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Behavioral Intervention

ROAMM-EHR 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and approximately 30 days post-surgery

Awards & highlights

ROAMM-EHR Trial 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.Check my eligibility

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.See study design

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.

ROAMM-EHR Trial 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.

ROAMM-EHR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6-min walk distance

Secondary outcome measures

self-reported quality of life

ROAMM-EHR 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,596 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

188 Patients Enrolled for Peripheral Arterial Disease

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,835 Total Patients Enrolled

20 Trials studying Peripheral Arterial Disease

16,545 Patients Enrolled for Peripheral Arterial Disease

Todd Manini, PhDPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

92 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this clinical investigation?

"The details on clinicaltrials.gov indicate that this study is actively seeking participants. It was initially posted on November 16, 2023, and last revised on February 9, 2024. The trial aims to enroll 50 individuals from a single site."

Answered by AI

Do individuals aged 60 and above meet the criteria for participation in this study?

"Participants eligible for this trial must be aged between 60 and 100 years old. There are a total of 30 studies focusing on individuals under 18, while there are 555 trials dedicated to those over the age of 65."

Answered by AI

Are patients currently being actively recruited for participation in this study?

"Indeed, data from clinicaltrials.gov confirms that this trial is presently seeking participants. The study was first listed on November 16th, 2023 and most recently revised on February 9th, 2024. A total of 50 individuals are sought for enrollment at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The ROAMM-EHR Study

2023. "The ROAMM-EHR Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263322.

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