ASSIST: Self-Management Behaviors of Caregivers of the Chronically Critically Ill

Sponsor

Case Western Reserve University (Other)

Overall Status

Completed

CT.gov ID

NCT03065829

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arms

17.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Behavioral: ASSIST Behavioral: Attention-Control	N/A

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:

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.
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).
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].
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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Our model posits that effective caregiver self-management depends on analytic and emotional processing. The investigators hypothesize the ASSIST intervention will improve analytic processing by improving self-monitoring. ASSIST will expose subjects to mindfulness meditation training and promote self-awareness, which will aid the regulation of their emotional processing and improve proximal outcomes. The investigators expect proximal self-management outcomes to influence the distal outcomes of caregiver health. Our model will also test the mediating effects of decentering, processing, the hypothalamic-pituitary axis (HPA), inflammatory stress response, and cognitive mediators. The influence of potential moderators will be assessed for their effect on the relationship between the self-management intervention and the proximal and distal outcomes.Our model posits that effective caregiver self-management depends on analytic and emotional processing. The investigators hypothesize the ASSIST intervention will improve analytic processing by improving self-monitoring. ASSIST will expose subjects to mindfulness meditation training and promote self-awareness, which will aid the regulation of their emotional processing and improve proximal outcomes. The investigators expect proximal self-management outcomes to influence the distal outcomes of caregiver health. Our model will also test the mediating effects of decentering, processing, the hypothalamic-pituitary axis (HPA), inflammatory stress response, and cognitive mediators. The influence of potential moderators will be assessed for their effect on the relationship between the self-management intervention and the proximal and distal outcomes.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Jul 31, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Repeated Measures [Baseline to 30 days]
ANCOVA Model (F-Statistic)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

Case Western Reserve University
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)

Investigators

Principal Investigator: Ronald L. Hickman, PhD, RN, Case Western Reserve University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ronald Hickman, Associate Professor, Case Western Reserve University

ClinicalTrials.gov Identifier:

NCT03065829

Other Study ID Numbers:

11-15-11
P30NR015326

First Posted:

Feb 28, 2017

Last Update Posted:

Jul 10, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ronald Hickman, Associate Professor, Case Western Reserve University

caregiver

chronically critically ill

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Jul 10, 2018