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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 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 19 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03065829
The ClinicalTrials.gov registry entry for NCT03065829 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Attention-Control is the first listed.
NCT03065829 reports 0 study locations.
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.
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