Self-Management Behaviors of Caregivers of the Chronically Critically Ill (ASSIST)

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: ASSIST; Behavioral: Attention-Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ASSIST; The ASSIST intervention will deliver daily doses of MMT and vary dose intensity of all components each day based on the subject's biophysical data. Across a 30-day period, the ASSIST intervention will capture and analyze data to deliver on-demand MMT, guided practices to promote sleep hygiene and physical activity. Each day, subjects will receive at least one prompt to practice MMT (about 5 minutes at a time). However, based on the subject's biophysical sensor data, subjects could receive a maximum of 5 alerts or prompts per day from the device to enhance stress reduction, sleep hygiene, or physical activity.	Behavioral: ASSIST; Wearable sensor technology delivering mindfulness meditation training (MMT) and health promotion (sleep hygiene and physical activity) .
EXPERIMENTAL: Attention-Control; This intervention exposes subjects to the wearable technology without the self-management components to minimize novelty effects. Subjects assigned to this condition will wear the device for 30 days, which offers them an opportunity to experientially learn to self-monitor and employ self-regulatory skills by viewing the display biophysical data. Subjects in this condition will not receive any prompts from the device.	Behavioral: Attention-Control; Wearable sensor technology only viewing biophysical sensor data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeated Measures	ANCOVA Model (F-Statistic)	Baseline to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Active Living Protocol (captured on wearable device)	Measure of Caregiver Sleep Activity	From Baseline to up to 30 days
Change in Daily Diary of Physical Activity (captured on wearable device)	Measure of Caregiver Physical Activity	From Baseline to up to 30 days
Change in Perceived Stress Scale	Measure of Caregiver Stress	From Baseline to up to 30 days
Change in PROMIS-29 Scale	Measure of Caregiver Anxiety and Depression	From Baseline to up to 30 days
Change in Zarits Burden Interview	Measure of Caregiver Burden	From Baseline to up to 30 days
Change in Health Behaviors Questionnaire	Measure of Caregiver Health Related Quality of Life	From Baseline to up to 30 days
Change in Heart Rate Variability (captured on wearable device)	Measure of Caregiver Heart Rate Variablity	From Baseline to up to 30 days

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)

Publications and helpful links

General Publications

• Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): July 31, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (ACTUAL): February 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: caregiver; chronically critically ill
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 11-15-11; P30NR015326 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No