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NCT05465551 · ClinicalTrials.gov registry record · Early Phase 1
Stress Management Toolkit for People Living With Dementia and Their Care Partners
A Early Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 44
- Enrollment target
NCT05465551: Completed Early Phase 1 study, sponsored by Duke University.
NCT05465551 is a Early Phase 1 study that has completed, run by Duke University. The registered enrollment target is 44 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465551, a Early Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study. This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative
Primary Outcome
Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.
Interventions
- COMBINATION_PRODUCT Stress Management Toolkit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2025-01-06 |
| Phase | Early Phase 1 |
What the finished NCT05465551 record still lists
NCT05465551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which Stress Management Toolkit is the first listed.
NCT05465551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05465551 about?
NCT05465551 is a clinical study titled "Stress Management Toolkit for People Living With Dementia and Their Care Partners". The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. A human-centered design approach will be used to develop and user-test a prototype of a dy...
What is the current status of trial NCT05465551?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 44 participants. The study started on 2022-12-20. Estimated completion is 2025-01-06.
What interventions are being tested in trial NCT05465551?
The interventions under investigation include: Stress Management Toolkit (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05465551?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05465551's enrollment target sits among peer trials
44 589th of 2000 higher than 1,401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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