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Integrating Community Health Workers to Improve Diabetes Prevention

Not Applicable
Completed
Conditions
Diabetes Mellitus
Interventions
Behavioral: Data Only
Behavioral: CHW Training
Registration Number
NCT03006666
Lead Sponsor
NYU Langone Health
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
773
Inclusion Criteria
  • Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years prior to the start date of Phase 2.
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Exclusion Criteria
  • A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2 years prior to Phase 2
  • Treatment with DM medication other than metformin (e.g. insulin or oral agents)
  • age greater than 75 years
  • exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW outreach.
  • Does not speak English or Spanish (necessary to communicate with community health worker)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Control Group (Data Only)Data OnlyThe teams randomly allocated to the Control Group will not have access to CHWs.
Intervention Group: (CHW Health Coaching Integrated into Team)CHW TrainingTeams randomly allocated to the Intervention Group will also receive regular panel data on their pre-DM patients and will have a CHW join the team, attend team meetings, and provide an outreach intervention to all prediabetic patients in the panel, as described below. CHWs and the researchers will provide regular updates to the team on these activities.
Primary Outcome Measures
NameTimeMethod
Patient Activation Measure (PAM) scores36 Months

The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.

Incidence rates of type 2 DM36 Months

Cumulative DM incidence rates and time to DM incidence

Weight loss and obesity rates36 Months

Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York University Medical Center

🇺🇸

New York, New York, United States

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