Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension in Immigrant Populations (Phase II)
NCT Number: NCT06542939
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus Type II|Hypertension
Interventions: BEHAVIORAL: Integrated CHW Intervention|BEHAVIORAL: CHW Session 1 Only
Sponsor: NYU Langone Health
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31
Locations: NYU Langone Health, New York, New York, 10016, United States

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.

Primary Outcome Measures: 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: 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