Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Medicine
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- BMI ≥ 27 kg/m2
- ≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
- Registered in Northwestern Medical Group's EpicCare MyChart patient portal
- Received and completed MyChart survey of weight loss interest
- Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.
Exclusion Criteria:
- Evidence of hospitalization in past 30 days
- Most recent blood pressure >180/105
- Cancer (non-skin) treatment within the past 2 years
- Encounter diagnosis for hypoglycemia in past 30 days
- Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: Basic Resources and Services
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
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Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
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Experimental: Coordinated Primary Care Population Management (C3PO)
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal.
Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team.
Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
Periodo de tiempo: Baseline - 6 Months
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Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
|
Baseline - 6 Months
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Costs to Implement the Intervention
Periodo de tiempo: Baseline - 12 Months
|
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
|
Baseline - 12 Months
|
|
Change in Hemoglobin A1C
Periodo de tiempo: Baseline - 12 Months
|
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Systolic Blood Pressure
Periodo de tiempo: Baseline - 12 Months
|
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Total Cholesterol
Periodo de tiempo: Baseline - 12 Months
|
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Non-HDL Cholesterol
Periodo de tiempo: Baseline - 12 Months
|
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
|
Baseline - 12 Months
|
|
Body Mass Change at 6 Months
Periodo de tiempo: Baseline - 6 Months
|
Mean Change in Body Mass (kg) from Baseline to 6 Months
|
Baseline - 6 Months
|
|
Body Mass Change at 12 Months
Periodo de tiempo: Baseline - 12 Months
|
Mean Change in Body Mass (kg) from Baseline to 12 Months
|
Baseline - 12 Months
|
|
Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
Periodo de tiempo: Baseline - 12 Months
|
Proportion of Participants who Reach a 5% Weight Loss Goal at 12 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 12 months (kg))/(Baseline body mass (kg))
|
Baseline - 12 Months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- STU00207153
- R34DK114773 (Subvención/contrato del NIH de EE. UU.)
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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