CancerNCT00137241
Veterans as Leaders in Understanding and Education (VALUE)
An observational study of Cancer, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse Veterans Affairs Medical Centers (Minneapolis, Portland, Durham, and West Los Angeles), and for specific groups based on age, race, education, and geographic location. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 1,850 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All veterans eligible for care at any of the study facilities (Minneapolis, LA, Durham, and Portland VA Medical Centers) who were scheduled to have at least one primary care visit during the 6-month study recruitment period.
Who cannot join
- Patients were excluded who had: 1) Severe cognitive disorders, 2) Severe visual impairment, 3) Severe hearing impairment, 4) Significant difficulty understanding English
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Official title: Determining the Prevalence of Health Literacy Among Veterans
The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse Veterans Affairs Medical Centers (Minneapolis, Portland, Durham, and West Los Angeles), and for specific groups based on age, race, education, and geographic location. The investigators' secondary objectives are to illustrate the potential significance of poor health literacy by linking estimates for those over 50 years old to colorectal cancer (CRC) screening data and examining variation in screening rates by health literacy levels. The investigators expect that people with lower health literacy skills will be less adherent to CRC screening guidelines.
Read the detailed description
BACKGROUND / RATIONALE:
Studies have shown that people with poor health literacy skills have significantly worse health status, greater risk for hospitalization, less knowledge about their health conditions, and are less likely to use preventative services. Little is known about the prevalence of low health literacy skills among veterans who use the VHA or the effect poor health literacy skills may have on complex preventative behaviors, such as screening for colorectal cancer (CRC). Understanding the distribution of health literacy skills among veterans and their effect on preventive behavior is critical for improving patient education, reducing health disparities, and promoting patient-centered care.
OBJECTIVE(S):
The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse VAMCs (Minneapolis, Portland, Durham, and West LA), and for specific groups based on age, race, education, and geographic location. The secondary objectives are to link health literacy estimates for those 50 to 75 years old to CRC screening data, examine variation in guideline concordant screening rates by health literacy levels, and identify the mechanisms that may mediate or moderate the effect of health literacy on screening.
METHODS:
This observational study uses a time-sequential randomized design of 1440 veterans, stratified by age (<50, 50-75, >75), who have upcoming appointments in primary care clinics at the 4 study sites. Patients who are eligible (i.e., have at least 20/50 vision and are not demented) are asked to participate in a face-to-face structured survey with a study interviewer. The survey includes demographic data, functional status, social support, measures of attitudes and beliefs about health care providers, health insurers, medical care and the Short-Test of Functional Health Literacy in Adults (S-TOFHLA). For those between ages 50-75, knowledge of and attitudes towards CRC screening are also measured. Survey data are then matched to data from the CRC QUERI screening assessment and surveillance data system (CRS 02-162-1) to evaluate screening adherence.
STATUS:
Project work is ongoing.
IMPACT:
Findings from this study are expected to have a number of broad implications for research and practice within the VHA. This project will inform organizational changes aimed to improve the efficacy and efficiency of communication strategies and identify areas where interventions or system-level changes could be most effective; inform improvements in informed consent procedures, patient education, discharge summaries and prescription instructions; inform and improve the effectiveness of interventions and the Quality Enhancement and Research Initiative (QUERI) translation efforts; provide the basis for future longitudinal investigations into how health literacy changes over time; and, contribute to our understanding and amelioration of factors associated with health disparities.
- Conditions
- Cancer
- Keywords
- health literacy, screening, cancer, health disparities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJul 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joan M. Griffin, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137241
- Sponsor's protocol ID
- CRI 03-153
- Status last verified
- Oct 2006
- First submitted
- 25 Aug 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.
PubMed 18335281Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Saha S, Snyder A, Nugent S, Baines Simon A, Gralnek I, Provenzale D, van Ryn M. Variation in estimates of limited health literacy by assessment instruments and non-response bias. J Gen Intern Med. 2010 Jul;25(7):675-81. doi: 10.1007/s11606-010-1304-2. Epub 2010 Mar 12.
PubMed 20224964Griffin JM, Simon AB, Hulbert E, Stevenson J, Grill JP, Noorbaloochi S, Partin MR. A comparison of small monetary incentives to convert survey non-respondents: a randomized control trial. BMC Med Res Methodol. 2011 May 26;11:81. doi: 10.1186/1471-2288-11-81.
