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

Overview

About this study

The purpose of this study is to develop further and test the feasibility, safety, and efficacy of a home-based, nurse health coach-facilitated program of PR, physical activity and symptom monitoring, and comprehensive remote health coaching intervention that aims to improve health-related quality of life (HRQoL), daily physical activity,  Post ICU Syndrome (PICS) domain-specific impairments, caregiver burden, and healthcare utilization in PICS patients from hospitals with distinct location, diversity, and practice settings.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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; AND
  • 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Roberto Benzo, M.D.

Open for enrollment

Contact information:

Johanna Hoult M.A.

(507) 293-1989

Hoult.Johanna@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rodrigo Cartin-Ceba, M.D.

Open for enrollment

Contact information:

Johanna Hoult M.A.

(507) 293-1989

Hoult.Johanna@mayo.edu

More information

Publications

Publications are currently not available