N/A
N=193
Improving Diabetic Patient Health Through Assistive-Reading Technology
Diabetes Mellitus, Type 2 · Health Knowledge, Attitudes, Practice · Literacy
Bottom Line
View on ClinicalTrials.gov: NCT05337306 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Health Literacy Questionnaire Subscale 9: Understanding Health Information Well Enough to Know What to do — 4.2079; 4.31739 units on a scale — p=.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GogyUp Reader (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GogyUp Inc
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health Literacy Questionnaire Subscale 9: Understanding Health Information Well Enough to Know What to do |
4.2079; 4.31739 | .049 sig |
| PRIMARY Health Literacy Questionnaire Subscale 2: Having Sufficient Information to Manage my Health |
3.03465; 3.16304 | .040 sig |
| SECONDARY Perceived Diabetes Self-Management Scale Score |
24.3409; 24.8452 | .220 |
Summary
Type 2 Diabetes Mellitus (T2DM) affects over 30 million Americans and requires patients to competently manage their conditions at home. However, the majority of diabetes self-management education (DSME) and aftercare print materials remain overly complicated, with excessively high reading difficulty and fall short in supporting functional readiness for self- management at home, especially for the 18% of U.S. adults unable to read beyond a second-grade level. This project will determine the feasibility of implementing assistive reading technology, designed for patients with limited print or English proficiency, that will immediately expand patient capacity to understand DSME materials, increase T2DM self- management adherence and eventually reduce, at a scale, disparate outcomes in a chronic disease. It will use a small pilot trial design of the GogyUp Reader app to use with print materials versus print materials with no app support and test effects of GogyUp on three-month follow-up measures of health literacy (primary outcome) using the Health Literacy Questionnaire subscales 9 (Understanding health information well enough to know what to do") and 2 ("Having sufficient information to manage my health"); and on three-month follow-up self-reported diabetes management (secondary outcome) using the Perceived Diabetes Self-Management Scale (PDSMS).
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Males and females; Aged 18-85 years
- Documented diagnosis of type II diabetes mellitus
- Has had a visit to a clinic in the past year (April 2020-February 2021); can include a telehealth visit
- Receives patient education materials and can consent in English
Exclusion Criteria
- Currently enrolled in another treatment or intervention study (at pre-screen)
- Pregnancy (because pregnancy becomes the primary condition of interest)
- Note: Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) will not be a criterion.
Data sourced from ClinicalTrials.gov (NCT05337306). 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.