Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States
20 de abril de 2022 actualizado por: NYU Langone Health
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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
195
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- NYU Langone
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
CHW intervention:
Inclusion Criteria:
- identified as of South Asian ethnicity
- are at least 21 years of age and younger than age 75
- 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 75
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Community Health Workers (CHW) treatment group
There will be 81 treatment participants who will receive the Community Health Workers (CHW) intervention.
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.
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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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Sin intervención: Control group
There will be 81 control participants who will be offered the health education sessions as a point of service and not for research purposes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in BP control
Periodo de tiempo: Baseline Visit, 6 months visits
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The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) six months following the index office visit.
Individuals receiving care during the implementation of the intervention will be more likely achieve BP control six months following the index office visit than individuals receiving care as usual.
The primary outcome of interest is the proportion of patients who achieve BP control.
this will be measured by the treatment participants and providers surveys.
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Baseline Visit, 6 months visits
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Hemoglobin A1c (HbA1c)
Periodo de tiempo: 6 months
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Change in HbA1c will be measured in participants of CHW intervention versus the control participants.
Clinical data will be retrieved from EHR.
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6 months
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Change in systolic blood pressure (SBP)
Periodo de tiempo: 6 months
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Change in SBP will be measured in participants of CHW intervention versus the control participants.
Clinical data will be retrieved from EHR.
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6 months
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Change in diastolic blood pressure (DBP)
Periodo de tiempo: 6 months
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Change in DBP will be measured in participants of CHW intervention versus the control participants.
Clinical data will be retrieved from EHR.
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6 months
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Change in body mass index (BMI)
Periodo de tiempo: 6 months
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Change in BMI will be measured in participants of CHW intervention versus the control participants.
Clinical data will be retrieved from EHR.
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6 months
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Physicians Attitudes Regarding the Integrated Intervention
Periodo de tiempo: Baseline Visit, 6 months
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Physician attitudes will be primarily assessed with data from brief surveys collected from the participating clinicians.
Survey items with response scales will be designed to capture data on each of the research questions above.
For instance, participants may be asked to respond on a five-point scale (from 1=strongly agree to 5=strongly disagree) to the following statement: "CHWs are helpful tome".
The survey data come from a small sample (n=approximately 10) and are only intended to quantify descriptive information and not for extensive statistical analyses.
The data will be tabulated and summarized descriptively to assess change in attitudes from baseline to 6 months.
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Baseline Visit, 6 months
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Barriers and Facilitators to Implementation Adoption and Implications for Scalability
Periodo de tiempo: Baseline Visit, 6 months visit, 12 month visit
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At baseline, qualitative interviews of key informants will assess current satisfaction and usage of CHWs and organizational workflows.
At follow-up the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated intervention appropriates, fidelity to the interventions and the solicit recommendations for the replication and scalability of the intervention to other sites.
Satisfaction and outcomes from the partnership and capacity building process will also be assessed.
Audio-recordings and interview transcripts will be stripped of all identifying data.
Using a qualitative approach, interview data will be transcribed and analysis will follow "constant comparison" analytic approach.
Using "thematic" coding, initial set of codes will be created which will be reviewed by the CAB to ensure they are relevant and complete.
The coded transcripts will be analyzed with ATLAS.ti, a qualitative data analysis software.
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Baseline Visit, 6 months visit, 12 month visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nadia Islam, NYU Langone
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de julio de 2020
Finalización primaria (Actual)
30 de septiembre de 2021
Finalización del estudio (Actual)
30 de septiembre de 2021
Fechas de registro del estudio
Enviado por primera vez
31 de enero de 2020
Primero enviado que cumplió con los criterios de control de calidad
7 de febrero de 2020
Publicado por primera vez (Actual)
10 de febrero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
20 de abril de 2022
Última verificación
1 de abril de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19-01192
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Marco de tiempo para compartir IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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