Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Part of paid clinical trials in Springfield, Massachusetts.

Sponsor
The Cleveland Clinic
Study ID
NCT05725928
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

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

Interventions

  • Mobility technician — BEHAVIORAL
    Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session.

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
Jun 2026
Primary completion
Nov 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Usual Care
    No intervention
  • Experimental: Mobility Technician
    Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session

Primary Outcome Measure

Change in Short Physical Performance Battery (SPPB) from admission [ Time Frame: Up to 10 days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Baystate Medical CenterSpringfieldMassachusetts01199
Quinn Pack, MD
[email protected]
413-794-7137
Cleveland Clinic- Main CampusClevelandOhio44195
Michael Rothberg, MD
[email protected]
216-445-0719
Fairview HospitalClevelandOhio44111
Michael Rothberg, MD
[email protected]
216-445-0719
Marymount HospitalGarfield HeightsOhio44125
Michael Rothberg, MD
[email protected]
216-445-0719
Hillcrest HospitalMayfield HeightsOhio44124
Aaron Hamilton, MD
[email protected]
440 312-3000

Find similar trials in Springfield, MA

By research site
Baystate Medical Center· Springfield, MACleveland Clinic- Main Campus· Cleveland, OHFairview Hospital· Cleveland, OHMarymount Hospital· Garfield Heights, OHHillcrest Hospital· Mayfield Heights, OH

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