NCT07782047

Brief Summary

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:

  1. 1.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?
  2. 2.Are assistive device approval and utilization patterns associated with the use of formal long-term care services and with family caregiver burden?

Trial Health

63
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Trial Health Score

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

Enrollment
161,771

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assistive Device Approval Status

    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

    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

    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.

    During the 2021-2022 observation period

Secondary Outcomes (2)

  • Assistive Device Acquisition Modality

    During the 2021-2022 observation period

  • Number and Category of Approved Assistive Devices

    During the 2021-2022 observation period

Study Arms (2)

Assistive device approved

Participants who was approved the assistive devise in nationwide long-term care administrative data in Taiwan

No assistive device approved

Participants who was not approved the assistive devise in nationwide long-term care administrative data in Taiwan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of individuals represented in Taiwan's nationwide long-term care administrative databases from 2021 to 2022. Eligible individuals must have a valid long-term care case record (CA100) and at least one valid linked assessment or care plan record (CA110). De-identified records will be used to examine assistive device approval and acquisition patterns, long-term care service utilization, and family caregiver-related characteristics and burden. No participants will be directly recruited or contacted.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Geriatrics and Welfare Research, National Health Research Institutes

Huwei, Yunlin County, 632007, Taiwan

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Chueh-Ho Lin, PhD

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Chia Cheng, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations