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

NCT06184308 | Recruiting

• 1 other identifier: 23-006637
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Post-Intensive Care Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in Anxiety and Depression

  Baseline, 3 months

• Change in Post-Traumatic Stress Disorder (PTSD) Symptoms

  Baseline, 3 months

• Change in cognition

  Baseline, 3 months

• Change in Daily Steps

  Baseline, 3 months

• Change in Sedentary Time

  Baseline, 3 months

Study Arms (3)

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

EXPERIMENTAL

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

Home-Based Program of Rehabilitation and Health Coaching

EXPERIMENTAL

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

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

Usual Care

NO INTERVENTION

Subjects will receive clinical standard of care.

Interventions

Home-based Physical Rehabilitation 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.

Home-Based Program of Rehabilitation and Health Coaching

Health Coaching BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Rodrigo Cartin-Ceba, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Hoult

CONTACT

507-293-1989; Hoult.Johanna@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: May 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)