RecruitingNot ApplicableNCT06184308

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

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


Sponsor

Mayo Clinic

Enrollment

220 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria7

  • 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.

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Interventions

BEHAVIORALHome-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.

BEHAVIORALHealth Coaching

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


Locations(2)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Mayo Clinic Minnesota

Rochester, Minnesota, United States

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NCT06184308


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