diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED) (ENHANCED)
This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED randomized control trial. The study is being conducted by the Minneapolis Heart Institute Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).
The study will examine the impact of a registered dietitian-led, primary care integrated, telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c <8%, not using tobacco and taking an aspirin as appropriate.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Individuals will be invited to attend a baseline visit where they will have lab work done, anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment. They will formally consent to participation by signing a study consent form. The same measures will be collected after completion of the one year study.
Study participants will receive two sessions of free lab work, a diabetes education book, and brief coaching with a registered dietitian/certified diabetes educator. In addition, those randomized to the phone coaching will have access to a registered dietitian/certified diabetes educator on a monthly basis for one year of personalized health coaching for free. The intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin use).
This program is designed to complement usual clinic-based primary care, with coaches documenting lab, biometrics and medication adjustments in the EHR, along with documenting phone encounters and communicating directly with patients' PCPs as needed. Documentation in the EHR uses an order created specifically for the study indicating the patient's research status.
Lab work required as part of this research study at baseline and 12 months is covered by the study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month study visits are the responsibility of the patient and/or their insurance
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of Type 2 Diabetes
- Individuals who are not meeting 3 or more D5 goals,
- Have had a visit with a provider within the last 2 years
Exclusion Criteria:
- Type 1 Diabetes
- Chronic kidney disease (GFR <30)
- HIV
- Institutional residence
- Major cognitive or language barrier (as determined by program enrollment staff)
- Other active end-stage disease (e.g., late stage cancer or pulmonary disease)
- Actively receiving cancer treatment
- Pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health.
Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
|
Focus on nutrition, activity and appropriate medication use and adherence
|
|
Sin intervención: Standard of Care
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
A1c (Laboratory Assessment)
Periodo de tiempo: 1 year
|
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
|
1 year
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
Periodo de tiempo: 1 year
|
The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
|
1 year
|
|
Tobacco Use (Self-reported Questionnaire)
Periodo de tiempo: 1 year
|
The count of participants represents those not using tobacco at follow up
|
1 year
|
|
Statin Use (as Noted in EMR)
Periodo de tiempo: 1 year
|
The count of participants represents those taking a statin as indicated at follow up
|
1 year
|
|
Aspirin Use (as Noted in EMR)
Periodo de tiempo: 1 year
|
The count of participants represents taking aspirin as indicated at follow up
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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 (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
- ENHANCED
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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