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

NYU Langone Health

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: CHW

Study type: Interventional

Funder types: Other

Identifiers

NCT04263311

19-01192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

195 participants in 2 patient groups

Community Health Workers (CHW) treatment group

Experimental group

Description:

Once recruited and consented, surveys will be administered and collected at baseline and 6 months in person or by a study coordinator within two weeks of completion of the CHW coaching component of the intervention. Participants enrolled in the intervention will receive monthly text and phone call reminders. in addition, multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both working individuals and at-home caretakers. Finally, small incentives will be provided at each session to encourage ongoing attendance, and a cash raffle prize will be distributed at program completion for individuals who attend all five sessions.

Treatment:

Behavioral: CHW

Control group

No Intervention group

Description:

Control participants will be offered the health education sessions as a point of service and not for research purposes