Reducing Assessment Barriers for Patients With Low Literacy
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| ClinicalTrials.gov Identifier: NCT03584490 |
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Recruitment Status :
Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : March 30, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Health Literacy | Other: Computerized Talking Touchscreen Other: Phone Administration of Questionnaires | Not Applicable |
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.
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 729 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. Additionally, due to the COVID-19 pandemic, participants can optionally enroll in a phone-based assessment that includes 3 time-points over 6 months. |
| 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 : | July 1, 2023 |
| Estimated Study Completion Date : | July 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Pen-and-paper format
Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.
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Other: Phone Administration of Questionnaires
This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. |
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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. Other: Phone Administration of Questionnaires This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Phone-based protocol:
Inclusion criteria:
- Enrollment in the in-person protocol (including all inclusion/exclusion criteria from in-person protocol)
- Access to reliable phone connection
- Be willing to participant in three phone-based sessions
Exclusion criteria:
- Unable to complete the consent process
- Inadequate hearing for phone-based assessments
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
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | James Griffith, PhD | Northwestern University |
Documents provided by James W Griffith, Northwestern University:
Other Publications:
| Responsible Party: | James W Griffith, Research Assistant Professor of Medical Social Sciences, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT03584490 |
| Other Study ID Numbers: |
STU00202907 1R01MD010440-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 12, 2018 Key Record Dates |
| Last Update Posted: | March 30, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |