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Enrolling by invitation NCT06542939

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

No phase Interventional Diabetes Mellitus Type II Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated CHW Intervention, CHW Session 1 Only.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type II, Hypertension. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 an
  • Behavioral CHW Session 1 Only
    Participants will attend only the first group-based health education session on hypertension and diabetes management.

Primary outcome measures

  • Percent of participants achieving BP control, defined as <130/80 mmHg [Time frame: Month 6]
Secondary outcome measures (9)
  • Percent of participants achieving BP control, defined as <130/80 mmHg [Time frame: Month 12]
  • Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6 [Time frame: Baseline, Month 6]
  • Change from Baseline in HbA1c levels at Month 12 [Time frame: Baseline, Month 12]
  • Change from Baseline in Body mass index (BMI) at Month 6 [Time frame: Baseline, Month 6]
  • Change from Baseline in BMI at Month 12 [Time frame: Baseline, Month 12]
  • Change from Baseline in Systolic blood pressure (SBP) at Month 6 [Time frame: Baseline, Month 6]
  • Change from Baseline in SBP at Month 12 [Time frame: Baseline, Month 12]
  • Change from Baseline in Diastolic blood pressure (DBP) at Month 6 [Time frame: Baseline, Month 6]
  • Change from Baseline in DBP at Month 12 [Time frame: Baseline, Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06542939 · 19-01192-2 · 5R01MD018528-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