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

Mayo Clinic

Status: Enrolling

Conditions: Post-Intensive Care Syndrome

Treatments: Behavioral: Home-based Physical Rehabilitation; Behavioral: Health Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT06184308

23-006637

Details and patient eligibility

About

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).

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Health Coaching

Home-Based Program of Rehabilitation and Health Coaching

Experimental group

Description:

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

Treatment:

Behavioral: Health Coaching

Behavioral: Home-based Physical Rehabilitation

Usual Care

No Intervention group

Description:

Subjects will receive clinical standard of care.