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

NCT04263311 | Completed Results

• 1 other identifier: 19-01192
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Achieve Blood Pressure (BP) Control.

  The primary outcome will be the percentage of eligible patients at a practice site to achieve BP control (130/80 mmHg) six months following the index office visit. The primary outcome will be measured by the treatment participants and providers surveys.

  Month 6

Secondary Outcomes (4)

• Change in Haemoglobin A1c (HbA1c)

  6 months

• Systolic Blood Pressure (SBP)

  Month 6

• Diastolic Blood Pressure (DBP)

  Month 6

• Body Mass Index (BMI)

  Month 6

Study Arms (2)

Community Health Workers (CHW) treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

CHW BEHAVIORAL

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.

Community Health Workers (CHW) treatment group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• clinicians employed by the clinic
• have enrolled into the study.
• must be a provider, clinic manager, or community health worker.
• CHW intervention

You may not qualify if:

• 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
• clinicians who are unable to complete the survey in the English language.
• who are unable to participate in the interview conducted in the English language.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 37845588 RESULT

• 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.

  PMID: 35940551 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jennifer Zanowiak
• Organization: NYU Langone Health

Jennifer.Zanowiak@nyulangone.org

(646) 501-3502

Study Officials

• Nadia Islam

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 10, 2020
• Study Start: July 20, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 27, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)