Peripheral Arterial DiseaseROAMM-EHRNCT06263322
The ROAMM-EHR Study
A study testing Actionable remotely generated health data and Non-Actionable remotely generated health data in people with Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
- What is being tested?
- Actionable remotely generated health data and Non-Actionable remotely generated health data
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery [endovascular or open re-vascularization (bypass)].
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute of Aging
Gainesville, Florida, 32611
Institute_of_Aging, 352-273-5919, recruit@aging.ufl.edu
HOBI_Department, 352.627.9467, hobi@health.ufl.edu
About this study
Official title: ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
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.
Read the detailed description
This pilot study aims to evaluate the feasibility of collecting patient generated health data (PGHD) remotely for aiding care management of patients with chronic limb threatening ischemia following vascular bypass or revascularization. DRemote data collected from a publicly available smartwatch will be displayed on an EHR interface for providers to view PGHD. The test of feasibility entails multiple components that include implementing a provider interface for viewing and acting on PGHD, establishing safety, ensuring quality assurance (e.g. quality of remote data collection), successful recruitment and retention of participants, and sufficient remote response rates from patients.
- Being tested
- Actionable remotely generated health data, Non-Actionable remotely generated health data
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actionable remotely generated health dataBehavioural
Remotely 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 dataBehavioural
Remotely 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
| Study group | Role | What they receive |
|---|---|---|
| ROAMM-EHR | Experimental | 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. Receives: Behavioral: Actionable remotely generated health data |
| Active Comparison | Active comparator | 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. Receives: Behavioral: Non-Actionable remotely generated health data |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min walk distance
Patients are asked to complete as much distance as possible over a standardized course
Measured: Baseline and approximately 30 days post-surgery
Secondary 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)
Measured: Baseline and approximately 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start16 Nov 2023
- Primary completion17 Oct 2026 (estimated)
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Todd Manini, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263322
- Sponsor's protocol ID
- IRB202200419
- Other IDs
- R21AG073769
- Acronym
- ROAMM-EHR
- Status last verified
- Jun 2025
- First submitted
- 9 Feb 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study that tests feasibility. Collection of data for definitive testing purposes is not appropriate at this stage. If the study tests as feasible we will pursue data sharing under policies set forth by the local institution, privacy office and regulatory authorities. We will also follow any journal requirements for posting deidentified data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
- ClinicalTrials.gov ID
- NCT06263322
- Acronym / sponsor ID
- ROAMM-EHR / IRB202200419
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 17 Oct 2026 (estimated)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study aims to evaluate the feasibility of collecting patient generated health data (PGHD) remotely for aiding care management of patients with chronic limb threatening ischemia following vascular bypass or revascularization. DRemote data collected from a publicly available smartwatch will be displayed on an EHR interface for providers to view PGHD. The test of feasibility entails multiple components that include implementing a provider interface for viewing and acting on PGHD, establishing safety, ensuring quality assurance (e.g. quality of remote data collection), successful recruitment and retention of participants, and sufficient remote response rates from patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation.
| Arm | Type | Receives |
|---|---|---|
| ROAMM-EHR | Experimental | Behavioral: Actionable remotely generated health dataPatients 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. |
| Active Comparison | Active comparator | Behavioral: Non-Actionable remotely generated health dataThe 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery [endovascular or open re-vascularization (bypass)].
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actionable remotely generated health dataRemotely captured, patient generated health data will be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia | Behavioural | ROAMM-EHR |
| Non-Actionable remotely generated health dataRemotely 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 | Behavioural | Active Comparison |
Primary outcome
6-min walk distance
Time frame: Baseline and approximately 30 days post-surgery
Patients are asked to complete as much distance as possible over a standardized course
1 secondary outcome
self-reported quality of life
Time frame: Baseline and approximately 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No. This is a pilot study that tests feasibility. Collection of data for definitive testing purposes is not appropriate at this stage. If the study tests as feasible we will pursue data sharing under policies set forth by the local institution, privacy office and regulatory authorities. We will also follow any journal requirements for posting deidentified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Manini, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actionable remotely generated health data and Non-Actionable remotely generated health data in people with Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Institute_on_Aging (352-273-5919, recruit@aging.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk distance (time frame: Baseline and approximately 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.