Using mobile health data to improve recovery after bypass surgery for leg ischemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.