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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG073769 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actionable remotely generated health data | Behavioral | Remotely captured, patient generated health data will be used to inform provider care following re-vascular surgery in patients with chronic limb threatening ischemia |
| Measure | Description | Time Frame |
|---|---|---|
| 6-min walk distance | Patients are asked to complete as much distance as possible over a standardized course | Baseline and approximately 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| self-reported quality of life | Outcome will be assessed as the summary score on the Medical Outcomes Study 36-Item Short Form (SF-36) | Baseline and approximately 30 days post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Institute_on_Aging | Contact | 352-273-5919 | recruit@aging.ufl.edu | |
| HOBI department | Contact | (352) 627-9467 | hobi@health.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Todd Manini, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Aging | Recruiting | Gainesville | Florida | 32611 | United States |
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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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation.
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Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider.
| Non-Actionable remotely generated health data | Behavioral | 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 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |