Improving Diabetic Patient Health Through Assistive-Reading Technology

NCT05337306 | Completed Results

• 1 other identifier: 1R43NR020340
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adherence; adult; aftercare; chronic disease; diabetes mellitus; educational materials; health education; Limited English Proficiency; patient education; literacy; health literacy; assistive technology; health disparity

Outcome Measures

Primary Outcomes (2)

• Health Literacy Questionnaire Subscale 9: Understanding Health Information Well Enough to Know What to do

  The first primary outcome is three-month (follow up) value of the Health Literacy Questionnaire (HLQ) subscale 9: Understanding health information well enough to know what to do The "Understanding health information" subscale is a multi-item, validated subscale of the HLQ and a continuous variable. It is a 5-item subscale, with items scored 1-5 (with higher scores being better) and then mean-aggregated. This study's main objective is to study the effect of GogyUp on health literacy (the ability to use and understand written health information) as a proximal effect of support. The Understanding health information subscale is the most direct measure; three-month follow up reflects (a) brief follow-up in a pilot trial; and (b) this outcome is very proximal to the intervention.

  3 months

• Health Literacy Questionnaire Subscale 2: Having Sufficient Information to Manage my Health

  The other primary outcome measurement is the three-month (follow up) value of the validated Health Literacy Questionnaire Subscale 2: having sufficient information to manage my health. The "Having sufficient information" subscale is a multi-item, validated subscale of the HLQ and a continuous variable. It is a 4-item subscale, with items scored 1-4 (with higher scores being better) and then mean-aggregated. This study's main objective is to study the effect of GogyUp on health literacy (def: the ability to use and understand written health information) as a most proximal effect of in-the-moment support. As such, the Having sufficient information subscale is an additional direct measure; the three-month time frame reflects (a) a brief follow-up as part of a pilot trial; and (b) is reasonable because of the use of this proximal (to the intervention) outcome based on putative mechanisms.

  3 months

Secondary Outcomes (1)

• Perceived Diabetes Self-Management Scale Score

  3 months

Study Arms (2)

GogyUp

EXPERIMENTAL

Participants in the GogyUp arm will have the GogyUp Reader app preloaded on a cellular-enabled tablet with the same patient education documents as the Control arm. Patients will be able to use on-demand / in-the-moment assistive-reading technologies to understand any word or phrase: * Speech-to-Text * Word-by-Word Translation * Alternative Formatting * Simplified and Contextualized Definitions * No-Fail Comprehension Questions * Personalized Training in Phonemic Awareness

Other: GogyUp Reader

Control

NO INTERVENTION

Participants in the Standard Care arm will receive the standard after-visit patient education documents the clinics current provide for type 2 diabetes education and self-management.

Interventions

GogyUp Reader OTHER

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.

GogyUp

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GogyUp Inc: lead
• University of Minnesota: collaborator

Study Sites (1)

MHealth Fairview system

Minneapolis, Minnesota, 55454, United States

Location

Related Links

• Reference List for Improving Diabetic Patient Health Through Assistive-Reading Technology

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior; Literacy; Chronic Disease; Diabetes Mellitus; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Communication; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Ned Zimmerman-Bence, Co-Founder
• Organization: GogyUp

ned.zb@gogyup.com

6124605358

Study Officials

• Ned Zimmerman-Bence

  GogyUp Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 20, 2022
• Study Start: April 26, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 30, 2024
• Last Updated: January 1, 2025
• Results First Posted: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study data will be available once final report has been accepted by the National Institute for Nursing Research (the funding agency). Analytic date will remain available through the University of Minnesota's Clinical Data Repository managed by the University of Minnesota's Clinical and Translational Sciences Institute.
• Access Criteria: Criteria include employees of federal agencies or institutions of higher learning.

Locations

US (1)