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

Not Applicable

• Conditions: Hypertension; Diabetes Mellitus Type II
• Interventions: Behavioral: Integrated CHW Intervention; Behavioral: CHW Session 1 Only

• Registration Number: NCT06542939
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-07
• Study Start: 2024-11-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2028-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Health Workers (CHW) treatment group	Integrated CHW Intervention	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.
Control group	CHW Session 1 Only	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.

Primary Outcome Measures

Name	Time	Method
Percent of participants achieving BP control, defined as <130/80 mmHg	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.

Secondary Outcome Measures

Name	Time	Method
Percent of participants achieving BP control, defined as <130/80 mmHg	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.
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6	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.
Change from Baseline in Systolic blood pressure (SBP) at Month 6	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.
Change from Baseline in Diastolic blood pressure (DBP) at Month 6	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.
Change from Baseline in DBP at Month 12	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.
Change from Baseline in HbA1c levels at Month 12	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.
Change from Baseline in SBP at Month 12	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.
Change from Baseline in Body mass index (BMI) at Month 6	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.
Change from Baseline in BMI at Month 12	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States