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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2026-07-31

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).

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Detailed Description

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Conditions

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Post-Intensive Care Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching

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.

Group Type EXPERIMENTAL

Health Coaching

Intervention Type BEHAVIORAL

Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.

Home-Based Program of Rehabilitation and Health Coaching

Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks.

Group Type EXPERIMENTAL

Home-based Physical Rehabilitation

Intervention Type BEHAVIORAL

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.

Health Coaching

Intervention Type BEHAVIORAL

Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.

Usual Care

Subjects will receive clinical standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based Physical Rehabilitation

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.

Intervention Type BEHAVIORAL

Health Coaching

Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No