- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02903862
Health-eBrain Study (HeB)
Caregivers Virtual Health eBrain Study II
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will track the mental status and cognition of caregivers with and without the Mindoula and DANA intervention and use subject feedback to aid in designing future interventions for caregivers.
This is a remotely administered, virtual study targeting dementia caregivers who are mild to moderately depressed. Screening calls for online administration of four surveys to determine inclusion in the study arms. These surveys will be taken on the Health-eBrain website, both at baseline/screening and throughout participation. All other participation will be completed on the participant's mobile phone, and all psychological and cognitive tests will be self-administered.
This study has a between-group design. Participants will be screened for eligibility and then randomized into each arm. The intervention arm will receive the Mindoula plus DANA intervention. The wait list control arm will take the psychological surveys at regular intervals then, after 12 weeks, be enrolled in the DANA-only observation group. The DANA-only group will take DANA and a usability questionnaire.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Silver Spring, Maryland, Estados Unidos, 20910
- AnthroTronix Inc
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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:
- Females and males who regularly provide care for a person with Alzheimer's Disease
- Between the ages of 45-75
- Self-reported ability to speak and read English
- Providing care for at least a year
Participants in the Intervention and Waitlist Control Arms must meet the following additional inclusion criteria:
- Zarit Burden Inventory (ZBI) Score of 9+
- Overall M3 score of 33+
- M3 Depression score of 7+
- Female Only
- Minimum hours of caregiving a week must be equal to or greater than 20 hours
Exclusion Criteria:
- Anyone with a known cognitive diagnosis
- Anyone with color blindness
- Overall score of high risk on the M3 and/or high risk on the PTSD or Bipolar subsection of the M3
- Failure to meet all inclusion criteria per arm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention Arm
Participants will receive the intervention, Mindoula plus DANA, which involves working with a case manager via an app for 12 weeks.
The case manager will help the participant cope with the stresses of caregiving as well as remind them to use the DANA cognitive assessment app.
This arm will also take the study's psychological surveys.
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The Mindoula intervention is a combination of case management and a messenger application.
Case managers monitor how the participant is doing and any needs and provide 24/7 support & assistance, including care coordination, treatment adherence, and matching the participant with providers and community resources.
Each participant will be given an intake questionnaire to establish goals and behavioral health history.
Participants will use the app and work with the case manager for 12 weeks.
DANA is an FDA-cleared neurocognitive assessment software administered on a smartphone or tablet to measure changes in cognitive efficiency.
DANA also includes Ecological Momentary Assessments to track mood, sleep, stress, and memory.
Intervention participants will take DANA weekly.
The Waitlist Control arm will take DANA weekly 12 weeks after enrollment.
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Otro: Waitlist Control Arm
These participants will take psychological surveys and a usability questionnaire for the first 12 weeks of participation, then, for the 12 weeks following, take the psychological surveys along with DANA and a usability questionnaire.
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DANA is an FDA-cleared neurocognitive assessment software administered on a smartphone or tablet to measure changes in cognitive efficiency.
DANA also includes Ecological Momentary Assessments to track mood, sleep, stress, and memory.
Intervention participants will take DANA weekly.
The Waitlist Control arm will take DANA weekly 12 weeks after enrollment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change from baseline M3 Behavioral Scale score over 12 weeks
Periodo de tiempo: At baseline, and 4, 8, and 12 weeks.
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At baseline, and 4, 8, and 12 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change from baseline Zarit Burden Inventory score over 12 weeks
Periodo de tiempo: At baseline, and 4, 8, and 12 weeks.
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At baseline, and 4, 8, and 12 weeks.
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Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
Periodo de tiempo: At baseline, and 4, 8, and 12 weeks.
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At baseline, and 4, 8, and 12 weeks.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Usability Questionnaire
Periodo de tiempo: At baseline, and 4, 8, and 12 weeks.
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Survey on using DANA that will help the researchers better understand the development of technologies for this population
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At baseline, and 4, 8, and 12 weeks.
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Paired Associates Learning
Periodo de tiempo: At baseline and 12 weeks
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The PAL assesses visual memory and new learning.
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At baseline and 12 weeks
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PERMA Profiler
Periodo de tiempo: At baseline and 12 weeks
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This survey assesses five core element of psychological well-being and happiness - Positive emotions, Engagement, Relationships, Meaning, and Accomplishments - as well as subjective wellbeing and sense of loneliness.
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At baseline and 12 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Corinna E Lathan, Ph.D, AnthroTronix, Inc.
Publicaciones y enlaces útiles
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 (Estimar)
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
- 091614A
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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