NCT06542939

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	CHW Session 1 Only	Participants will attend only the first group-based health education session on hypertension and diabetes management.

Timeline

• Start date: 2024-11-11
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2024-08-07
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States