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

The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health workers (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: Hypertension; Diabetes Mellitus Type II
• Intervention / Treatment: Behavioral: Integrated CHW Intervention; Behavioral: CHW Session 1 Only

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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
• Type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
• inability to perform unsupervised physical activity

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	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	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	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	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	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

• 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

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): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2
• 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