Tracking symptoms at home after leg bypass surgery for poor blood flow
Tests phone-based symptom tracking after bypass surgery in older people with chronic limb-threatening ischemia.
Key facts
- Who runs it
- University of Florida
- Where
- Gainesville, United StatesSee the site
- Trial code
- Registry title
- The ROAMM-EHR Study
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 16 Nov 2023
- Planned end
- 17 Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Actionable remotely generated health data
- Non-Actionable remotely generated health data
- Record updated
- 27 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 60 or older with chronic limb threatening ischemia (very poor blood flow to the legs) who are having surgery to restore blood flow. Participants wear a smartwatch that asks about symptoms after surgery.
- Age
- 60 Years to 100 Years
- Sex
- All sexes can join.
- Disease stage
- Chronic limb threatening ischemia, with planned surgery to restore blood flow (endovascular or open bypass surgery).
Main reasons for not taking part
- High risk of amputation after surgery, as judged by the study doctor
- Does not speak English
- Diagnosis of age-related dementia, such as Alzheimer's Disease
- Cannot communicate because of severe hearing loss, or has vision problems that cannot be corrected
- Other serious illness that would make taking part hard or unsafe, in the doctors' opinion
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery [endovascular or open re-vascularization (bypass)]
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 100 years old?
Where in United States
- Institute of AgingGainesville, United StatesContact: Institute_of_AgingTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ROAMM-EHRTreatment being tested
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.
Treatment: Actionable remotely generated health data
- Active ComparisonExisting treatment, for 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.
Treatment: Non-Actionable remotely generated health data
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
- Plain-language title
- Tracking symptoms at home after leg bypass surgery for poor blood flowGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06263322, who can take part
- Record updated
- 27 June 2025