The ROAMM-EHR Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorUniversity of Florida
About this trial
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
This trial does not accept healthy volunteersQualifiers
age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery [endovascular or open re-vascularization (bypass)].
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Actionable remotely generated health data
BehavioralRemotely 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 data
BehavioralRemotely 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ROAMM-EHRExperimental treatment 1 intervention
Group B: Active ComparisonActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-surgerySecondary outcomes
1
self-reported quality of life
Outcome will be assessed as the summary score on the Medical Outcomes Study 36-Item Short Form (SF-36)
Time frame
Baseline and approximately 30 days post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov