Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06263322

Conditions

Peripheral Arterial Disease

Chronic Limb-Threatening Ischemia

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Actionable remotely generated health data

Non-Actionable remotely generated health data

Study Details

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.

Conditions

Peripheral Arterial Disease

Chronic Limb-Threatening Ischemia

Study ID

NCT06263322

Start date

Nov 16, 2023

Status verified date

Jun, 2025

Completion date

Oct 17, 2026

Anticipated

Primary completion date

Oct 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Actionable remotely generated health data

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

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 outcome measure

  • 6-min walk distance [ Time Frame: Baseline and approximately 30 days post-surgery ]

Central Contacts and Locations

Central contacts

Institute_on_Aging

352-273-5919recruit@aging.ufl.edu

HOBI department

(352) 627-9467hobi@health.ufl.edu

Locations

Institute of Aging

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Institute_of_Aging

352-273-5919recruit@aging.ufl.edu

HOBI_Department

352.627.9467hobi@health.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 27, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-06-27.