Clinical trial NCT06184308: Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching
Official title: Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Intensive Care Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Completion of home-based rehabilitation program
timeFrame: 12 weeks
measure: Change in health related quality of life
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Anxiety and Depression
timeFrame: Baseline, 3 months
measure: Change in Post-Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: Baseline, 3 months
measure: Change in cognition
timeFrame: Baseline, 3 months
measure: Change in Daily Steps
timeFrame: Baseline, 3 months
measure: Change in Sedentary Time
timeFrame: Baseline, 3 months
measure: Change in Physical activity
timeFrame: Baseline, 3 months
measure: Change in Sleep time
timeFrame: Baseline, 3 months
measure: Healthcare Utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rodrigo Cartin-Ceba, MD
role: PRINCIPAL_INVESTIGATOR
References: