Clinical trial NCT04263311: Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
Official title: Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 195
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: CHW intervention:

Inclusion Criteria:

* identified as of South Asian ethnicity
* are at least 21 years of age and younger than age 80
* had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months
* a diagnosis of diabetes
* a diagnosis of hypertension
* an uncontrolled BP reading (\>130/80mmHg) in the last 6 months

Provider Surveys Inclusion criteria

* clinicians employed by the clinic
* have enrolled into the study.

Key Informant Interviews Inclusion criteria

* must be a provider, clinic manager, or community health worker.

CHW intervention

Exclusion Criteria:

* under the age of 21 and older than 80
* pregnant
* Type 1 diabetes or diabetes secondary to other conditions
* malignancy or life threatening illness with life expectancy of \<5 years
* inability to perform unsupervised physical activity
* diagnosed cognitive deficits or limited decision-making capacity

Provider Surveys Inclusion criteria

* clinicians who are unable to complete the survey in the English language.

Key Informant Interviews Inclusion criteria

* who are unable to participate in the interview conducted in the English language.

Primary outcomes:
measure: Percentage of Patients Who Achieve Blood Pressure (BP) Control.
timeFrame: Month 6
Secondary outcomes:
measure: Change in Haemoglobin A1c (HbA1c)
timeFrame: 6 months
measure: Systolic Blood Pressure (SBP)
timeFrame: Month 6
measure: Diastolic Blood Pressure (DBP)
timeFrame: Month 6
measure: Body Mass Index (BMI)
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone
name: Nadia Islam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah MK, Wyatt LC, Gibbs-Tewary C, Zanowiak JM, Mammen S, Islam N. A Culturally Adapted, Telehealth, Community Health Worker Intervention on Blood Pressure Control among South Asian Immigrants with Type II Diabetes: Results from the DREAM Atlanta Intervention. J Gen Intern Med. 2024 Mar;39(4):529-539. doi: 10.1007/s11606-023-08443-6. Epub 2023 Oct 16.
citation: Shah MK, Wyatt LC, Gibbs-Tewary C, Zanowiak J, Mammen S, Mohsin FM, Islam N. Protocol and baseline characteristics for a community health worker-led hypertension and diabetes management program for South Asians in Atlanta: The DREAM Atlanta study. Contemp Clin Trials. 2022 Sep;120:106864. doi: 10.1016/j.cct.2022.106864. Epub 2022 Aug 5.