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

NYU Langone Health

Status: Invitation-only

Conditions: Hypertension; Diabetes Mellitus Type II

Treatments: Behavioral: CHW Session 1 Only; Behavioral: Integrated CHW Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06542939

19-01192-2

5R01MD018528-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Community Health Workers (CHW) treatment group

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated CHW Intervention

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: CHW Session 1 Only