HypertensionNCT04263311
Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
A study testing CHW in people with Hypertension, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 30 Sep 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CHW
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (4)
Change in Haemoglobin A1c (HbA1c)
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: 6 months
Systolic Blood Pressure (SBP)
SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Month 6
Diastolic Blood Pressure (DBP)
DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Month 6
Body Mass Index (BMI)
BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start20 Jul 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263311
- Sponsor's protocol ID
- 19-01192
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2020
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 37845588Shah 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.
PubMed 35940551