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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
- ClinicalTrials.gov ID
- NCT04263311
- Acronym / sponsor ID
- 19-01192
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Workers (CHW) treatment group | Experimental | Behavioral: CHWOnce 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. |
| Control group | No intervention | –Control participants will be offered the health education sessions as a point of service and not for research purposes |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHWParticipants 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. | Behavioural | Community Health Workers (CHW) treatment group |
Primary outcome
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.
4 secondary outcomes
Change in Haemoglobin A1c (HbA1c)
Time frame: 6 months
Systolic Blood Pressure (SBP)
Time frame: Month 6
Diastolic Blood Pressure (DBP)
Time frame: Month 6
Body Mass Index (BMI)
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37845588Shah 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.
- Results publication: PubMed 35940551Shah 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Islam principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW in people with Hypertension, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Achieve Blood Pressure (BP) Control. (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263311, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.