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NCT Number: NCT06263322

The ROAMM-EHR Study

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.

Recruiting

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Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 6-min walk distance

    Time frame: Baseline and approximately 30 days post-surgery

    Patients are asked to complete as much distance as possible over a standardized course

Secondary outcomes

  1. self-reported quality of life

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

HOBI department

CONTACT

[email protected]

(352) 627-9467

Institute_on_Aging

CONTACT

[email protected]

352-273-5919

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients

Acronym: ROAMM-EHR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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