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NCT03065829 · ClinicalTrials.gov registry record · NA
Self-Management Behaviors of Caregivers of the Chronically Critically Ill
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT03065829: Completed NA study, sponsored by Case Western Reserve University.
NCT03065829 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03065829, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
For family members of chronically critically ill (CCI) patients, an ICU admission marks a significant milestone in the patient's illness trajectory that highlights the onset of end of-life issues and an abrupt need for family members to assume the caregiver role for the first time. Assuming the caregiver role can have devastating and longstanding health consequences for family members, which can impair their ability to sustain caregiving behaviors for a CCI patient. The unrelenting psychological distress perceived by caregivers of CCI patients is linked to significant reductions in their self-management and health outcomes. The purpose of this study is to evaluate a theoretically-derived Adaptive SenSor-Based Intervention for Caregiver Self-ManagemenT (ASSIST) intervention compared to an attention control condition for first time caregivers of CCI patients discharged to an extended care facility. One group will be exposed to the ASSIST intervention and will wear the sensor-based technology for 30 days and receive a daily dose of MMT. Biophysical sensor data (blood pressure, heart-rate variability, pedometry, and actigraphy) will be continuously acquired and analyzed using anomaly detection and machine learning techniques to vary the dose intensity (number of doses per day) of the two components of ASSIST adding a real-time, adaptive feature to promote caregiver self-management. The other group will wear the sensor-based technology for 30 days but will not receive the daily dose of MMT. The investigators will randomly assign participants to each group.
Primary Outcome
ANCOVA Model (F-Statistic)
Interventions
- BEHAVIORAL Attention-Control
- BEHAVIORAL ASSIST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2016-02 |
| Est. Completion | 2017-07-31 |
| Phase | NA |
What the finished NCT03065829 record still lists
NCT03065829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Attention-Control is the first listed.
NCT03065829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03065829 about?
NCT03065829 is a clinical study titled "Self-Management Behaviors of Caregivers of the Chronically Critically Ill". For family members of chronically critically ill (CCI) patients, an ICU admission marks a significant milestone in the patient's illness trajectory that highlights the onset of end of-life issues and an abrupt need for family members to assume the caregiver role for the first time. Assuming the care...
What is the current status of trial NCT03065829?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2016-02. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT03065829?
The interventions under investigation include: Attention-Control (BEHAVIORAL), ASSIST (BEHAVIORAL).
Who is sponsoring clinical trial NCT03065829?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03065829's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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