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Improving Functional Health Literacy in Older Veterans

20 de enero de 2009 actualizado por: US Department of Veterans Affairs
The objective of this two parallel component study is to develop interventions for the visual and cognitive related health literacy disabilities of older veterans. The first component will test two interventions for improving functional health literacy performance (enhancing the design of health literacy materials and training reading skills) by using a 2 x 2 between subjects factorial design. The second component consists of patient, family, and provider focus groups who will help determine where to apply and disseminate the interventions by identifying problematic sources of text-based health materials. Finally, as a result of both components improved health information design guidelines and training protocols will be developed as rehabilitative interventions for health literacy disability.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Objective of this two parallel component study is to develop interventions for the visual and cognitive related health literacy disabilities of older veterans. The first component will test two interventions for improving functional health literacy performance (enhancing the design of health literacy materials and training reading skills) by using a 2 x 2 between subjects factorial design. The second component consists of patient, family, and provider focus groups who will help determine where to apply and disseminate the interventions by identifying problematic sources of text-based health materials. Finally, as a result of both components, improved health information design guidelines and training protocols will be developed as rehabilitative interventions for health literacy disability.

Specific research questions are:

  1. Can the lower functional health literacy performance of veterans be improved by following text design directives intended to account for age-related visual and cognitive changes (enhanced version)?
  2. Does instruction in skills and strategies for reading yield improvements in functional health literacy performance?
  3. Does instruction in reading skills and enhanced text design improve functional health literacy to a greater extent than either intervention alone?
  4. Are reading gains maintained over time?
  5. What everyday sources of functional health literature are problematic for today's veterans?
  6. How do visual, cognitive, and descriptive factors contribute to change in functional health literacy score?
  7. What is the functional health literacy of older veterans who utilize Atlanta VA health care?

Focus Groups: Three two-hour focus groups will be composed of 15 VA health professionals, 15 outpatient veterans aged 65 and older with low functional health literacy, and 15 family members of veterans with low functional health literacy. These focus groups will identify sources of text-based health information which they find to be problematic from their respective perspectives. These sources, as well as recommendations for the application and dissemination of guidelines and directives for improved health information designs and training protocols, will be compiled using transcription and analysis of focus group sessions.

Interventions: Community dwelling veterans aged 65 and older will be recruited from the Geriatric Primary Care Clinic and the Veteran's Learning Center. Ethnicity, education, health status, general literacy, and other descriptive information will be recorded. Visual baseline measures will include assessments of visual skills for reading and visual function. Cognitive baseline measures will include assessments of word recognition, text comprehension ability, verbal working memory, perceptual speed and vocabulary level. Functional health literacy, measured by the TOFHLA, will be the main outcome measure. This objective and standardized instrument measures the ability of adults to read and understand medical instructional and health care information presented in prose passages and passages containing numerical information. Two hundred and forty participants demonstrating inadequate functional health literacy scores (by the screening instrument STOFHLA) will be randomly assigned to one of four groups: control (N=60), enhanced only (N=60), reading skills and strategies instruction only (N=60), or enhanced with reading skills and strategies instruction (N=60). All participants will receive vision and cognition testing and will then participate in two 2-hour sessions. Depending on group assignment participants will either 1) read standard health-related material (control) 2) read enhanced health-related material (enhanced) 3) receive reading skills training (training) 4) receive reading skills training with enhanced materials (training and enhanced).

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

240

Fase

  • Fase 2

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

    • Georgia
      • Decatur, Georgia, Estados Unidos
        • Va Medical Center

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Older Veterans

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Colaboradores e Investigadores

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

Investigadores

  • David Wolff, Ph.D. Special Assistant to the Director, Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
  • Vicki Mongiardo, Program Analyst, Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service

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

1 de abril de 2001

Finalización del estudio (Actual)

1 de mayo de 2004

Fechas de registro del estudio

Enviado por primera vez

30 de mayo de 2002

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2002

Publicado por primera vez (Estimar)

31 de mayo de 2002

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de enero de 2009

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

20 de enero de 2009

Última verificación

1 de mayo de 2002

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • E2569R

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. .

Ensayos clínicos sobre Health Literacy

3
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