NCT06184308 Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching
| NCT ID | NCT06184308 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Post-Intensive Care Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2024-05-08 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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.
Contact & Investigator
Rodrigo Cartin-Ceba, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06184308 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Intensive Care Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06184308 currently recruiting?
Yes, NCT06184308 is actively recruiting participants. Contact the research team at Hoult.Johanna@mayo.edu for enrollment information.
Where is the NCT06184308 trial being conducted?
This trial is being conducted at Scottsdale, United States, Rochester, United States.
Who is sponsoring the NCT06184308 clinical trial?
NCT06184308 is sponsored by Mayo Clinic. The principal investigator is Rodrigo Cartin-Ceba, MD at Mayo Clinic. The trial plans to enroll 220 participants.