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NCT06542939Enrolling by invitation

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
450 (estimated)
First submitted
5 Aug 2024
Start date
11 Nov 2024
Primary completion date
1 Feb 2028
Lead sponsor
NYU Langone Health
NCT number
NCT06542939

What you commit to

  • Study type: Interventional
  • Planned participants: 450
  • From 11 Nov 2024 to the primary completion date, 1 Feb 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)

Age

  • Under the age of 21
  • Malignancy or life-threatening illness with life expectancy of \<5 years

Other

  • Women who are pregnant at the time of screening
  • Inability to perform unsupervised physical activity
  • Diagnosed cognitive deficits or limited decision-making capacity

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.