[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536322":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":9,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Actionable remotely generated health data",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Non-Actionable remotely generated health data",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Actionable remotely generated health data","Remotely captured, patient generated health data will be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non-Actionable remotely generated health data","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",[15],[32],{"name":33,"affiliation":5,"role":34},"Todd Manini, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Institute_on_Aging","CONTACT","352-273-5919","recruit@aging.ufl.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"HOBI department","(352) 627-9467","hobi@health.ufl.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Institute of Aging","RECRUITING","Gainesville","Florida","32611","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-82.32483,29.65163,{"lat":58,"lon":57},[61,63],{"name":62,"role":38,"phone":39,"phoneExt":26,"email":40},"Institute_of_Aging",{"name":64,"role":38,"phone":65,"phoneExt":26,"email":44},"HOBI_Department","352.627.9467",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[69],{"name":70,"class":71},"National Institute on Aging (NIA)","NIH","100536322","the-roamm-ehr-study-100536322",false,"NCT06263322","The ROAMM-EHR Study","ROAMM-EHR: Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients","Inclusion Criteria:\n\n* age \\>= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery \\[endovascular or open re-vascularization (bypass)\\].\n\nExclusion Criteria:\n\n* 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","ALL","60 Years","100 Years",{"count":83,"type":84},50,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.",[90,91],"Peripheral Arterial Disease","Chronic Limb-Threatening Ischemia","2025-06-24",{"date":94,"type":95},"2025-06-27","ACTUAL",{"date":97,"type":95},"2023-11-16",{"date":99,"type":84},"2026-10-17",{"name":5,"class":6},1]