Self-Management Behaviors of Caregivers of the Chronically Critically Ill



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:7/12/2018
Start Date:February 2016
End Date:July 31, 2017

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The Mediating Effects of Decentering on Self-Management Behaviors in Caregivers of Critically Chronically Ill Patients

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.

The investigators will conduct a randomized controlled trial to examine the ASSIST
intervention compared to an attention control condition among 20 first time caregivers of CCI
patients discharged to an extended care facility. The investigators will collect mixed
methods data at baseline (T1) on Day 15 (T2) and Day 30 (T3) after subject enrollment to
describe changes in proximal and distal outcomes. We have chosen our time points to capture
neural and behavioral changes associated with the intervention.

The investigators aim to:

1. Determine whether there are differences in the distal outcomes [psychological burden
(anxiety, depression, caregiver burden, HRQoL), cardiovascular health (BP and HRV) and
economic costs] between subjects who were exposed to ASSIST compared to those exposed to
the attention control condition.

2. Examine whether decentering, self-efficacy, decision-making, motivation, caregiver
activation, and perceived stress mediate the relationship between exposure to a
self-management condition (ASSIST vs. attention control) and the proximal
(self-management) outcomes (stress reduction behaviors, sleep hygiene behaviors, and
physical activity).

3. Determine if social support and demographics (gender and age) moderate the proximal
outcomes [emotional distress, sleep quality, and physical activity] or distal outcomes
[psychological burden (anxiety, depression, caregiver burden, HRQoL), cardiovascular
health (BP and HRV) and economic costs].

4. Explore the differences in brain activation (structural and fMRI scans) and HPA function
and stress response (hair cortisol, inflammation panel) between subjects exposed to
ASSIST compared to those exposed to the attention control condition.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
Cleveland, Ohio 44194
Principal Investigator: Ronald L. Hickman, PhD, RN
Phone: 216-368-2147
?
mi
from
Cleveland, OH
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