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Integrating Community Health Workers to Improve Diabetes Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03006666
Recruitment Status : Active, not recruiting
First Posted : December 30, 2016
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: CHW Training Behavioral: Data Only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 773 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Active Comparator: Control Group (Data Only)
The teams randomly allocated to the Control Group will not have access to CHWs.
Behavioral: Data Only
The teams randomly allocated will not have access to Community Health Workers.

Experimental: Intervention Group: (CHW Health Coaching Integrated into Team)
Teams 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.
Behavioral: CHW Training

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.





Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006666


Locations
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United States, New York
New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Mark Schwartz, MD NYU School of Medicine
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03006666    
Other Study ID Numbers: 16-00690
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases