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Improving Diabetic Patient Health Through Assistive-Reading Technology

NCT05337306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2025-01-01

Study results available
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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).

Conditions

  • Diabetes Mellitus, Type 2
  • Health Knowledge, Attitudes, Practice
  • Literacy

Interventions

OTHER

GogyUp Reader

Participants will have unlimited access to the assistive-reading technologies available in the GogyUp Reader app for help understanding post-visit educational documents on type 2 diabetes mellitus disease management.

Sponsors & Collaborators

Principal Investigators

  • Ned Zimmerman-Bence · GogyUp Inc

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-06-12
Completion
2024-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05337306 on ClinicalTrials.gov