- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04426331
Vouchers to Increase Uptake of Already Free Eye Care
Providing Vouchers Redeemable for Already Free Eye Exams To Increase Uptake Among a Low-Income Minority Population: A Randomized Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital - Wilmer Eye Institute
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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:
- Referred for follow-up at a Screening to Prevent Glaucoma (SToP) study screening event (overarching observational study from which trial sample was drawn). SToP participants were referred for follow-up for any of the following conditions: (1) VA worse than 20/40 in at least 1 eye despite autorefraction; (2) signs of retinal abnormalities on fundus photography; (3) uninterpretable fundus photography; (4) cup-to-disc ratio (CDR) greater than or equal to 0.9, and/or CDR between 0.7 and 0.9 with visual field defects or history of glaucoma; and (5) IOP of 23 mm Hg or greater.
Exclusion Criteria:
- SToP participants who were not referred at the time of screening but later contacted after review of fundus photography
- SToP participants who were referred for follow-up but stated at the time of counseling that they were already under the care of an eye doctor
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: No Voucher
Individuals being referred from screening events randomized to "no intervention" received the standard approach to offering free follow-up examinations (patient education, standard counseling, appointment information packet, reminder phone calls).
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Experimental: Voucher Without Value Information
In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher Without Value Information" received a personal voucher.
|
Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital. The voucher included the patient's name, the screener's name, and an expiration date 90 days from the date of screening. These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. So, with this voucher, both the exam and the glasses will be completely free." |
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Experimental: Voucher With Value Information
In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher With Value Information" received a personal voucher, which differed from the voucher in the second arm since it included a statement of value.
|
Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital, which would normally cost $250. The voucher included the patient's name, the screener's name, an expiration date 90 days from the date of screening, and a statement about the $250 voucher value. These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. These services normally cost about $250, but with this voucher, both the exam and the glasses will be completely free." |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Uptake of follow-up appointment
Periodo de tiempo: Within 90 days of the date of screening
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The primary endpoint was attending a follow-up appointment, either on the initially scheduled or on a rescheduled date within 90 days of the date of screening.
Individuals who did not meet this endpoint either stated that they were not interested in follow-up at the screening event itself, cancelled or did not show for their appointments on 3 occasions, stated that they were not interested in follow-up when study staff attempted to reschedule, or did not show for an appointment and could not be reached for rescheduling after 3 attempts.
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Within 90 days of the date of screening
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Uptake of initial appointment
Periodo de tiempo: Within 90 days of the date of screening
|
Binary indicator for completion of the initially scheduled appointment.
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Within 90 days of the date of screening
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Seema Kacker, PhD, Johns Hopkins School of Medicine
- Investigador principal: David S Friedman, MD PhD, Massachusetts Eye and Ear Hospital
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 (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
- IRB00054137
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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