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Testing the Impact of the MOHR Follow-up Support

15 de junio de 2026 actualizado por: University of Colorado, Denver

Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition

This study will evaluate the impact of 3 different strategies to increase engagement of participants in My Own Health Report (MOHR) and health behavior change activities over time. This study will evaluate the level of engagement, outcomes, cost and cost-effectiveness of these strategies.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

In previous pilot studies was found that patients in clinics randomized to the MOHR intervention vs. control significantly improved physical activity (p < 0.001) and diet risk behaviors (p < 0.001), as well as other risk factors. However, two gaps were identified. First, clinic partners voiced a need for a more flexible menu of delivery options to feasibly adopt and sustain the intervention. Second, to achieve sustained behavior change, particularly for those with unmet social needs, clinics need to provide structured follow-up. Structured follow-up bundles are part of the ERIC strategy of "enhance uptake and adherence (among patients)" and "technical assistance." In other work, additional reminders and resources improved outcomes of goal-setting interventions in general and among those with unmet social needs, so the study team operationalized these to be delivered either electronically (Reminder and Resources (R2) Message) or by a person (R2 Navigation). To fill these two gaps, we engaged with a subset of both UCHealth and rural primary care clinics and patient advisors to co-develop a menu of delivery options for the MOHR intervention and also a menu of options for the R2 Message and R2 Navigation strategy bundles.

In a randomized comparative effectiveness-implementation trial the study team will enroll 1,000 adult patients with two or more cancer risks (including both insufficient physical activity and fruit/vegetable intake). The study team will evaluate the outcomes of R2 Message and R2 Navigation alone or in combination. Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) improvement in practice value outcomes, including patient experience ratings.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1000

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.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Reclutamiento
        • University Of Colorado Hospital
        • Contacto:
        • Investigador principal:
          • Amy Huebschmann
      • Denver, Colorado, Estados Unidos, 80206
        • Reclutamiento
        • UCHealth Cherry Creek Medical Center
        • Contacto:
        • Investigador principal:
          • Amy Huebschmann
      • Denver, Colorado, Estados Unidos, 80045
        • Reclutamiento
        • UCHealth Women's Integrated Services in Health (WISH)
        • Contacto:
      • Denver, Colorado, Estados Unidos, 80230
        • Reclutamiento
        • UCHealth Internal Medical Clinic - Lowry
        • Contacto:
        • Investigador principal:
          • Amy Huebschmann
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Reclutamiento
        • UCHealth Lone Tree Medical Center
        • Contacto:
        • Investigador principal:
          • Amy Huebschmann
      • Westminster, Colorado, Estados Unidos, 80021
        • Reclutamiento
        • UCHealth Family Medicine - Westminster
        • Contacto:
        • Investigador principal:
          • Amy Huebschmann

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Adults, aged 18 years and older.
  • Completion of the MOHR health risk assessment and goal-setting tool
  • Score in the "at-risk" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit/vegetables
  • Patient at one of the participating clinics

Exclusion Criteria:

  • Incomplete or no MOHR assessment
  • Language preference/proficiency other than English or Spanish
  • Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control Arm
Standardized version of usual care
Conductual: Regular care
Regular (standard) care provided by healthcare provider team
Experimental: R2 Message Only
Reminder and Resources Messages sent to patient
Conductual: Regular care
Regular (standard) care provided by healthcare provider team
Conductual: Providing reminder and resources via messages
Patients will be provided reminders and resources using messages sent to patients.
Experimental: R2 Navigation only
Reminder and Resources provided to patient via health navigator
Conductual: Regular care
Regular (standard) care provided by healthcare provider team
Conductual: Reminder and resources sent via navigation
Patients will be provided reminders and resources using health navigators calling the patients.
Experimental: R2 Message + R2 Navigation
Both reminder and resources messages and navigation provided to the patient
Conductual: Regular care
Regular (standard) care provided by healthcare provider team
Conductual: Providing reminder and resources via messages
Patients will be provided reminders and resources using messages sent to patients.
Conductual: Reminder and resources sent via navigation
Patients will be provided reminders and resources using health navigators calling the patients.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of MOHR risk factors
Periodo de tiempo: From enrollment to the follow-up survey timepoint at 2 months.
Primary effectiveness outcome measured on scale from -6 to +6 as change of the number of risk factors improved. MOHR questions are organized into 6 risk areas: 1) intake of fruits and vegetables; 2) high sugar beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep. Each risk factor is evaluated as low risk, medium risk, or high risk. Level of improvement in risk factors outcome will be a count score from -6 to 6 (any improvement or decrement in level of risk in each factor will count as 1 or -1).
From enrollment to the follow-up survey timepoint at 2 months.
REACH - specifically representative engagement
Periodo de tiempo: From enrollment to the follow-up survey timepoint at 6 months.
Primary implementation outcome. Representative engagement: Engagement during the follow-up period involves interactions over time of the participant with either or both a navigator or text messages . Engagement will be assessed percent of navigator calls completed (maximum of 12 over 6 months) and percent of text messages successfully sent (maximum of 60 over 6 months). To assess whether engagement is representative our primary assessments will be if there is differential engagement across conditions (e.g., an interaction effect) based on 1) number of baseline social needs, 2) Latine vs. non Latine ethnicity or 3) digital literacy.
From enrollment to the follow-up survey timepoint at 6 months.
Patient experience
Periodo de tiempo: From enrollment to the follow up survey time point at 6 months.
Primary practice value outcome measured by change in mean score on Patient Assessment of Quality-of-Care subscales of goal setting/tailoring and follow-up/coordination (PACIC). Scale ranges from almost never (indicating the worst patient experience) to almost always (indicating the best patient experience).
From enrollment to the follow up survey time point at 6 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Colorado, Denver

Colaboradores

National Cancer Institute (NCI)

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)

2 de junio de 2026

Finalización primaria (Estimado)

30 de junio de 2029

Finalización del estudio (Estimado)

31 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 25-0224.cc
  • 1R01CA282292-01A1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Due to HIPAA we cannot share IPD from EHR.

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. .

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