NCT05337306Completed
Improving Diabetic Patient Health Through Assistive-Reading Technology
Increasing Health Equity Through In-The-Moment Reading Assistance for Adults With Diabetes Served at Community Health Centers
Source: ClinicalTrials.gov · Last updated 1 Jan 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 193 (actual)
- First submitted
- 21 Mar 2022
- Start date
- 26 Apr 2023
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- GogyUp Inc
- Diseases
- Type 2 diabetes
- NCT number
- NCT05337306
What you commit to
- Study type: Interventional
- Participants enrolled: 193
- From 26 Apr 2023 to the primary completion date, 12 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnancy (because pregnancy becomes the primary condition of interest)
Other
- Currently enrolled in another treatment or intervention study (at pre-screen)
- Note: Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) will not be a criterion.
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MHealth Fairview system Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.