PubMed 21615955
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Prevalence of Health Literacy Among Veterans
- ClinicalTrials.gov ID
- NCT00137241
- Acronym / sponsor ID
- CRI 03-153
- Conditions
- Cancer
- Keywords
- health literacy, screening, cancer, health disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse Veterans Affairs Medical Centers (Minneapolis, Portland, Durham, and West Los Angeles), and for specific groups based on age, race, education, and geographic location. The investigators' secondary objectives are to illustrate the potential significance of poor health literacy by linking estimates for those over 50 years old to colorectal cancer (CRC) screening data and examining variation in screening rates by health literacy levels. The investigators expect that people with lower health literacy skills will be less adherent to CRC screening guidelines.
Detailed description
BACKGROUND / RATIONALE:
Studies have shown that people with poor health literacy skills have significantly worse health status, greater risk for hospitalization, less knowledge about their health conditions, and are less likely to use preventative services. Little is known about the prevalence of low health literacy skills among veterans who use the VHA or the effect poor health literacy skills may have on complex preventative behaviors, such as screening for colorectal cancer (CRC). Understanding the distribution of health literacy skills among veterans and their effect on preventive behavior is critical for improving patient education, reducing health disparities, and promoting patient-centered care.
OBJECTIVE(S):
The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse VAMCs (Minneapolis, Portland, Durham, and West LA), and for specific groups based on age, race, education, and geographic location. The secondary objectives are to link health literacy estimates for those 50 to 75 years old to CRC screening data, examine variation in guideline concordant screening rates by health literacy levels, and identify the mechanisms that may mediate or moderate the effect of health literacy on screening.
METHODS:
This observational study uses a time-sequential randomized design of 1440 veterans, stratified by age (<50, 50-75, >75), who have upcoming appointments in primary care clinics at the 4 study sites. Patients who are eligible (i.e., have at least 20/50 vision and are not demented) are asked to participate in a face-to-face structured survey with a study interviewer. The survey includes demographic data, functional status, social support, measures of attitudes and beliefs about health care providers, health insurers, medical care and the Short-Test of Functional Health Literacy in Adults (S-TOFHLA). For those between ages 50-75, knowledge of and attitudes towards CRC screening are also measured. Survey data are then matched to data from the CRC QUERI screening assessment and surveillance data system (CRS 02-162-1) to evaluate screening adherence.
STATUS:
Project work is ongoing.
IMPACT:
Findings from this study are expected to have a number of broad implications for research and practice within the VHA. This project will inform organizational changes aimed to improve the efficacy and efficiency of communication strategies and identify areas where interventions or system-level changes could be most effective; inform improvements in informed consent procedures, patient education, discharge summaries and prescription instructions; inform and improve the effectiveness of interventions and the Quality Enhancement and Research Initiative (QUERI) translation efforts; provide the basis for future longitudinal investigations into how health literacy changes over time; and, contribute to our understanding and amelioration of factors associated with health disparities.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All veterans eligible for care at any of the study facilities (Minneapolis, LA, Durham, and Portland VA Medical Centers) who were scheduled to have at least one primary care visit during the 6-month study recruitment period.
Key exclusion criteria (1 listed)
- Patients were excluded who had: 1) Severe cognitive disorders, 2) Severe visual impairment, 3) Severe hearing impairment, 4) Significant difficulty understanding English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 18335281Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.
- Results publication: PubMed 20224964Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Saha S, Snyder A, Nugent S, Baines Simon A, Gralnek I, Provenzale D, van Ryn M. Variation in estimates of limited health literacy by assessment instruments and non-response bias. J Gen Intern Med. 2010 Jul;25(7):675-81. doi: 10.1007/s11606-010-1304-2. Epub 2010 Mar 12.
- Results publication: PubMed 21615955Griffin JM, Simon AB, Hulbert E, Stevenson J, Grill JP, Noorbaloochi S, Partin MR. A comparison of small monetary incentives to convert survey non-respondents: a randomized control trial. BMC Med Res Methodol. 2011 May 26;11:81. doi: 10.1186/1471-2288-11-81.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan M. Griffin, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137241, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.