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OpenTrials
Completed

NCT Number: NCT03006666

Integrating Community Health Workers to Improve Diabetes Prevention

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Medical Center

New York, 10016, United States

About this study

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:

  • Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
  • Promote weight loss among pre-diabetic patients;
  • Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
  • Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
  • Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
  • Improved health behaviors (e.g. making dietary and exercise changes); and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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)

Treatment and study plan

CHW Training

Behavioral

CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.

In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .

The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with "mock" participants (consisting of research staff and advisory board members).

Individuals who do not pass will receive intensive remediation and be required to repeat the examination.

Community Health Worker Coaching Intervention.

Data Only

Behavioral

The teams randomly allocated will not have access to Community Health Workers.

Primary outcomes

  1. Incidence rates of type 2 DM

    Time frame: 36 Months

    Cumulative DM incidence rates and time to DM incidence

  2. Weight loss and obesity rates

    Time frame: 36 Months

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

  3. Patient Activation Measure (PAM) scores

    Time frame: 36 Months

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2016
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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