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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 is a Early Phase 1 study that has completed, run by Duke University. The registered enrollment target is 44 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05465551
The ClinicalTrials.gov registry entry for NCT05465551 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Stress Management Toolkit is the first listed.
NCT05465551 reports 0 study locations.
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.
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