ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 100
Healthy Volunteers: f
View:
• age \>= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery \[endovascular or open re-vascularization (bypass)\].
Locations
United States
Florida
Institute of Aging
RECRUITING
Gainesville
Contact Information
Primary
Institute_on_Aging
recruit@aging.ufl.edu
352-273-5919
Backup
HOBI department
hobi@health.ufl.edu
(352) 627-9467
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2026-10-17
Participants
Target number of participants: 50
Treatments
Experimental: ROAMM-EHR
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.
Active_comparator: Active 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.
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: National Institute on Aging (NIA)