Home-based rehabilitation and health coaching for post-intensive care syndrome
Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients
NA · Mayo Clinic · NCT06184308
This study is testing a home-based rehab program with health coaching to see if it helps adults who have been in the ICU and are dealing with post-intensive care syndrome feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT06184308 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a home-based rehabilitation program combined with health coaching for patients suffering from post-intensive care syndrome (PICS). PICS can occur after prolonged stays in the ICU, leading to new or worsening symptoms that can persist long after discharge. The intervention aims to improve patient outcomes through tailored physical rehabilitation and supportive health coaching. Participants will be adults who have experienced significant ICU stays and meet specific inclusion criteria related to their medical history.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been admitted to the ICU for more than 48 hours and exhibit symptoms of PICS.
Not a fit: Patients with severe uncontrolled psychological disorders or those receiving hospice or palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and recovery outcomes for patients suffering from PICS.
How similar studies have performed: Other studies have shown promise in using home-based rehabilitation and coaching for recovery, suggesting this approach could be effective for PICS as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (RECRUITING)
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Rodrigo Cartin-Ceba, MD — Mayo Clinic
- Study coordinator: Johanna Hoult
- Email: Hoult.Johanna@mayo.edu
- Phone: 507-293-1989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-Intensive Care Syndrome