N/A
Completed N=729
Reducing Assessment Barriers for Patients With Low Literacy
Health Literacy
Source: ClinicalTrials.gov NCT03584490 ↗
Enrolled (actual)
729
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Anxiety Subscale — 0.06; 0.02 Pseudo-R2
Summary
The purpose of this study is to determine the effects of health literacy on questionnaire-based measurement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Anxiety Subscale |
0.06; 0.02 | — |
| PRIMARY Patient Health Questionnaire (PHQ-9) |
0.00; 0.02 | — |
| PRIMARY The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Depression Subscale |
0.04; 0.04 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT03584490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.