The ROAMM-EHR Study

Recruiting now · Not applicable

Conditions studied: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

In brief

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 facts

Study ID

NCT06263322

Run by

University of Florida

People needed

50

Starts

2023-11-16

Expected to finish

2026-10-17

Last updated by the study team

2025-06-27

Who can join

Age: 60 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Institute of Aging — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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