- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01235429
Partners in Care Diabetes Self-management Intervention
Specific Aim 3: Partners in Care Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a feasibility study using a randomized controlled trial (RCT) design in which 100 Native Hawaiians (NHs) and other Pacific Islanders (PPs) will be randomized to either a 3-month diabetes self-management group (DSMG; N=50) or a delayed intervention control group (CG; N=50). Participants in the DSMG will receive culturally-tailored, group diabetes self-management education delivered in a community setting by trained community peer educators. To meet this objective, we have partnered with four community-based organizations: 1) Hawai'i Maoli Association of Hawaiian Civic Clubs, 2) Ke Ola Mamo Native Hawaiian Health Care System, 3) Kokua Kalihi Valley Comprehensive Family Services, and 4) Kula No Nā Po'e Hawai'i. These four organizations provide services to a large number of Pacific People to include, but not limited to, Native Hawaiians, Samoans, Filipinos, and Chuukese. They already have intervention research experience as members of the PILI 'Ohana CBPR Project. The 3-month face-to-face intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) >=8% will be recruited for the study because they represent the most at-risk for diabetes-related complications.
Over a 1-year accrual period, the community partners will recruit and enroll 100 eligible NHs and PPs (25 participants per a participating community), as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- University of Hawaii
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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:
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background,
- Adults age >=18 years,
- English-speaking,
- Physician-diagnosed type 2 diabetes, and
- Baseline hemoglobin A1c >=8%
Exclusion Criteria:
- Survival less than 6 months,
- Planning to move off island or out of state during the study period,
- Pregnancy,
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Educational
Participants will receive 12 diabetes self-management educational lessons in a small group setting located within the participating communities and delivered by trained community health workers.
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Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.
Diabetes self-management education
|
|
Comparador activo: Delayed education
The delayed education group will receive the same intervention after the intervention group has completed the educational lessons and all participants have completed the follow-up assessments.
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Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.
Diabetes self-management education
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
hemoglobin A1c
Periodo de tiempo: 3 months
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Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.
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3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life
Periodo de tiempo: 3 months
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Quality of life using the Problem Areas in Diabetes survey will be assessed at baseline and post intervention in the intervention and delayed intervention participants.
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph K Kaholokula, PhD, University of Hawaii
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PILI ARRA Supplement
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