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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | Control participants will be offered the health education sessions as a point of service and not for research purposes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Systolic Blood Pressure (SBP) |
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CHW intervention:
Inclusion Criteria:
Provider Surveys Inclusion criteria
Key Informant Interviews Inclusion criteria
CHW intervention
Exclusion Criteria:
Provider Surveys Inclusion criteria
Key Informant Interviews Inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nadia Islam | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37845588 | Result | 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. | |
| 35940551 |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Community Health Workers (CHW) Treatment Group | 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. 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. |
| FG001 | Control Group | Control participants will be offered the health education sessions as a point of service and not for research purposes |
| FG002 | Non Randomized | Participants who were consented but were not randomized to either group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data was not collected for the "Non Randomized" Arm/Group as these patients became ineligible post consent, and were removed from the study prior to being randomized to an arm. Only baseline data was reported for the participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Community Health Workers (CHW) Treatment Group | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | Month 6 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Community Health Workers (CHW) Treatment Group | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Zanowiak | NYU Langone Health | (646) 501-3502 | Jennifer.Zanowiak@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2023 | Apr 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
| 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. | 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. | Month 6 |
| 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. |
| Left the country |
|
| Unable to maintain time commitment |
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| No longer interested |
|
| Ineligible post consent |
|
| BG001 | Control Group | Control participants will be offered the health education sessions as a point of service and not for research purposes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | Control participants will be offered the health education sessions as a point of service and not for research purposes |
|
|
| Secondary | 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. | This study was launched during COVID and the study team had difficulty collecting the data from all participants due to the pandemic. Data collection from all participants was not an option due to the preference for telemedicine appointments vs in-person appointments. A1c data was collected through the electronic medical record and reported on data that was available, the remaining data is missing. | Posted | Mean | Standard Deviation | Percentage change in HbA1c | 6 months |
|
|
|
| Secondary | Systolic Blood Pressure (SBP) | SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. | Posted | Mean | Standard Deviation | mmHg | Month 6 |
|
|
|
| Secondary | Diastolic Blood Pressure (DBP) | DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. | Posted | Mean | Standard Deviation | mmHg | Month 6 |
|
|
|
| Secondary | Body Mass Index (BMI) | BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. | Posted | Mean | Standard Deviation | kg/m2 | Month 6 |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Control Group | Control participants will be offered the health education sessions as a point of service and not for research purposes | 0 | 91 | 0 | 91 | 0 | 91 |
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