Actively Recruiting
ROAMM-EHR Pilot Trial of Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients with Chronic Limb Threatening Ischemia
Led by University of Florida · Updated on 2025-06-27
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of remotely collected patient generated health data (PGHD) from older adults undergoing bypass or re-vascular surgery for chronic limb threatening ischemia. This pilot randomized clinical trial aims to test whether integrating PGHD with electronic health record (EHR) systems helps providers better manage post-surgical symptoms and improve patients' mobility and quality of life after surgery. The study focuses on the feasibility and safety of this approach, as well as participant recruitment and retention. Participants will wear a smartwatch with an app before surgery and for about a month afterward, recording symptoms and health data daily while awake. The data will be sent electronically and displayed on a provider's EHR interface for one study group, allowing healthcare providers to use this information along with medical history to guide care decisions. A comparison group will also wear the watch and respond to questions, but their doctors will not see the data. All participants will continue to receive standard care. During the study, researchers will assess participants' walking ability using a 6-minute walk test at baseline and about 30 days post-surgery, along with self-reported quality of life measures. Providers will monitor the remotely collected data through the EHR interface, and participant safety and data quality will be evaluated. The total study duration includes pre-surgery and approximately one month post-surgery monitoring.
CONDITIONS
Brief Title
The ROAMM-EHR Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Diagnosis of chronic limb threatening ischemia
- Scheduled for re-vascular surgery, either endovascular or open bypass
You will not qualify if you...
- High risk of post-surgical amputation as judged by study physician
- Non-English speakers
- Diagnosis of age-related dementia such as Alzheimer's Disease
- Unable to communicate due to severe hearing loss
- Uncorrectable vision impairment affecting assessments or safety
- Other significant co-morbid diseases that impair participation or pose safety concerns as judged by investigators or study physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the day of surgery
Participants undergo re-vascular surgery for chronic limb threatening ischemia.
1 visit (in-person)
Duration - Approximately 1 month following surgery
Participants wear a smartwatch equipped with an app before surgery and for approximately one month after surgery. They respond to symptom questions daily while awake, and data is collected remotely to inform care management or observed without informing providers depending on the group assignment.
Daily use of smartwatch and symptom reporting
Duration - Around 30 days post-surgery
Participants complete assessments including a 6-minute walk test and self-reported quality of life approximately 30 days after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Institute of Aging
Gainesville, Florida, United States, 32611
Actively Recruiting
Research Team
I
Institute_on_Aging
H
HOBI department
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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