- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03487692
Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes (MESSAGES)
1 de noviembre de 2022 actualizado por: University of Chicago
Diabetes MESSAGES (Medical Care, Education, Social Support, And Goal-setting to Empower Self-management): Implementing Diabetes Group Visits and Text Messaging in Community Health Centers
Diabetes group visits, shared appointments where patients receive self-management education in a group setting and have a medical visit, are a promising way to deliver high quality diabetes care.
Group visits can improve glycemic control and decrease healthcare utilization.
To date, no studies have systematically implemented a diabetes group visit intervention in a network of U.S. community health centers.
The University of Chicago is partnering with Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten Midwestern states.
Approximately half of all Federally Qualified Health Centers in this region are affiliated with MWCN.
The objectives of the study are [1] providers and staff at 20 health centers will have the requisite knowledge, skills, and motivation to implement a diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical outcomes; and health care utilization for patients participating in the diabetes group visit program will be evaluated; and [3] the diabetes group visit program will be available for dissemination among and use by health centers and healthcare providers at the local, state, regional, and national levels.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
UChicago and MWCN will recruit and enroll 20 health centers (HCs) to participate in a training intervention and to implement diabetes group visit and text messaging programs at their clinic sites.
Each HC will assemble a team of 3-4 providers and staff to participate in the training.
HCs will be randomized to one of two training cohorts.
HC providers and staff will attend two in-person Learning Sessions in Chicago and a series of monthly webinars, recruit and enroll patients, implement a 6-month diabetes group visit and text messaging program plus subsequent booster sessions, complete periodic surveys and interviews, assist with data collection through patient surveys and chart abstraction, and present their program to peer HCs during Learning Sessions and to local stakeholders, state primary care organizations, or other professional groups.
Each HC will enroll 15 patients in the group visit and text messaging program; the 2018 Training Cohort will do so immediately following their enrollment in the study and the 2020 Training Cohort will do so after 18 months.
During the first 18 months, the 2020 Training Cohort will collect data from electronic health records (EHR) of randomly selected patients to serve as a control group.
Changes in self-reported outcomes, diabetes processes of care, and clinical outcomes will be assessed for intervention patients from baseline through 2 year follow up, and processes of care and clinical outcomes will be compared for intervention vs. control participants.
Capacity of HC providers and staff to conduct a group visit and text messaging intervention for patients with diabetes, as well as their confidence in identifying and addressing health disparities, will be evaluated through surveys and in-depth interviews.
This study will expand knowledge of the barriers, facilitators, and perceived benefits and drawbacks of group visit and text messaging interventions and inform the development of a toolkit that will be disseminated to other HCs.
Tipo de estudio
Intervencionista
Inscripción (Actual)
265
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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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 18 years or older
- diagnosis of type 2 diabetes
- attended at least two appointments at the HC within the past year, with at least one of them being during the past six months
- last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months)
- own a cellular phone with text messaging capabilities
- have the ability to read and send text messages
- English or Spanish speaking
Exclusion Criteria:
- pregnant or planning to become pregnant
- uncontrolled psychiatric problem
- dementia or other cognitive impairment
- hearing difficulties or severe physical disability that would prevent them from participation in group visit
- planning to relocate in the next year or leave the area during the group visit period
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 2018 Training Cohort
10 health centers will be randomized to the 2018 Training Cohort.
Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).
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Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient.
At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program.
Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
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Otro: 2020 Training Cohort
10 health centers will be randomized to the 2020 Training Cohort.
Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group.
After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).
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During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care.
After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient.
At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program.
Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Hemoglobin A1C
Periodo de tiempo: change from baseline to 12 months
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change from baseline to 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hemoglobin A1C
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
|
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Blood pressure
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
|
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Weight
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Cholesterol
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Diabetes processes of care
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Receipt of recommended screenings, exams, referrals, and vaccinations
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Medication management of diabetes
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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changes in prescribed diabetes medications for patients with inadequate diabetes control
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of hypoglycemic events
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Number of hospital admissions
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of primary care, specialist, and ER visits
Periodo de tiempo: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
|
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Smoking status
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Health related quality of life (SF-12)
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Depression (PHQ-2)
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Summary of Diabetes Self-Care Activities Measure
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Understanding of Diabetes Self-Management (Diabetes Care Profile)
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Attitudes Towards Diabetes (Diabetes Care Profile)
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Distress Scale (DDS-2)
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Quality of Life Scale
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Self-Empowerment Scale
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Social Support Scale
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with intervention
Periodo de tiempo: 6 month and 12 month for intervention patients only
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6 month and 12 month for intervention patients only
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CAHPS Overall Rating
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with overall care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Cultural Competency
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with cultural competency of care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Provider Communication
Periodo de tiempo: baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with provider communication at health center
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baseline, 6 month, and 12 month for intervention patients only
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient engagement
Periodo de tiempo: through study completion, an average of 2 years
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Attendance/participation in group visits, text messaging, and booster sessions
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through study completion, an average of 2 years
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Health center provider/staff preparedness
Periodo de tiempo: change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Capacity, confidence, motivation, perceived benefits and barriers
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change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Health center provider/staff satisfaction
Periodo de tiempo: post-training (16 month)
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Satisfaction with training, group visits, and text messaging
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post-training (16 month)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Arshiya Baig, MD, MPH, University of Chicago
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)
18 de octubre de 2018
Finalización primaria (Actual)
15 de mayo de 2022
Finalización del estudio (Actual)
30 de junio de 2022
Fechas de registro del estudio
Enviado por primera vez
21 de marzo de 2018
Primero enviado que cumplió con los criterios de control de calidad
27 de marzo de 2018
Publicado por primera vez (Actual)
4 de abril de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de noviembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
1 de noviembre de 2022
Última verificación
1 de noviembre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB17-1385
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .
Ensayos clínicos sobre Diabetes mellitus tipo 2
-
AstraZenecaReclutamiento
-
Daewoong Pharmaceutical Co. LTD.Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)
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University of ZambiaUniversity Teaching Hospital, Lusaka, ZambiaAún no reclutandoDiabetes Mellitus Tipo 2 Sin Complicaciones
-
Zhongda HospitalReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Newsoara Biopharma Co., Ltd.ReclutamientoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
Shanghai Golden Leaf MedTec Co. LtdActivo, no reclutandoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Haisco Pharmaceutical Group Co., Ltd.TerminadoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
PegBio Co., Ltd.TerminadoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Oramed, Ltd.IntegriumTerminadoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
Ensayos clínicos sobre Diabetes MESSAGES Program
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IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de ansiedadCanadá
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The University of Hong KongSydney Children's Hospitals Network; SAHKReclutamientoDesorden del espectro autistaHong Kong
-
Akdeniz UniversityAún no reclutandoAccidente cerebrovascular isquémico | EntrenamientoPavo
-
Children's HealthActivo, no reclutandoDesorden del espectro autistaEstados Unidos
-
Massachusetts General HospitalActivo, no reclutandoCáncer de pulmón de células no pequeñas | Mesotelioma | Cáncer de pulmón de células pequeñas | Terapia de conducta cognitivaEstados Unidos
-
Chinese University of Hong KongReclutamiento
-
Children's Hospital Los AngelesNational Center for Advancing Translational Sciences (NCATS); AltaMed Health...SuspendidoCrianza de los hijos | Problema de comportamiento infantil | Crianza de los hijosEstados Unidos