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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06184308
Status
Recruiting
Apply to this trial

Conditions

  • Post-Intensive Care Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
May 8, 2024
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching
    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.
  • Experimental: Home-Based Program of Rehabilitation and Health Coaching
    Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks.
  • No Intervention: Usual Care
    Subjects will receive clinical standard of care.

Primary Outcome Measure

Completion of home-based rehabilitation program [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Rodrigo Cartin-Ceba, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic MinnesotaRochesterMinnesota55905
Roberto Benzo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic Arizona· Scottsdale, AZMayo Clinic Minnesota· Rochester, MN

Related Studies