Clinical trial NCT03584490: Reducing Assessment Barriers for Patients With Low Literacy
Official title: Reducing Assessment Barriers for Patients With Low Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-07-12
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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

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.

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.

Eligibility 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

Phone-based protocol:

Inclusion criteria:

1. Enrollment in the in-person protocol (including all inclusion/exclusion criteria from in-person protocol)
2. Access to reliable phone connection
3. Be willing to participant in three phone-based sessions

Exclusion criteria:

1. Unable to complete the consent process
2. Inadequate hearing for phone-based assessments

Primary outcomes:
measure: The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Anxiety Subscale
timeFrame: 6 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Depression Subscale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: James Griffith, PhD
role: PRINCIPAL_INVESTIGATOR
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