Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038337
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-05-30
Brief Title:
Improving Functional Health Literacy in Older Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Functional Health Literacy in Older Veterans
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 todays 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 Veterans 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 N60 enhanced only N60 reading skills and strategies instruction only N60 or enhanced with reading skills and strategies instruction N60 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
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 todays 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 Veterans 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 N60 enhanced only N60 reading skills and strategies instruction only N60 or enhanced with reading skills and strategies instruction N60 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None