Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Last updated: December 3, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Treatment

Mobility technician

Clinical Study ID

NCT05725928
22-426
1R01AG073278-01A1
  • Ages > 65
  • All Genders

Study Summary

The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to participate in this study:

  1. ≥65 years of age

  2. Admitted to a medical service

  3. Complete history and physical examination on file

  4. 6-Clicks score of 16-23

  5. Insurance with Traditional Medicare or Medicare Advantage

Exclusion

Exclusion Criteria:

Any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:

  1. Significant language barrier that requires a translator (other than Spanish atBaystate site only)

  2. Discharge planned for that day or the following day

  3. Observation status

  4. Surgical procedure planned

  5. Patients diagnosed with unstable angina or other medical conditions precludingparticipation in exercise/ambulation

  6. Permanent residence in a skilled nursing facility

  7. Comfort care measures only

  8. >48 hours since admission

  9. Active infection with COVID-19

  10. Other active infection requiring contact or droplet precautions

  11. Order for bedrest

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Mobility technician
Phase:
Study Start date:
May 15, 2023
Estimated Completion Date:
October 11, 2026

Study Description

The investigator proposes to conduct a large randomized trial to test the impact of MTs (Mobility Technicians) on short and intermediate term outcomes for 3000 patients aged 65 years and older at 5 hospitals in 2 health systems. Patients will be randomized to receive supervised ambulation up to 3 times daily with a MT or to receive usual care. All participants will wear an accelerometer on their wrist to track their movement throughout the hospital stay. The study has 3 aims. First, the study will compare the mobility of patients at discharge (or 10 days) to assess the impact of the MTs on this outcome. Of particular interest is whether the use of MTs will increase the proportion of patients who can go home vs.post-acute care, and whether the improvements in mobility are sustained at 30 days. Second, the study will use predictive modeling to identify which patients are most likely to benefit from this intervention. Third, the study will assess the impact of the intervention on overall costs associated with the episode of care, including inpatient costs and the 30 days post enrollment. This information will be important to convince health systems to adopt this approach.

Connect with a study center

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Active - Recruiting

  • Cleveland Clinic- Main Campus

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Marymount Hospital

    Garfield Heights, Ohio 44125
    United States

    Active - Recruiting

  • Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.