Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 5:13 PM
Study NCT ID:
NCT03006666
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2016-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Community Health Workers to Improve Diabetes Prevention
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.
Detailed Description:
This population based trial aims to understand the impact of peer health interventions on panels of patients in a real clinic environment
Investigators will conduct a cluster-randomized trial to test the impact of peer health coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams to:
1. Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
2. Promote weight loss among pre-diabetic patients;
3. Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
1. Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
2. Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
3. Improved health behaviors (e.g. making dietary and exercise changes); and
4. Develop, implement and assess strategies to recruit, train, and integrate peer CHW health coaches within the PCMH model.
This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to promote prevention of DM in PCMH practice.
Investigators will conduct a cluster-randomized trial to test the impact of peer health coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams to:
1. Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
2. Promote weight loss among pre-diabetic patients;
3. Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
1. Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
2. Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
3. Improved health behaviors (e.g. making dietary and exercise changes); and
4. Develop, implement and assess strategies to recruit, train, and integrate peer CHW health coaches within the PCMH model.
This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to promote prevention of DM in PCMH practice.
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?: