Self-Management Behaviors of Caregivers of the Chronically Critically Ill

Critical Illness Clinical Trial

— ASSIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065829
• Other study ID #: 11-15-11
• Secondary ID: P30NR015326
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: July 2018
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Behavioral:
• ASSIST
Wearable sensor technology delivering mindfulness meditation training (MMT) and health promotion (sleep hygiene and physical activity) .
• Attention-Control
Wearable sensor technology only viewing biophysical sensor data.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeated Measures	ANCOVA Model (F-Statistic)	Baseline to 30 days
Secondary	Change in Active Living Protocol (captured on wearable device)	Measure of Caregiver Sleep Activity	From Baseline to up to 30 days
Secondary	Change in Daily Diary of Physical Activity (captured on wearable device)	Measure of Caregiver Physical Activity	From Baseline to up to 30 days
Secondary	Change in Perceived Stress Scale	Measure of Caregiver Stress	From Baseline to up to 30 days
Secondary	Change in PROMIS-29 Scale	Measure of Caregiver Anxiety and Depression	From Baseline to up to 30 days
Secondary	Change in Zarits Burden Interview	Measure of Caregiver Burden	From Baseline to up to 30 days
Secondary	Change in Health Behaviors Questionnaire	Measure of Caregiver Health Related Quality of Life	From Baseline to up to 30 days
Secondary	Change in Heart Rate Variability (captured on wearable device)	Measure of Caregiver Heart Rate Variablity	From Baseline to up to 30 days