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Completed

NCT Number: NCT06184308

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

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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Key information

Conditions

Post-Intensive Care Syndrome postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Health Coaching

Behavioral

Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.

Primary outcomes

  1. Completion of home-based rehabilitation program

    Time frame: 12 weeks

    Total number of subjects to complete the home-based rehabilitation program per protocol

  2. 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

  1. Change in Anxiety and Depression

    Time frame: Baseline, 3 months

    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.

  2. Change in Post-Traumatic Stress Disorder (PTSD) Symptoms

    Time frame: Baseline, 3 months

    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.

  3. Change in cognition

    Time frame: Baseline, 3 months

    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.

  4. Change in Daily Steps

    Time frame: Baseline, 3 months

    Number of daily steps taken measured by wearable devices

  5. Change in Sedentary Time

    Time frame: Baseline, 3 months

    Total sedentary time in hours measured by wearable devices

  6. Change in Physical activity

    Time frame: Baseline, 3 months

    Total time recorded in in light, moderate, and strenuous physical activity in hours measured by wearable devices

  7. Change in Sleep time

    Time frame: Baseline, 3 months

    Total sleep time in hours measured by wearable devices

  8. Healthcare Utilization

    Time frame: 3 months

    Number of hospitalizations, outpatient, and ER visits

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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