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Enrolling by Invitation

NCT Number: NCT06542939

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

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.

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Key information

Conditions

Diabetes Mellitus Type II Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated CHW Intervention

Behavioral

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 and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.

CHW Session 1 Only

Behavioral

Participants will attend only the first group-based health education session on hypertension and diabetes management.

Primary outcomes

  1. Percent of participants achieving BP control, defined as <130/80 mmHg

    Time frame: 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 outcomes

  1. Percent of participants achieving BP control, defined as <130/80 mmHg

    Time frame: 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.

  2. Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6

    Time frame: 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.

  3. Change from Baseline in HbA1c levels at Month 12

    Time frame: 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.

  4. Change from Baseline in Body mass index (BMI) at Month 6

    Time frame: 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.

  5. Change from Baseline in BMI at Month 12

    Time frame: 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.

  6. Change from Baseline in Systolic blood pressure (SBP) at Month 6

    Time frame: 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.

  7. Change from Baseline in SBP at Month 12

    Time frame: 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.

  8. Change from Baseline in Diastolic blood pressure (DBP) at Month 6

    Time frame: 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.

  9. Change from Baseline in DBP at Month 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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