N/A N=729 Randomized Basic Science

Reducing Assessment Barriers for Patients With Low Literacy

Health Literacy

Bottom Line

View on ClinicalTrials.gov: NCT03584490 ↗

Enrolled (actual)

729

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: 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 Pseudo-R2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Computerized Talking Touchscreen (Other); Phone Administration of Questionnaires (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Sep 2021

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

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.