Image

Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Recruiting
65 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 16-22
          5. Insurance with Traditional Medicare or Medicare Advantage
        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 at
             Baystate 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 precluding
             participation 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 details

Mobility Limitation, Frailty, Hospital Acquired Condition, Weakness, Muscle

NCT05725928

The Cleveland Clinic

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.