The ROAMM-EHR Study

University of Florida50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Actionable remotely generated health dataBEHAVIORAL

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 dataBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

6-min walk distance

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

Time frame: Baseline and approximately 30 days post-surgery

Secondary Outcomes

self-reported quality of life

Outcome will be assessed as the summary score on the Medical Outcomes Study 36-Item Short Form (SF-36)