Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263322
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-09
Brief Title:
The ROAMM-EHR Study
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
ROAMM-EHR Pilot Trial of a Real-Time Symptom Surveillance System for Post-Discharge Surgical Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROAMM-EHR
Brief 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 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 eg quality of remote data collection successful recruitment and retention of participants and sufficient remote response rates from patients
This is a single-masked RCT pilot study design The work leverages our existing mobile health platform called Real-Time and Online Assessment and Mobility Monitor ROAMM to integrate ecological PGHD with the UF Epic EHR system We will randomize 50 older adults 60 yrs to either ROAMM-EHR or an active comparison group Importantly both groups will receive smartwatches with the ROAMM app This removes the potential influence that interacting with a smartwatch and reporting symptoms may have patient behaviors and post-surgical outcomes However only data from the ROAMM-EHR group will be seen by physician teams data from the active comparison group will be stored but not displayed
All participants will be prompted multiple times per day to report their symptoms see table 2 for description wound healing and any complications Smartwatch sensors will capture information about activity levels and community mobility via the location services GPS Provider teams will be trained to use the EPIC interface that displays data from the ROAMM app under the Technology Acceptance Model They will be asked to do regular checks to monitor patients symptoms complications and activity patterns
Participants We will enroll 50 older adult patients age 60 years scheduled for vascular bypass or revascularization Patients will be randomized stratified by gender across comparison groups Eligibility criteria are as follows
Inclusion criteria age 60 Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery endovascular or open re-vascularization bypass
Exclusion criteria High risk of post-surgical amputation based on study physician judgement non-english speaker diagnosis of an age-related dementia eg Alzheimers 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
We will evaluate whether ROAMM-EHR information impacts traditional clinically relevant measures of lower extremity function and overall quality of life We will measure the change in 6-min walk distance at post-surgery window 30-50 days versus pre-surgery For the self-reported quality of life we chose the Medical Outcomes Study 36-Item Short Form SF-36 and modified Brief Pain Inventory
We propose a total sample size of 50 participants - 2 randomized groups of 25 In pilot studies the goal is to have a sample size for estimating the margin of error that is sufficiently small for planning future trials With a conservative 10 loss to follow-up the margin of error in a 90 confidence interval will not exceed 12 of the point estimate in the SF-36 physical composite score 188 points or 6-min walk distance 229 meters Thus all confidence interval widths are sufficiently small to plan future studies
This is a single-masked RCT pilot study design The work leverages our existing mobile health platform called Real-Time and Online Assessment and Mobility Monitor ROAMM to integrate ecological PGHD with the UF Epic EHR system We will randomize 50 older adults 60 yrs to either ROAMM-EHR or an active comparison group Importantly both groups will receive smartwatches with the ROAMM app This removes the potential influence that interacting with a smartwatch and reporting symptoms may have patient behaviors and post-surgical outcomes However only data from the ROAMM-EHR group will be seen by physician teams data from the active comparison group will be stored but not displayed
All participants will be prompted multiple times per day to report their symptoms see table 2 for description wound healing and any complications Smartwatch sensors will capture information about activity levels and community mobility via the location services GPS Provider teams will be trained to use the EPIC interface that displays data from the ROAMM app under the Technology Acceptance Model They will be asked to do regular checks to monitor patients symptoms complications and activity patterns
Participants We will enroll 50 older adult patients age 60 years scheduled for vascular bypass or revascularization Patients will be randomized stratified by gender across comparison groups Eligibility criteria are as follows
Inclusion criteria age 60 Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery endovascular or open re-vascularization bypass
Exclusion criteria High risk of post-surgical amputation based on study physician judgement non-english speaker diagnosis of an age-related dementia eg Alzheimers 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
We will evaluate whether ROAMM-EHR information impacts traditional clinically relevant measures of lower extremity function and overall quality of life We will measure the change in 6-min walk distance at post-surgery window 30-50 days versus pre-surgery For the self-reported quality of life we chose the Medical Outcomes Study 36-Item Short Form SF-36 and modified Brief Pain Inventory
We propose a total sample size of 50 participants - 2 randomized groups of 25 In pilot studies the goal is to have a sample size for estimating the margin of error that is sufficiently small for planning future trials With a conservative 10 loss to follow-up the margin of error in a 90 confidence interval will not exceed 12 of the point estimate in the SF-36 physical composite score 188 points or 6-min walk distance 229 meters Thus all confidence interval widths are sufficiently small to plan future studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AG073769 | NIH | None | httpsreporternihgovquickSearchR21AG073769 |