Self-Management Behaviors of Caregivers of the Chronically Critically Ill

Completed · Not applicable

Conditions studied: Critical Illness

In brief

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.

Key facts

Study ID

NCT03065829

Run by

Case Western Reserve University

People needed

19

Starts

2016-02-01

Expected to finish

2017-07-31

Last updated by the study team

2018-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• aged 18 years or older
• recognized as the family member who will assume the caregiver role for a critically ill adult requiring at least 72 hours of mechanical ventilation and scheduled for a discharge to an extended care facility
• speak and comprehend English

You may not qualify if…

• currently practicing mindfulness-based interventions
• require psychotherapy or required psychotherapy within the last three months
• have a history of dementia or major neurological illness
• pregnant
• history of medical conditions or procedures that is contraindicated for fMRI scanning
• claustrophobia requiring anxiolytics or sedation
• expected to relocate from Northeast Ohio within two months

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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