ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Improving Functional Health Literacy in Older Veterans

This study has been completed.
Study NCT00038337.   Last updated on December 13, 2007.   Information provided by Department of Veterans Affairs

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Improving Functional Health Literacy in Older Veterans
Official Title  Improving Functional Health Literacy in Older Veterans
Brief Summary

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.

Detailed Description

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).

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Visual And Cognitive Disability
Intervention  Procedure: Health Literacy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  240
Start Date  April 2001
Completion Date May 2004
Eligibility Criteria 

Older Veterans

Gender Both
Ages 65 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00038337
Organization ID E2569R
Secondary IDs ††
Study Sponsor  Department of Veterans Affairs
Collaborators ††
Investigators 
Investigator:     David Wolff, Ph.D. Special Assistant to the Director     Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service    
Investigator:     Vicki Mongiardo, Program Analyst     Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service    
Information Provided By Department of Veterans Affairs
Verification Date May 2002
First Received Date  May 30, 2002
Last Updated Date December 13, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers