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Recruiting NCT06263322

The ROAMM-EHR Study

Trial Parameters

Condition Peripheral Arterial Disease
Sponsor University of Florida
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 60 Years
Max Age 100 Years
Start Date 2023-11-16
Completion 2026-10-17
Interventions
Actionable remotely generated health dataNon-Actionable remotely generated health data

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.

Eligibility Criteria

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

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