Reducing Assessment Barriers for Patients With Low Literacy
NCT ID: NCT03584490
Last Updated: 2024-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
729 participants
INTERVENTIONAL
2018-09-14
2023-07-31
Brief Summary
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Detailed Description
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Improving self-report assessment. Health surveys are ubiquitous, but almost no questionnaires used across the country have been validated for use with people who have low health literacy. This is a glaring shortcoming in current survey validation methodology; inaccurate surveys lead to false conclusions and threaten the empirical foundation of everyone's efforts to understand and improve public health, healthcare, and health outcomes. Our goal is to rectify this shortcoming. This study will 1) determine the effect of health literacy on widely-used questionnaires, 2) determine the stability of psychometric properties of questionnaires over time, and 3) test various testing formats to determine which ones work best for people with low health literacy.
Due to the COVID-19 pandemic, the study will implement phone-based assessments in addition to the original in-person protocol described above. The phone-based assessments will only be available to enrolled or previously enrolled participants. Participants will be asked questionnaires over the phone by a research coordinator at 3 time-points over 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Additionally, due to the COVID-19 pandemic, participants can optionally enroll in a phone-based assessment that includes 3 time-points over 6 months.
BASIC_SCIENCE
NONE
Study Groups
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Pen-and-paper format
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Phone Administration of Questionnaires
This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
Computerized Talking Touchscreen
This group will receive the Computerized Talking Touchscreen intervention.
Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.
Computerized Talking Touchscreen
The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires
This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
Interventions
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Computerized Talking Touchscreen
The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.
Phone Administration of Questionnaires
This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.
Eligibility Criteria
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Inclusion Criteria
* Be willing to provide informed consent, including signing the consent form
* Be willing to be randomized to administration method
* Be willing to complete questionnaires and interviews
* Be fluent in English and/or Spanish
* Be willing to attend three face-to-face sessions
* Have no plans to move out of the study area in the next six months
Exclusion Criteria
* Being a prisoner, detainee, or in police custody
* Unable to complete the consent process
* Inadequate vision to see study materials (worse than 20/80 corrected)
* Inadequate hearing or manual dexterity to use the computer system
Phone-based protocol:
2. Access to reliable phone connection
3. Be willing to participant in three phone-based sessions
1. Unable to complete the consent process
2. Inadequate hearing for phone-based assessments
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Northwestern University
OTHER
Responsible Party
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James W Griffith
Research Assistant Professor of Medical Social Sciences
Principal Investigators
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James Griffith, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/
Wolf MS, Gazmararian JA, Baker DW. Health literacy and functional health status among older adults. Arch Intern Med. 2005 Sep 26;165(17):1946-52. doi: 10.1001/archinte.165.17.1946.
Sudore RL, Yaffe K, Satterfield S, Harris TB, Mehta KM, Simonsick EM, Newman AB, Rosano C, Rooks R, Rubin SM, Ayonayon HN, Schillinger D. Limited literacy and mortality in the elderly: the health, aging, and body composition study. J Gen Intern Med. 2006 Aug;21(8):806-12. doi: 10.1111/j.1525-1497.2006.00539.x.
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Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22. doi: 10.1200/JCO.2004.10.149.
Hurstak EE, Paasche-Orlow MK, Hahn EA, Henault LE, Taddeo MA, Moreno PI, Weaver C, Marquez M, Serrano E, Thomas J, Griffith JW. The mediating effect of health literacy on COVID-19 vaccine confidence among a diverse sample of urban adults in Boston and Chicago. Vaccine. 2023 Apr 6;41(15):2562-2571. doi: 10.1016/j.vaccine.2023.02.059. Epub 2023 Mar 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form: Original Protocol
Document Type: Informed Consent Form: Verbal Consent - Phone Protocol
Other Identifiers
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STU00202907
Identifier Type: -
Identifier Source: org_study_id
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