Status:
RECRUITING
Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching
Lead Sponsor:
Mayo Clinic
Conditions:
Post-Intensive Care Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 sy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06184308
Start Date
May 8 2024
End Date
July 1 2026
Last Update
July 11 2025
Active Locations (2)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905