The ROAMM-EHR Study

University of Florida

Status: Enrolling

Conditions: Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Treatments: Behavioral: Actionable remotely generated health data; Behavioral: Non-Actionable remotely generated health data

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06263322

R21AG073769 (U.S. NIH Grant/Contract)

IRB202200419

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

ROAMM-EHR

Experimental group

Description:

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:

Behavioral: Actionable remotely generated health data

Active Comparison

Active Comparator group

Description:

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:

Behavioral: Non-Actionable remotely generated health data