- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01380340
Seniors Driving Cessation Early Intervention Group
Study of the Effects of a New Concept of Early Intervention on the Driving Cessation, Mental Health, and Quality of Life of Senior Drivers
This study will investigate the effects of a new form of early intervention for senior drivers who are at risk of changes to their driving status. The early intervention consists of group activities involving planning and professionally facilitated discussion.
There are three main research hypotheses for this study. Firstly, it is hypothesised that early intervention, in the form of the information and planning group, will not be associated with either increases or decreases in driving assessment failure or driving cessation. Secondly, it is hypothesised that early intervention will be associated with patterns of reduced depression and less persistent negative mood states. Thirdly, it is hypothesised that early intervention will be associated with patterns of sustained levels of important quality of life indicators such as community participation and social relationships.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study Protocol Summary:
This Canadian, British Columbian study, in the Fraser Health Authority region will involve seniors who have been referred to two Specialized Seniors Clinics (SSC) and have been flagged by clinicians for report to the Office of the Superintendent of Motor Vehicles (OSMV) for a driving assessment. At the White Rock/South Surrey (WR/SS) SSC,British Columbia (BC),10 subjects will be invited to participate in an information and planning group. Ten additional subjects from New Westminster (NW), BC SSC, will be matched with group participants. Each subject will be interviewed by an occupational therapist during which time the Geriatric Depression Scale (GDS)and an abbreviated version of the World Health Organization Seniors Quality of Life Brief Questionnaire (WHOQOL-BREF) will be administered. Each subject will be contacted by phone bi-monthly for 10 months and the tests will be re-administered. During the phone calls additional information about each senior's driving status and driving patterns will be collected.
Background Information:
This type of early intervention has not previously been researched or made available. Research has shown that seniors who lose their driving license are at increased risk of depression and social isolation. The PI research that preceded this study demonstrated that seniors who had experienced enforced loss of their driving license often showed long-term negative emotions such as anger and bitterness coupled with a sense of injustice.
Purpose of Study The purpose of the study is to explore evidence of possible effects of an early intervention group in the areas of mood, quality of life and community access.
Justification for Study:
An important justification for this study is to examine the effects of a new concept of early intervention. Previous forms of intervention with existing senior drivers prior to assessment have involved activities such as public education and mature driver workshops. These have been evaluated in terms of the growth of knowledge and driving safety. In contrast, the new concept of early intervention involves activities such as group change strategies, positive psychology approaches and topic based discussion designed to mitigate the health and quality of life effects of regulation and cessation. In researching this new concept of early intervention, this project is intended to open up a new field for research. It will provide evidence of what effects can follow from early intervention and will indicate topics to be explored in subsequent research. In addition it will establish a model for the longitudinal research of senior drivers.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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New Westminster, British Columbia, Canadá, V3L 0B2
- New Westminster Specialized Seniors Clinic
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White Rock, British Columbia, Canadá, V4B 2R4
- White Rock Specialized Seniors Clinic
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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:
- Subjects will be invited to participate in the study if they have been referred to the SSC at the start of the study and have a medical condition which is believed to have a potential impact on their driving. They will be living in the community at the time of their referral and they will also be driving their vehicle at that point in time.
Exclusion Criteria:
- Subjects do not qualify to participate in this study if they are not holding a current driving license at the time of recruitment and if they do not have a medical condition that effects their ability to drive.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Seniors early intervention driving group
The seniors early intervention driving group is for seniors who have been identified by professionals as having to face changes to their driving status.
It involves activities such as change strategies, positive psychology approaches and topic based discussion designed to mitigate the health and quality of life effects of driving regulation and cessation.
|
The seniors early intervention driving group is for seniors who have been identified by professionals as having to face changes to their driving status.
It involves activities such as change strategies, positive psychology approaches and topic based discussion designed to mitigate the health and quality of life effects of driving regulation and cessation.
|
|
Sin intervención: Matched comparison group
The subjects will be recruited from a parallel service and will be paired with similar subjects in the experimental group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Geriatric Depression Scale
Periodo de tiempo: 10 months
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The Geriatric Depression Scale (short form)is a well researched, standardized measure of depressive symptoms.It will be administered at the beginning and at the end of the study.
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10 months
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World Health Organization Quality of Life Measure (Brief)
Periodo de tiempo: 10 months
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The WHOQOL-BREF is a short version of the quality of life measure for seniors developed by the World Health Organization.
It will be administered at the start and end of the study.
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10 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jane Rodwell, MA, Fraser Health Authority
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Otros números de identificación del estudio
- FHREB# 2011-051
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. .