Improving Functional Health Literacy in Older Veterans

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00038337
First received: May 30, 2002
Last updated: January 20, 2009
Last verified: May 2002
  Purpose

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.


Condition Intervention Phase
Visual And Cognitive Disability
Procedure: Health Literacy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Functional Health Literacy in Older Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 240
Study Start Date: April 2001
Study Completion Date: May 2004
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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Older Veterans

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038337

Locations
United States, Georgia
VA Medical Center
Decatur, Georgia, United States
Sponsors and 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00038337     History of Changes
Other Study ID Numbers: E2569R
Study First Received: May 30, 2002
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Health Literacy
Visual
Cognitive

ClinicalTrials.gov processed this record on September 18, 2014