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

NCT06542939 | Enrolling By Invitation

• 2 other identifiers: 19-01192-25R01MD018528-02
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type II; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percent of participants achieving BP control, defined as <130/80 mmHg

  Month 12

• Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6

  Baseline, Month 6

• Change from Baseline in HbA1c levels at Month 12

  Baseline, Month 12

• Change from Baseline in Body mass index (BMI) at Month 6

  Baseline, Month 6

• Change from Baseline in BMI at Month 12

  Baseline, Month 12

Study Arms (2)

Community Health Workers (CHW) treatment group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Integrated CHW Intervention BEHAVIORAL

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.

Community Health Workers (CHW) treatment group

CHW Session 1 Only BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nadia Islam, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)