
Time Frame: During the 2021-2022 observation period
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Whether an individual had an approved assistive device record, determined using the approval status recorded in the Assistive Technology File (QD113).
Associations with disability severity, sociodemographic characteristics, residential characteristics, and caregiving conditions will be examined.
|
During the 2021-2022 observation period
|
|
Formal Long-Term Care Service Utilization
Time Frame: During the 2021-2022 observation period
|
Utilization of formal long-term care services, including total service utilization and category-specific utilization of care services, professional services, transportation, respite care, meal services, and other long-term care services.
Associations with assistive device approval, number of devices, acquisition modality, and device category will be examined.
|
During the 2021-2022 observation period
|
|
Family Caregiver Burden
Time Frame: During the 2021-2022 observation period
|
Family caregiver burden will be assessed using available administrative-record indicators, including sleep disturbance, physical burden, competing caregiving demands, distress related to care-recipient behaviors, and inability to cope with caregiving stress.
A cumulative caregiver burden indicator will also be derived from the number of burden items endorsed.
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During the 2021-2022 observation period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assistive Device Acquisition Modality
Time Frame: During the 2021-2022 observation period
|
Acquisition modality of approved assistive devices, categorized as rental or purchase according to the Assistive Technology File (QD113) administrative record.
Factors associated with rental versus purchase will be examined.
|
During the 2021-2022 observation period
|
|
Number and Category of Approved Assistive Devices
Time Frame: During the 2021-2022 observation period
|
Number of approved assistive devices and device categories, such as mobility, transfer, bathing and toileting, home-care beds and bedside equipment, safety or monitoring devices, and communication or cognitive support devices.
|
During the 2021-2022 observation period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chueh-Ho Lin, PhD, National Health Research Institutes, Taiwan
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC1150701-E
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
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