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Reducing Assessment Barriers for Patients With Low Literacy

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ClinicalTrials.gov Identifier: NCT03584490
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : March 29, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
James W Griffith, Northwestern University

Brief Summary:
The purpose of this study is to determine the effects of health literacy on questionnaire-based measurement.

Condition or disease Intervention/treatment Phase
Health Literacy Other: Computerized Talking Touchscreen Not Applicable

Detailed Description:

Low health literacy as a barrier to healthcare. Health literacy is defined as "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions." A vast body of research shows that lower health literacy is associated with poorer outcomes, including higher hospitalization rates, worse health, and greater mortality. Approximately 75 million U.S. adults have low health literacy. Worse yet, racial and ethnic minorities and older individuals (age 65+) are more likely to have low health literacy, creating another mechanism for health disparities. These data indicate that many people will have difficulties adhering to treatment regimens that require health literacy, as well as completing questionnaires for public health and health research and care.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a two-group, three time-point experimental design. The two study groups are paper-and-pencil questionnaires versus a computerized talking touchscreen interface. The three time points are baseline, 3-month follow-up, and 6-month follow-up.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reducing Assessment Barriers for Patients With Low Health Literacy
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
No Intervention: Pen-and-paper format
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
Experimental: 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.

Other: 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.





Primary Outcome Measures :
  1. The degree of differential item functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) [ Time Frame: 6 months ]

    A primary outcome of this study will be the degree of DIF in NIH PROMIS questionnaires observed across adequate versus low health literacy.

    The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item.

    PROMIS has the following subscales: Physical function, Anxiety, Depression, Fatigue, Sleep disturbance, Ability to participate in social roles and activities, Pain interference, Pain intensity.

    For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the mean of the US population. Items are aggregated using item response theory, but aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item.

    Pain intensity will not be included because it is only 1 item and is not amenable to DIF.


  2. The degree of differential item functioning (DIF) in the Berlin Questionnaire (sleep) [ Time Frame: 6 months ]

    A primary outcome of this study will be the degree of DIF observed in the Berlin Questionnaire across adequate versus low health.

    The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item.

    For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation.

    Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.


  3. NIH Toolbox - Meaning and Purpose [ Time Frame: 6 months ]

    A primary outcome of this study will be the degree of DIF observed in the NIH Toolbox - Meaning and Purpose questionnaire across adequate versus low health literacy, determined by Health LiTT.

    The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item.

    For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation.

    Normally items are aggregated by a score determined by an item response theory scoring algorithm using a two-parameter model. It should be noted that the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.

    By convention NIH Toolbox scores are rescaled to T scores (mean = 50, Standard Deviation (SD) = 10 by definition), referenced against the mean of the US population.


  4. Posttraumatic Stress Disorder Checklist (PTSD Checklist/PCL-5) [ Time Frame: 6 months ]

    A primary outcome of this study will be the degree of DIF observed in the PCL-5 (PTSD checklist) across adequate versus low health literacy, determined by the Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT). The PCL-5 is a questionnaire used to determine the presence of PTSD and severity of PTSD.

    The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item.

    For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation.

    Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.


  5. Ruminative Responses Scale (RRS; 10-item version) [ Time Frame: 6 months ]

    A primary outcome of this study will be the degree of DIF observed in the RRS across adequate versus low health literacy, determined by Health LiTT. The RRS is a questionnaire used to quantify the degree to which the participant ruminates.

    The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item.

    For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation.

    Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.


  6. Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]

    A primary outcome of this study will be the degree of DIF observed in the Patient Health Questionnaire (PHQ-9), a questionnaire used to measure depression, across adequate versus low health literacy.

    The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item.

    For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation.

    Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.


  7. Exit interview: Participant comfort during assessment [ Time Frame: 6 months ]

    At the end of the 6-month study, each participant will provide information about their experience during testing. There are about 1) Comfort, 2) Difficulty, and 3) Nervousness.

    Each items is rated on a 5-point scale. Investigators will treat these data as ordinal and thus no unit of measure is assumed. Investigators will evaluate this outcome using non-parametric statistics, that is, a Spearman correlation between rating and whether the participant received the talking touchscreen (coded 0 or 1).

    These items will be administered verbally by a research coordinator.

    Investigators predict that participant's receiving the talking touchscreen will report high levels of comfort, less difficulty, and less nervousness. Investigators will evaluate statistical significance using a 99% confidence interval, rejecting the null hypothesis if this interval does not contain zero.

    The items will not be aggregated; each item will be analyzed separately.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 18 years of age or older
  • 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:

  • Significant cognitive or neurologic impairment
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584490


Contacts
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Contact: James Griffith, PhD 312-503-5345 j-griffith@northwestern.edu
Contact: Eloisa Serrano, MA 312-503-6501 eloisa.serrano@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: James Griffith, PhD    312-503-5345    j-griffith@northwestern.edu   
Contact: Eloisa Serrano, MA    312-503-6501    eloisa.serrano@northwestern.edu   
Sponsors and Collaborators
Northwestern University
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: James Griffith, PhD Northwestern University
  Study Documents (Full-Text)

Documents provided by James W Griffith, Northwestern University:
Study Protocol  [PDF] May 24, 2018
Informed Consent Form  [PDF] November 20, 2018
Statistical Analysis Plan  [PDF] March 27, 2019


Publications of Results:
Other Publications:

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Responsible Party: James W Griffith, Research Assistant Professor of Medical Social Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT03584490     History of Changes
Other Study ID Numbers: STU00202907
1R01MD010440-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No