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OpenTrials
Completed

NCT Number: NCT04263311

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Month 6

    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.

Secondary outcomes

  1. Change in Haemoglobin A1c (HbA1c)

    Time frame: 6 months

    Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

  2. Systolic Blood Pressure (SBP)

    Time frame: Month 6

    SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

  3. Diastolic Blood Pressure (DBP)

    Time frame: Month 6

    DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

  4. Body Mass Index (BMI)

    Time frame: Month 6

    BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2020
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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