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.
This is a single-masked RCT pilot study design. The work leverages our existing mobile health
platform called Real-Time and Online Assessment and Mobility Monitor (ROAMM) to integrate
ecological PGHD with the UF Epic® EHR system. We will randomize 50 older adults (>=60 yrs) to
either ROAMM-EHR or an active comparison group. Importantly, both groups will receive
smartwatches with the ROAMM app. This removes the potential influence that interacting with a
smartwatch and reporting symptoms may have patient behaviors and post-surgical outcomes.
However, only data from the ROAMM-EHR group will be seen by physician teams; data from the
active comparison group will be stored but not displayed.
All participants will be prompted multiple times per day to report their symptoms (see table
2 for description), wound healing and any complications. Smartwatch sensors will capture
information about activity levels and community mobility via the location services (GPS).
Provider teams will be trained to use the EPIC interface that displays data from the ROAMM
app under the Technology Acceptance Model. They will be asked to do regular checks to monitor
patient's symptoms, complications and activity patterns.
Participants: We will enroll 50 older adult patients (age >=60 years) scheduled for vascular
bypass or revascularization. Patients will be randomized (stratified by gender) across
comparison groups. Eligibility criteria are as follows.
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;
We will evaluate whether ROAMM-EHR information impacts traditional clinically relevant
measures of lower extremity function and overall quality of life. We will measure the change
in 6-min walk distance at post-surgery (window: 30-50 days) versus pre-surgery. For the
self-reported quality of life, we chose the Medical Outcomes Study 36-Item Short Form (SF-36)
and modified Brief Pain Inventory.
We propose a total sample size of 50 participants - 2 randomized groups of 25. In pilot
studies, the goal is to have a sample size for estimating the margin of error that is
sufficiently small for planning future trials. With a conservative 10% loss to follow-up, the
margin of error in a 90% confidence interval will not exceed 12% of the point estimate in the
SF-36 physical composite score (1.88 points) or 6-min walk distance (22.9 meters). Thus, all
confidence interval widths are sufficiently small to plan future studies.