Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)

September 28, 2026 updated by: NYU Langone Health

The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • identified as of South Asian ethnicity
  • at least 21 years of age
  • a diagnosis of diabetes
  • a diagnosis of hypertension
  • an uncontrolled BP reading (>130/80mmHg) in the last 6 months

Exclusion Criteria:

  • Under the age of 21
  • Women who are pregnant at the time of screening
  • Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
  • Inability to perform unsupervised physical activity
  • Malignancy or life-threatening illness with life expectancy of <5 years
  • Diagnosed cognitive deficits or limited decision-making capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community Health Workers (CHW) treatment group

There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings.
Behavioral: Integrated CHW Intervention

Participants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
Active Comparator: Control group

The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions.
Behavioral: CHW Session 1 Only

Participants will attend only the first group-based health education session on hypertension and diabetes management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of participants achieving BP control, defined as <130/80 mmHg
Time Frame: Month 6

The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of participants achieving BP control, defined as <130/80 mmHg
Time Frame: Month 12

The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months.
Month 12
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
Time Frame: Baseline, Month 6

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in HbA1c levels at Month 12
Time Frame: Baseline, Month 12

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Body mass index (BMI) at Month 6
Time Frame: Baseline, Month 6

Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in BMI at Month 12
Time Frame: Baseline, Month 12

Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Systolic blood pressure (SBP) at Month 6
Time Frame: Baseline, Month 6

Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in SBP at Month 12
Time Frame: Baseline, Month 12

Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
Time Frame: Baseline, Month 6

Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in DBP at Month 12
Time Frame: Baseline, Month 12

Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Nadia Islam, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2026

Last Update Submitted That Met QC Criteria

September 28, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-01192-2
  • 5R01MD018528-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: laura.wyatt@nyulangone.org . The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to laura.wyatt@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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