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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03324438
Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
Descripción general del estudio
Estado
Condiciones
Descripción detallada
AIM 1: PHASE 1: Use Multiphasic Optimization Strategy (i.e., MOST), a highly efficient experimental strategy, to determine specific components for inclusion in an intervention to 1a) improve primary clinical outcomes of A1C and percentage of time spent in hyperglycemia and 1b) address secondary clinical outcomes by improving adherence and biological markers of complications in high-risk pediatric patients with T1D (A1C=9-12%) as part of 12-month personalized behavioral intervention delivered via in-person T1D clinic visits and home telemedicine.
MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., Randomized Controlled Trials (RCT)) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power.
H1: There will be a main effect of Personalized Adherence Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.
H2: There will be a main effect of Personalized Behavioral Health Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.
AIM 2: PHASE 2: Determine effectiveness of the intervention components on maintenance of A1C, percentage of time spent in hyperglycemia, adherence, and biological markers improvements throughout 6-month follow-up.
H1: Participants who are randomized to T1D medical appointments every 6 weeks will show better improvements in gains in A1C, percentage of time spent in hyperglycemia, adherence, and biological markers compared to those participants who revert to medical appointments occurring every 3 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Barbara Davis Center for Childhood Diabetes
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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:
- youth age 10-17 years
- A1C=9-12%
- parent(s) of child with confirmed diagnosis of T1D
- T1D duration >1 year
- parent and child agree to participate in home telehealth sessions
- ability to use telehealth equipment (i.e., computer, tablet, smartphone with internet connectivity)
Exclusion Criteria:
- developmental disability or reading disorder that prevents understanding of the intervention materials
- non-English speaking adolescents
- those with severe psychological disorders
- prescribed and taking medications that increase blood glucoses
- not seen in T1D clinic within the past year; pregnant if female; situational concerns (e.g., active custody battle)
- type 2 diabetes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Home Telehealth T1D (CoYoT1-HR)
Home Telehealth T1D (C2oYoT1-HR), standard of care delivered via Telehealth for high-risk youth
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1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Otros nombres:
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Experimental: Personalized Adherence Feedback
C2oYoT1-HR+Personalized Adherence Intervention
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1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Otros nombres:
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Experimental: Personalized Behavioral Health
C2oYoT1-HR+Personalized Behavioral Health
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1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Otros nombres:
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Experimental: C2oYoT1-HR + Adherence + Behavioral
C2oYoT1-HR + both Personalized Adherence Feedback + Personalized Behavioral Health (C2oYoT1-HR + Adherence + Behavioral)
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1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Otros nombres:
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Otros nombres:
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Periodo de tiempo: weeks 1, 12, 24, 36, 48, 72
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A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits.
In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36).
The rationale for measurement at these study visits is that they occur every 3 months, which is the interval in which A1C is measured as standard of care.
Change in A1c will be looked at from baseline every 3 months throughout the study.
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weeks 1, 12, 24, 36, 48, 72
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Hyperglycemia - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Periodo de tiempo: weeks 1, 12, 24, 36, 48, 72
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Time spent in hyperglycemia - change will be looked at from baseline every 12 weeks throughout the study.
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weeks 1, 12, 24, 36, 48, 72
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Pediatric Diabetes Quality of Life Scale - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Periodo de tiempo: weeks 1, 12, 24, 36, 48, 72
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The PDQ is a 20-question self-administered scale that evaluates and quantifies the quality of life as related to diabetes - change will be looked at from baseline every 3 months throughout the study.
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weeks 1, 12, 24, 36, 48, 72
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adherence - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Periodo de tiempo: weeks 1, 12, 24, 36, 48, 72
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Objectively Measured Adherence, Self-Reported Adherence, Number of T1D Appointments Attended.
- change will be looked at from baseline every 3 months throughout the study.
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weeks 1, 12, 24, 36, 48, 72
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Psychosocial Measures - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Periodo de tiempo: weeks 1, 24, 48, 72
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Diabetes Family Conflict Scale (DFCS), Diabetes Family Responsibility Questionnaire (DFRQ), Hypoglycemia Fear Scale (HFS), Patient Health Questionnaire - 9 (PHQ-9), Problem Area in Diabetes Version (PAID), Puberty - change will be looked at from baseline every 3 months throughout the study.
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weeks 1, 24, 48, 72
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Biological Markers of T1D Complications - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Periodo de tiempo: weeks 1, 24, 48, 72
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Urinary microalbumin, endothelial function - change will be looked at from baseline every 3 months throughout the study.
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weeks 1, 24, 48, 72
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kimberly A Driscoll, PhD, University of Colorado, Denver
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17-0004 (DMID)
- DP3DK113363 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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