The ROAMM-EHR Study

Last updated: June 24, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Circulation Disorders

Claudication

Treatment

Actionable remotely generated health data

Non-Actionable remotely generated health data

Clinical Study ID

NCT06263322
IRB202200419
R21AG073769
  • Ages 60-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age >= 60; Patients with chronic limb threatening ischemia who are undergoingre-vascular surgery [endovascular or open re-vascularization (bypass)].

Exclusion

Exclusion Criteria:

  • High risk of post-surgical amputation based on study physician judgement,non-english speaker, diagnosis of an age-related dementia (e.g. Alzheimer'sDisease); unable to communicate because of severe hearing loss; uncorrectable visionimpairment that compromises clinical assessments or would cause a safety concern,other significant co-morbid disease that in the opinion of the investigators andstudy physician would impair the ability to participate in the study or be a safetyconcern

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Actionable remotely generated health data
Phase:
Study Start date:
November 16, 2023
Estimated Completion Date:
October 17, 2026

Study Description

This pilot study aims to evaluate the feasibility of collecting patient generated health data (PGHD) remotely for aiding care management of patients with chronic limb threatening ischemia following vascular bypass or revascularization. DRemote data collected from a publicly available smartwatch will be displayed on an EHR interface for providers to view PGHD. The test of feasibility entails multiple components that include implementing a provider interface for viewing and acting on PGHD, establishing safety, ensuring quality assurance (e.g. quality of remote data collection), successful recruitment and retention of participants, and sufficient remote response rates from patients.

Connect with a study center

  • Institute of Aging

    Gainesville, Florida 32611
    United States

    Active - Recruiting

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