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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching | Experimental | 5-10 subjects will be assigned to complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks to test feasibility of the home-based rehabilitation program. This will be the initial phase of the study prior to RCT phase. |
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| Home-Based Program of Rehabilitation and Health Coaching | Experimental | Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks. |
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| Usual Care | No Intervention | Subjects will receive clinical standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Physical Rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of home-based rehabilitation program | Total number of subjects to complete the home-based rehabilitation program per protocol | 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. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Post-Traumatic Stress Disorder (PTSD) Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Hoult | Contact | 507-293-1989 | Hoult.Johanna@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Cartin-Ceba, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| C000657744 | postintensive care syndrome |
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| Health Coaching | Behavioral | Study-trained nurse whom utilizes participant data to guide interactions in weekly calls. |
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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 |
| 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 |
| Change in Daily Steps | Number of daily steps taken measured by wearable devices | Baseline, 3 months |
| Change in Sedentary Time | Total sedentary time in hours measured by wearable devices | Baseline, 3 months |
| Change in Physical activity | Total time recorded in in light, moderate, and strenuous physical activity in hours measured by wearable devices | Baseline, 3 months |
| Change in Sleep time | Total sleep time in hours measured by wearable devices | Baseline, 3 months |
| Healthcare Utilization | Number of hospitalizations, outpatient, and ER visits | 3 months |
| Mayo Clinic Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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