The ROAMM-EHR Study

Not Applicable

Recruiting

• Conditions: Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

• Registration Number: NCT06263322
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-11-16
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-16
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-10-17
• Study Completion: 2026-10-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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'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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-min walk distance	Baseline and approximately 30 days post-surgery	Patients are asked to complete as much distance as possible over a standardized course

Secondary Outcome Measures

Name	Time	Method
self-reported quality of life	Baseline and approximately 30 days post-surgery	Outcome will be assessed as the summary score on the Medical Outcomes Study 36-Item Short Form (SF-36)

Trial Locations

Locations (1)

Institute of Aging; 🇺🇸 Gainesville, Florida, United States