Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post-Intensive Care Syndrome
- Sponsor
- Mayo Clinic
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Completion of home-based rehabilitation program
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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).
Investigators
Rodrigo Cartin-Ceba
Principal Investigator
Mayo Clinic
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.
Outcomes
Primary Outcomes
Completion of home-based rehabilitation program
Time Frame: 12 weeks
Total number of subjects to complete the home-based rehabilitation program per protocol
Change in health related quality of life
Time Frame: Baseline, 3 months
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.
Secondary Outcomes
- 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)
- Change in Sleep time(Baseline, 3 months)
- Change in Physical activity(Baseline, 3 months)
- Healthcare Utilization(3 months)