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Completed

NCT Number: NCT03065829

Self-Management Behaviors of Caregivers of the Chronically Critically Ill

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASSIST

Behavioral

Wearable sensor technology delivering mindfulness meditation training (MMT) and health promotion (sleep hygiene and physical activity) .

Attention-control

Behavioral

Wearable sensor technology only viewing biophysical sensor data.

Primary outcomes

  1. Repeated Measures

    Time frame: Baseline to 30 days

    ANCOVA Model (F-Statistic)

Secondary outcomes

  1. Change in Active Living Protocol (captured on wearable device)

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Sleep Activity

  2. Change in Daily Diary of Physical Activity (captured on wearable device)

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Physical Activity

  3. Change in Perceived Stress Scale

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Stress

  4. Change in PROMIS-29 Scale

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Anxiety and Depression

  5. Change in Zarits Burden Interview

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Burden

  6. Change in Health Behaviors Questionnaire

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Health Related Quality of Life

  7. Change in Heart Rate Variability (captured on wearable device)

    Time frame: From Baseline to up to 30 days

    Measure of Caregiver Heart Rate Variablity

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ASSIST

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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