Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-04 @ 11:57 PM
Study NCT ID:
NCT04107935
Status:
TERMINATED
Last Update Posted:
2023-12-18
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telemedicine for Reach, Education, Access and Treatment-ongoing
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Telemedicine for Reach, Education, Access and Treatment-ongoing
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID-19 pandemic, we were unable to meet our recruitment goal during the grant period.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAT-ON
Brief Summary:
Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are scarce. Therefore, study investigators propose addressing these issues by implementing a model of care that includes diabetes educator (DE)-led planned visits with a real-time videoconferencing telemedicine program for ongoing patient support to improve DM outcomes.
Detailed Description:
Health care systems need to seek ways through quality improvement, care coordination, and workforce capacity to support quality care. It has been proposed that new models of care coupled with technology are needed. DM provides an ideal model for testing new approaches as the number of people with DM continues to rise, with an inverse shortage of health providers available to meet their needs. Most patients with Type 2 DM (T2DM) are seen in primary care (PC) where providers report barriers to comprehensive care that include limited time, educational resources, added workload and feeling ill-equipped to counsel patients on behavior change. Efforts to restructure PC are underway, like DE-led planned management visits, reported to improve healthy behaviors and outcomes in patients at high risk. DEs are well suited to support the skills, decision making, self-care behaviors, problem solving and active collaboration with the care team that serve as the foundation for diabetes self-management education and key to an effective planned visit. DEs supporting care and self-management education in PC have been shown to improve access and outcomes. For patients to sustain a lifetime of behavior to effectively self-manage, continued support to sustain the ongoing skills, knowledge, and behaviors required to manage their condition is needed. Given the need for enduring support and scarcity of providers, particularly in underserved rural areas, efforts to understand how best to re-design practice to involve DEs in PC and utilize technology to enable and scale engagement in self-management and ongoing support must be considered. The purpose of this application is to evaluate the deployment of Telemedicine for Reach, Education, Access, Treatment and Ongoing Support (TREAT-ON), a DE-driven, PC-based telemedicine model that relies on PC practice redesign to afford access to real-time ongoing support. Investigators hypothesize that the TREAT-ON model will help individuals identified as being high risk in an underserved rural community to achieve and sustain improvements in clinical, psychosocial and behavioral outcomes, and aim to demonstrate the model's viability in terms of feasibility and acceptability to inform future testing of TREAT-ON.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R34DK123370-01 | NIH | None | https://reporter.nih.gov/quic… | View |