Self-Management Behaviors of Caregivers of the Chronically Critically Ill

NCT03065829 | Completed DMC

• 2 other identifiers: 11-15-11P30NR015326
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

caregiver; chronically critically ill

Outcome Measures

Primary Outcomes (1)

• Repeated Measures

  ANCOVA Model (F-Statistic)

  Baseline to 30 days

Secondary Outcomes (7)

• Change in Active Living Protocol (captured on wearable device)

  From Baseline to up to 30 days

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

  From Baseline to up to 30 days

• Change in Perceived Stress Scale

  From Baseline to up to 30 days

• Change in PROMIS-29 Scale

  From Baseline to up to 30 days

• Change in Zarits Burden Interview

  From Baseline to up to 30 days

Study Arms (2)

ASSIST

EXPERIMENTAL

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

Attention-Control

EXPERIMENTAL

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

Interventions

ASSIST BEHAVIORAL

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

ASSIST

Attention-Control BEHAVIORAL

Wearable sensor technology only viewing biophysical sensor data.

Attention-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 32205788 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Ronald L. Hickman, PhD, RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 28, 2017
• Study Start: February 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

US (1)