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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06542939
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Nov 2025
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Community Health Workers (CHW) treatment group
    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.
  • Active Comparator: Control group
    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 Measure

Percent of participants achieving BP control, defined as <130/80 mmHg [ Time Frame: Month 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
NYU Langone Health· New York, NY

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