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NCT04986904 · ClinicalTrials.gov registry record · NA
Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers
A NA study of Insomnia and Sleep Initiation and Maintenance Disorders, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 2
- Study locations
NCT04986904: Completed NA study of Insomnia and Sleep Initiation and Maintenance Disorders, sponsored by University of Virginia.
NCT04986904 is a NA study of Insomnia and Sleep Initiation and Maintenance Disorders that has completed, run by University of Virginia. The registered enrollment target is 102 participants, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04986904, a NA study of Insomnia and Sleep Initiation and Maintenance Disorders, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 2
- Study locations
Study Summary
The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program. We will identify caregiving-related user- and environment characteristics that affect the use and impact of SHUTi, and other Internet interventions more broadly, for caregivers. We will recruit 100 high-intensity caregivers with insomnia to complete a baseline assessment of insomnia and caregiving context. Caregivers will then receive access to SHUTi in an open-label trial. At the end of the 9-week intervention period, caregivers will complete post-assessment and be categorized according to their level of engagement with the 6 SHUTi intervention lessons (or weekly "Cores"). We will test whether caregivers' engagement with SHUTi (i.e., being a non-user vs. incomplete user vs. complete user) is associated with their caregiving-related user characteristics (i.e., caregiving strain, self-efficacy, and guilt) and environment characteristics (i.e., proximity to care recipient; care recipient functional, cognitive, and behavioral status; caregiving tasks). Caregivers' barriers to and motivations for SHUTi engagement will be described from open-ended survey responses specific to participants' level of engagement as part of post-assessment. We will identify non-users' barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. We will also identify users' (incomplete and complete) SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. Thematic coding will also examine how caregivers' recommendations generalize t
Primary Outcome
Level of SHUTi engagement: Core completion (i.e., nonuser \[no cores completed\], incomplete user \[1-3 Cores\], or complete user \[4-6 Cores\])
Conditions Studied
Interventions
- BEHAVIORAL SHUTi (Sleep Healthy Using the Internet)
Study Locations (2)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-01-11 |
| Est. Completion | 2023-03-19 |
| Phase | NA |
What the finished NCT04986904 record still lists
NCT04986904 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (40% lower).
The record links to 3 conditions, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which SHUTi (Sleep Healthy Using the Internet) is the first listed.
NCT04986904 reports a single indexed study location in Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT04986904 about?
NCT04986904 is a clinical study titled "Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers". The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-deli...
What is the current status of trial NCT04986904?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2022-01-11. Estimated completion is 2023-03-19.
What conditions does trial NCT04986904 study?
This clinical trial studies the following conditions: Insomnia, Sleep Initiation and Maintenance Disorders, Family Caregivers.
What interventions are being tested in trial NCT04986904?
The interventions under investigation include: SHUTi (Sleep Healthy Using the Internet) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04986904?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04986904 being conducted?
This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04986904's enrollment target sits among peer trials
102 60th of 151 higher than 92 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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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