Using mobile health data to improve recovery after bypass surgery for leg ischemia
ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
NA · University of Florida · NCT06263322
This study is testing if using health data from a smartwatch can help older patients recover better and move more easily after bypass surgery for leg problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 60 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06263322 on ClinicalTrials.gov |
What this trial studies
This pilot randomized clinical trial evaluates the impact of remotely collected patient-generated health data (PGHD) on the management of older patients undergoing bypass surgery for chronic limb-threatening ischemia. Participants will be randomized into two groups, one receiving integrated PGHD displayed on an electronic health record (EHR) system and the other receiving standard care with data stored but not displayed. The study aims to assess the feasibility of this approach in improving post-operative mobility and quality of life by monitoring symptoms through a smartwatch app. The trial will also focus on ensuring quality assurance and successful participant engagement throughout the study.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60 and above who are undergoing revascularization surgery for chronic limb-threatening ischemia.
Not a fit: Patients at high risk of post-surgical amputation or those with significant co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance post-surgical care and improve recovery outcomes for patients with chronic limb-threatening ischemia.
How similar studies have performed: Other studies have shown promise in using mobile health technologies for patient monitoring, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- Institute of Aging — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Todd Manini, PhD — University of Florida
- Study coordinator: Institute_on_Aging
- Email: recruit@aging.ufl.edu
- Phone: 352-273-5919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia