The ROAMM-EHR Study

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06263322
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Limb-Threatening Ischemia
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
60 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Actionable remotely generated health data — BEHAVIORAL
    Remotely captured, patient generated health data will be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia
  • Non-Actionable remotely generated health data — BEHAVIORAL
    Remotely captured, patient generated health data is captured, but will not be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia

Study Details

In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes.

Key Dates

Start date
Nov 16, 2023
Status verified
Jun 2025
Primary completion
Oct 17, 2026
Completion
Oct 17, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ROAMM-EHR
    Patients will wear a smartwatch equipped with a smartwatch app before their surgery and for approximately a month after the surgery. Patients will be asked to wear the watch every day when awake. When wearing the smartwatch, patients will be asked questions about their symptoms following surgery and data will be sent to providers electronically and displayed in their EHR portal. Healthcare Providers will use this information along with patient medical history to decide on the next course of action. The study does not provide specific instructions about how to care for the patient. Those decisions are made by the provider team and their clinical judgement.
  • Active Comparator: Active Comparison
    The active comparison patients will wear and respond to questions on the smartwatch. However, the information will not be viewable by their doctor and medical team. All standard of care procedures will remain.

Primary Outcome Measure

6-min walk distance [ Time Frame: Baseline and approximately 30 days post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute of AgingGainesvilleFlorida32611
Institute_of_Aging
[email protected]
352-273-5919
HOBI_Department
[email protected]
352.627.9467

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Institute of Aging· Gainesville, FL

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