Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching

Study Overview
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Brief Summary
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The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).

Official Title
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Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients

Conditions
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Post-Intensive Care Syndrome

Intervention / Treatment
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* Behavioral: Home-based Physical Rehabilitation
* Behavioral: Health Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age ≥ 18) with PICS defined as admitted to the ICU for more than 48 hours with any of the following conditions: respiratory failure of any cause requiring mechanical ventilation ≥ three days, any shock requiring vasopressors and/or inotropes, development of delirium during the ICU stay, , and cardiac arrest during the index hospital admission. A HABC-M-SR score > 12 points. Exclusion Criteria: Any mechanical ventilation in the last two months before the index ICU admission ≥ 5 days in the ICU over the previous month before the index ICU admission Receiving hospice or palliative care Severe uncontrolled psychological or psychiatric disorders, e.g., schizophrenia, bipolar disorder, struggling to cope as a result of their personality disorder, uncontrolled substance abuse (alcoholism, illegal drugs) homelessness would make them unsuitable for the intervention A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control, e.g., progressive cancer, anoxic brain injury, severe rheumatoid arthritis or osteoarthritis, multiple sclerosis, chronic widespread pain syndrome, previous cerebral vascular event that the patient would not be able to participate in PR Patients with moderate/severe cognitive impairment per medical records screening Inability to obtain informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching<br>5-10 subjects will be assigned to complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks to test feasibility of the home-based rehabilitation program. This will be the initial phase of the study prior to RCT phase. | Behavioral: Health Coaching<br>* Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.<br>|
| Experimental: Home-Based Program of Rehabilitation and Health Coaching<br>Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks. | Behavioral: Home-based Physical Rehabilitation<br>* Six out of seven days a week, gentle flexibility practice (upper arm and shoulder movements) that can be done seated or standing and two slow walking sessions focused on balance. In addition, complete a breathing practice focused on breathing in through the nose and exhaling through the mouth.<br>Behavioral: Health Coaching<br>* Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.<br>|
| No Intervention: Usual Care<br>Subjects will receive clinical standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of home-based rehabilitation program | Total number of subjects to complete the home-based rehabilitation program per protocol | 12 weeks | 
| Change in health related quality of life | Measured by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score. Questionnaire assess 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a 5 level severity scale of no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems. | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety and Depression | Measured using the Hospital Anxiety and Depression Scale (HADS) assessing subjects feelings in the past week. Total score 0-21 with 0-7 = normal, 8-10 borderline abnormal; and 11-21 abnormal. | Baseline, 3 months | 
| Change in Post-Traumatic Stress Disorder (PTSD) Symptoms | Measured using the Impact of Events Scale-Revised (IES-R) to assess subjective distressing difficulties experienced in the past seven days after a specific stressful event. 22 questions with total scoring range of 0 to 88 with 24 or more indicating PTSD is a clinical concern; 33 and above represents probable diagnosis of PTSD; and 37 or more high enough to suppress immune system's functioning. | Baseline, 3 months | 
| Change in cognition | Measured by the Healthy Aging Brain Care (HABC)-Monitor self-reported version questionnaire to assess brain health using a scale of not all (0-1 day); several days (2-6 days); more than half the days (7-11 days); and almost daily (12-14 days). Total score range of 0 to 81 with higher scores indicating poor cognitive, functional and behavioral brain health. | Baseline, 3 months | 
| Change in Daily Steps | Number of daily steps taken measured by wearable devices | Baseline, 3 months | 
| Change in Sedentary Time | Total sedentary time in hours measured by wearable devices | Baseline, 3 months | 
| Change in Physical activity | Total time recorded in in light, moderate, and strenuous physical activity in hours measured by wearable devices | Baseline, 3 months | 
| Change in Sleep time | Total sleep time in hours measured by wearable devices | Baseline, 3 months | 
| Healthcare Utilization | Number of hospitalizations, outpatient, and ER visits | 3 months |