Self-Help DevicesNCT07782047
Assistive Device Rental/Purchase, LTC Service Use, and Caregiver Burden in Taiwan
An observational study of Self-Help Devices and Long-Term Care, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Self-Help Devices, Long-Term Care, Caregiver Burden
- How many people
- 161,771 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Center for Geriatrics and Welfare Research, National Health Research Institutes
Huwei, Yunlin County, 632007
Kai-Chia Cheng, PhD, +886-5-6204000 ext. 51169, kccheng@nhri.edu.tw
Yu-Chi Chen, MS, +886-5-6204000 ext. 51251, irene.chen@nhri.edu.tw
About this study
Official title: 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?
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During the 2021-2022 observation period
Secondary outcomes (2)
Assistive Device Acquisition Modality
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.
Measured: During the 2021-2022 observation period
Number and Category of Approved Assistive Devices
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.
Measured: During the 2021-2022 observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Help DevicesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161,771 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chueh-Ho Lin, PhD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782047
- Sponsor's protocol ID
- EC1150701-E
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07782047
- Acronym / sponsor ID
- EC1150701-E
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 161,771 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 24 Aug 2026 (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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assistive Device Approval Status
Time frame: During the 2021-2022 observation period
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.
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.
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.
2 secondary outcomes
Assistive Device Acquisition Modality
Time frame: During the 2021-2022 observation period
Number and Category of Approved Assistive Devices
Time frame: During the 2021-2022 observation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Chueh-Ho Lin, PhD principal investigator
National Health Research Institutes, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-Help Devices and Long-Term Care, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 5 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai-Chia Cheng, PhD (+886-5-6204000 ext. 51169, kccheng@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assistive Device Approval Status (time frame: During the 2021-2022 observation period). The study lists 3 primary outcomes in all. 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 24 Aug 2026.