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Behavioral Intervention

Mobile App Health Data Collection for Peripheral Arterial Disease (ROAMM-EHR Trial)

N/A

Recruiting

Led By Todd Manini, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with chronic limb threatening ischemia undergoing re-vascular surgery (endovascular or open re-vascularization (bypass))

Age greater than or equal to 60

Must not have

Diagnosis of an age-related dementia (e.g. Alzheimer's Disease)

Unable to communicate because of severe hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and approximately 30 days post-surgery

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if using a mobile app to collect health data from older patients undergoing bypass surgery can help doctors better manage post-surgical symptoms and improve mobility and quality of life."

Who is the study for?

This trial is for individuals aged 60 or older with chronic limb-threatening ischemia who are undergoing bypass surgery. It's not suitable for those at high risk of post-surgical amputation, non-English speakers, dementia patients, those with severe hearing loss or vision impairment that affects assessments and safety, or other serious diseases as judged by the study physician.

What is being tested?

The ROAMM-EHR Study tests if patient health data collected remotely can help manage symptoms after bypass surgery for critical limb ischemia. Participants will either receive actionable health data alerts integrated with their EHR system or non-actionable information to compare outcomes.

What are the potential side effects?

Since this trial involves monitoring via mHealth apps rather than drugs or invasive procedures, typical medication side effects aren't expected. However, there may be privacy concerns related to personal health data management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am undergoing surgery to improve blood flow in my limbs due to severe blockage.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a dementia related to aging, like Alzheimer's.

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I have severe hearing loss that prevents me from communicating.

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My vision problems cannot be fixed and may affect my safety or health checks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and approximately 30 days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and approximately 30 days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and approximately 30 days post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-min walk distance

Secondary study objectives

self-reported quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ROAMM-EHRExperimental Treatment1 Intervention

Patients will wear a smartwatch equipped with a smartwatch app before their surgery and for approximately a month after the surgery. Patients will be asked to wear the watch every day when awake. When wearing the smartwatch, patients will be asked questions about their symptoms following surgery and data will be sent to providers electronically and displayed in their EHR portal. Healthcare Providers will use this information along with patient medical history to decide on the next course of action. The study does not provide specific instructions about how to care for the patient. Those decisions are made by the provider team and their clinical judgement.

Group II: Active ComparisonActive Control1 Intervention

The active comparison patients will wear and respond to questions on the smartwatch. However, the information will not be viewable by their doctor and medical team. All standard of care procedures will remain.

0 / 5Eligibility criteria met