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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: CHW

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.

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

CHW intervention:

Inclusion Criteria:

• identified as of South Asian ethnicity
• are at least 21 years of age and younger than age 75
• 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 75
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Health Workers (CHW) treatment group; There will be 81 treatment participants who will receive the Community Health Workers (CHW) intervention. 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.	Behavioral: CHW; Participants 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.
No Intervention: Control group; There will be 81 control participants who will be offered the health education sessions as a point of service and not for research purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BP control	The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) six months following the index office visit. Individuals receiving care during the implementation of the intervention will be more likely achieve BP control six months following the index office visit than individuals receiving care as usual. The primary outcome of interest is the proportion of patients who achieve BP control. this will be measured by the treatment participants and providers surveys.	Baseline Visit, 6 months visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c (HbA1c)	Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.	6 months
Change in systolic blood pressure (SBP)	Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.	6 months
Change in diastolic blood pressure (DBP)	Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.	6 months
Change in body mass index (BMI)	Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.	6 months
Physicians Attitudes Regarding the Integrated Intervention	Physician attitudes will be primarily assessed with data from brief surveys collected from the participating clinicians. Survey items with response scales will be designed to capture data on each of the research questions above. For instance, participants may be asked to respond on a five-point scale (from 1=strongly agree to 5=strongly disagree) to the following statement: "CHWs are helpful tome". The survey data come from a small sample (n=approximately 10) and are only intended to quantify descriptive information and not for extensive statistical analyses. The data will be tabulated and summarized descriptively to assess change in attitudes from baseline to 6 months.	Baseline Visit, 6 months
Barriers and Facilitators to Implementation Adoption and Implications for Scalability	At baseline, qualitative interviews of key informants will assess current satisfaction and usage of CHWs and organizational workflows. At follow-up the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated intervention appropriates, fidelity to the interventions and the solicit recommendations for the replication and scalability of the intervention to other sites. Satisfaction and outcomes from the partnership and capacity building process will also be assessed. Audio-recordings and interview transcripts will be stripped of all identifying data. Using a qualitative approach, interview data will be transcribed and analysis will follow "constant comparison" analytic approach. Using "thematic" coding, initial set of codes will be created which will be reviewed by the CAB to ensure they are relevant and complete. The coded transcripts will be analyzed with ATLAS.ti, a qualitative data analysis software.	Baseline Visit, 6 months visit, 12 month visit

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nadia Islam, NYU Langone

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 19-01192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Researchers who provide a methodologically sound proposal. Upon reasonable request Requests should be directed to laura.wyatt@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No