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Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease (SCD Mobile Dot)

3 de marzo de 2021 actualizado por: Lakshmanan Krishnamurti, Emory University

Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease

The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects approximately 100,000 individuals in the United States, mostly belonging to minority, under-served populations. SCD is associated with substantial morbidity, premature mortality, individual suffering, health care costs and loss of productivity. Hydroxyurea (HU) the only disease modifying therapy for SCD is efficacious in reducing complications such as pain crisis and acute chest syndrome and improving survival. It is however, vastly underutilized and poorly adhered to because of barriers at the health care system, provider, treatment, socioeconomic, and patient levels. The investigator's overarching hypothesis is that barriers to acceptance and adherence to HU are multi-factorial and that a structured set of interventions can lead to improved adherence to medication and patient centered outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

164

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

  • Estados Unidos
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
        • Children's National Medical Center
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Children's Healthcare of Atlanta
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60607
        • University of Illinois at Chicago
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Children's Hospital of Pittsburgh

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

2 años a 65 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • be >2 years of age up to 65 years of age, inclusive
  • have a diagnosis of SCD, with either βS/βS, βS/βC, βS/βD, βS/β0, βS/βO-Arab, or βS/β+ genotype
  • prescribed Hydroxyurea for at least the 6 months prior to study entry
  • have daily access to a smart phone, tablet, personal computer or other device capable of producing and transmitting videos over the internet
  • be willing and able to record and transmit videos

Exclusion Criteria:

  • patient or caregiver refuses to take Hydroxyurea as treatment for SCD
  • diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study
  • an assessment by the investigator that the subject will not comply with the study procedures outlined in the study protocol
  • patients receiving automatic home delivery of medications since medication possession ratio is reflective of the patient initiation the refill when they have exhausted the home supply of HU

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: Adults - Mobile DOT
Subjects with SCD that are older than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
Conductual: Mobile DOT
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Otros nombres:
  • Comprehensive medication adherence management
Comparador activo: Adults - standard of care then Mobile DOT
Subjects with SCD that are older than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
Conductual: Mobile DOT
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Otros nombres:
  • Comprehensive medication adherence management
Experimental: Children - Mobile DOT
Subjects with SCD that are younger than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
Conductual: Mobile DOT
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Otros nombres:
  • Comprehensive medication adherence management
Comparador activo: Children - standard of care then Mobile DOT
Subjects with SCD that are younger than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
Conductual: Mobile DOT
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Otros nombres:
  • Comprehensive medication adherence management

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medication Possession Ratio (MPR)
Periodo de tiempo: 12 months
Proportion of days the patient is in possession of the medication in the study period
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hemoglobin (Hb) levels
Periodo de tiempo: Baseline, 24 months
Change in hemoglobin levels from baseline to 24 months will be measured using the HemoCue® rapid test.
Baseline, 24 months
Change in mean cell volume (MCV)
Periodo de tiempo: Baseline, 24 months
Change from baseline in MCV will be calculated as the value at 24 months minus the value at baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the red blood cell (RBC) count in millions per microliter of blood, then multiplying by 10.
Baseline, 24 months
Change in fetal hemoglobin (HbF) levels
Periodo de tiempo: Baseline, 24 months
Change from baseline in HbF will be calculated as the value at 24 months minus the value at baseline. HbF is expressed as a percentage.
Baseline, 24 months
Impact of adherence on clinical outcomes and healthcare utilization
Periodo de tiempo: Baseline, 24 months
Health care utilization in the emergency department and hospitalization due to sickle cell related complications such as vaso-occlusive crisis (VOC) or acute chest syndrome (ACS). Retrospective chart review at baseline will be conducted to determine healthcare utilization.
Baseline, 24 months
Impact of adherence on patients' lives
Periodo de tiempo: Baseline, 24 months
Impact of adherence on patients' lives measured using patient reported outcomes (PROMIS), surveys of school attendance, work absenteeism, out-of-pocket costs incurred by patients and their caregivers
Baseline, 24 months
Change in adherence with using Mobile-DOT
Periodo de tiempo: Baseline, 24 months
Retrospective chart review at baseline will be conducted to determine medication possession rate (MPR) and then compared to the MPR at 24 months.
Baseline, 24 months
Acceptability of intervention and of Hydroxyurea
Periodo de tiempo: Baseline, 24 months
Acceptability will be measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness, Side Effects, Convenience, and Global Satisfaction, and it utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Scores range from 0-100, with 0 as extremely dissatisfied and 100 as extremely satisfied.
Baseline, 24 months

Colaboradores e Investigadores

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

Patrocinador

Emory University

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

  • Silla de estudio: Lakshmanan Krishnamurti, MD, Emory University/Children's Healthcare of Atlanta

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)

1 de junio de 2014

Finalización primaria (Actual)

31 de diciembre de 2018

Finalización del estudio (Actual)

31 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

19 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

19 de febrero de 2015

Publicado por primera vez (Estimar)

26 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de marzo de 2021

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

3 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB00074105

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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