Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching

Post-Intensive Care Syndrome Clinical Trial

Official title:

Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184308
• Other study ID #: 23-006637
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Johanna Hoult
• Phone: 507-293-1989
• Email: Hoult.Johanna[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-Intensive Care Syndrome
• Syndrome

Intervention

Behavioral:
• Home-based Physical Rehabilitation
Six out of seven days a week, gentle flexibility practice (upper arm and shoulder movements) that can be done seated or standing and two slow walking sessions focused on balance. In addition, complete a breathing practice focused on breathing in through the nose and exhaling through the mouth.
• Health Coaching
Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of home-based rehabilitation program	Total number of subjects to complete the home-based rehabilitation program per protocol	12 weeks
Primary	Change in health related quality of life	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.	Baseline, 3 months
Secondary	Change in Anxiety and Depression	Measured using the Hospital Anxiety and Depression Scale (HADS) assessing subjects feelings in the past week. Total score 0-21 with 0-7 = normal, 8-10 borderline abnormal; and 11-21 abnormal.	Baseline, 3 months
Secondary	Change in Post-Traumatic Stress Disorder (PTSD) Symptoms	Measured using the Impact of Events Scale-Revised (IES-R) to assess subjective distressing difficulties experienced in the past seven days after a specific stressful event. 22 questions with total scoring range of 0 to 88 with 24 or more indicating PTSD is a clinical concern; 33 and above represents probable diagnosis of PTSD; and 37 or more high enough to suppress immune system's functioning.	Baseline, 3 months
Secondary	Change in cognition	Measured by the Healthy Aging Brain Care (HABC)-Monitor self-reported version questionnaire to assess brain health using a scale of not all (0-1 day); several days (2-6 days); more than half the days (7-11 days); and almost daily (12-14 days). Total score range of 0 to 81 with higher scores indicating poor cognitive, functional and behavioral brain health.	Baseline, 3 months
Secondary	Change in Daily Steps	Number of daily steps taken measured by wearable devices	Baseline, 3 months
Secondary	Change in Sedentary Time	Total sedentary time in hours measured by wearable devices	Baseline, 3 months
Secondary	Change in Physical activity	Total time recorded in in light, moderate, and strenuous physical activity in hours measured by wearable devices	Baseline, 3 months
Secondary	Change in Sleep time	Total sleep time in hours measured by wearable devices	Baseline, 3 months
Secondary	Healthcare Utilization	Number of hospitalizations, outpatient, and ER visits	3 months