Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)
The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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New York
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New York, New York, Estados Unidos, 10016
- NYU Langone Health
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- identified as of South Asian ethnicity
- at least 21 years of age
- a diagnosis of diabetes
- a diagnosis of hypertension
- an uncontrolled BP reading (>130/80mmHg) in the last 6 months
Exclusion Criteria:
- Under the age of 21
- Women who are pregnant at the time of screening
- Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
- Inability to perform unsupervised physical activity
- Malignancy or life-threatening illness with life expectancy of <5 years
- Diagnosed cognitive deficits or limited decision-making capacity
Plan de estudios
¿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 |
|---|---|
|
Experimental: Community Health Workers (CHW) treatment group
There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings. |
Participants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls 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. |
|
Comparador activo: Control group
The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions. |
Participants will attend only the first group-based health education session on hypertension and diabetes management. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent of participants achieving BP control, defined as <130/80 mmHg
Periodo de tiempo: Month 6
|
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months. |
Month 6
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent of participants achieving BP control, defined as <130/80 mmHg
Periodo de tiempo: Month 12
|
The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months. |
Month 12
|
|
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
Periodo de tiempo: Baseline, Month 6
|
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 6
|
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Change from Baseline in HbA1c levels at Month 12
Periodo de tiempo: Baseline, Month 12
|
Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 12
|
|
Change from Baseline in Body mass index (BMI) at Month 6
Periodo de tiempo: Baseline, Month 6
|
Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 6
|
|
Change from Baseline in BMI at Month 12
Periodo de tiempo: Baseline, Month 12
|
Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 12
|
|
Change from Baseline in Systolic blood pressure (SBP) at Month 6
Periodo de tiempo: Baseline, Month 6
|
Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 6
|
|
Change from Baseline in SBP at Month 12
Periodo de tiempo: Baseline, Month 12
|
Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 12
|
|
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
Periodo de tiempo: Baseline, Month 6
|
Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 6
|
|
Change from Baseline in DBP at Month 12
Periodo de tiempo: Baseline, Month 12
|
Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR. |
Baseline, Month 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nadia Islam, PhD, NYU Langone Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19-01192-2
- 5R01MD018528-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: laura.wyatt@nyulangone.org . The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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 will be provided access 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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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