Clinical Trials Directory

Trials / Completed

CompletedNCT04263311

Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
195 (actual)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
21 Years – 80 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to work with primary care physicians and their staff, and with community health workers (CHWs) to improve diabetes and hypertension management, health behaviors and improve blood pressure for South Asian patients with uncontrolled diabetes and hypertension in primary care clinics in Atlanta, Georgia. The CHWs are community members who are trained to work with patients to address health needs holistically by providing information on wellness, nutrition, stress relief, and blood pressure management in a culturally-appropriate and language-appropriate manner.

Detailed description

The study will provide research training, technical assistance, and capacity-building to community and clinical sites in Georgia for implementation of culturally tailored, evidenced-based CHW programs to improve HTN and diabetes management for South Asians. In addition, the use a multi-theoretical framework to test the effectiveness of a CHW-led intervention compared to usual care among South Asian individuals with diabetes and uncontrolled HTN in Atlanta. The primary outcome is blood pressure control, defined as 130/80 mmHg. It is hypothesized that, compared to usual care, individuals receiving the CHW intervention will be 20% more likely to achieve blood pressure control at 6 months. And to apply RE-AIM and CFIR frameworks to delineate factors influencing appropriateness, fidelity, adoption, and maintenance of the intervention within clinical and community settings to optimize intervention replication. In addition, this study will serve as a national information and dissemination resource in the adaptation of evidence-based strategies to reduce geographic disparities in HTN and diabetes across Asian American groups.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCHWParticipants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings 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.

Timeline

Start date
2020-07-20
Primary completion
2021-09-30
Completion
2021-09-30
First posted
2020-02-10
Last updated
2024-12-27
Results posted
2024-09-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04263311. Inclusion in this directory is not an endorsement.