Self-Management Behaviors of Caregivers of the Chronically Critically Ill
Public ClinicalTrials.gov record NCT03065829. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Mediating Effects of Decentering on Self-Management Behaviors in Caregivers of Critically Chronically Ill Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03065829
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2016
- Primary completion
- Jul 30, 2017
- Completion
- Jul 30, 2017
- Last update posted
- Jul 9, 2018
2016 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03065829, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03065829 live on ClinicalTrials.gov.