RecruitingNot ApplicableNCT06263322

The ROAMM-EHR Study

ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients

Sponsor

University of Florida

Enrollment

50 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease

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

Min Age: 60 YearsMax Age: 100 Years

Inclusion Criteria1

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

Exclusion Criteria1

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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Interventions

BEHAVIORALActionable 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

BEHAVIORALNon-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