The ROAMM-EHR Study

NCT06263322 | Recruiting

• 2 other identifiers: IRB202200419R21AG073769
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 6-min walk distance

  Patients are asked to complete as much distance as possible over a standardized course

  Baseline and approximately 30 days post-surgery

Secondary Outcomes (1)

• self-reported quality of life

  Baseline and approximately 30 days post-surgery

Study Arms (2)

ROAMM-EHR

EXPERIMENTAL

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.

Behavioral: Actionable remotely generated health data

Active Comparison

ACTIVE COMPARATOR

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.

Behavioral: Non-Actionable remotely generated health data

Interventions

Actionable remotely generated health data BEHAVIORAL

Remotely captured, patient generated health data will be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia

ROAMM-EHR

Non-Actionable remotely generated health data BEHAVIORAL

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

Active Comparison

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery \[endovascular or open re-vascularization (bypass)\].

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Institute of Aging

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Todd Manini, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Institute_on_Aging

CONTACT

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

HOBI department

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: November 16, 2023
• Primary Completion (Estimated): October 17, 2026
• Study Completion (Estimated): October 17, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)