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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
220
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.
Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
RECRUITINGMayo Clinic Minnesota
Rochester, Minnesota, United States
RECRUITINGCompletion of home-based rehabilitation program
Total number of subjects to complete the home-based rehabilitation program per protocol
Time frame: 12 weeks
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.
Time frame: Baseline, 3 months
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.
Time frame: Baseline, 3 months
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.
Time frame: Baseline, 3 months
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.
Time frame: Baseline, 3 months
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Change in Daily Steps
Number of daily steps taken measured by wearable devices
Time frame: Baseline, 3 months
Change in Sedentary Time
Total sedentary time in hours measured by wearable devices
Time frame: Baseline, 3 months
Change in Physical activity
Total time recorded in in light, moderate, and strenuous physical activity in hours measured by wearable devices
Time frame: Baseline, 3 months
Change in Sleep time
Total sleep time in hours measured by wearable devices
Time frame: Baseline, 3 months
Healthcare Utilization
Number of hospitalizations, outpatient, and ER visits
Time frame: 3 months