Improving Diabetic Patient Health Through Assistive-Reading Technology

Sponsor
GogyUp Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05337306
Collaborator
University of Minnesota (Other)
160
2
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: GogyUp Reader
Phase 1

Detailed Description

Diabetes self-management requires knowledgeable communication and capacity for self-management. People with type 2 diabetes mellitus (T2DM) must learn from health care providers about the condition to build knowledge on how to manage the disease and competently carry out self-management. T2DM self-management is extensive: estimates of time spent on recommended self-management activities can exceed 10 hours per week, equivalent to part-time employment. Effective T2DM-related self-management requires patients to read, understand, and execute care plans. In short, T2DM comes with a demanding workload that assumes patients have enough capacity to read and follow complex instructions to successfully manage their disease.

Barriers to building understanding and competence for self-management both reflect and contribute significantly to inequality. Existing social systems in the United States have provided inequitable educational achievement, including literacy in general and health literacy in particular. The result is that the U.S. has widespread and entrenched adult illiteracy. 18% of U.S. adults (roughly 44 million) are unable to decipher unfamiliar words or identify information in short texts. In practical terms, a large segment of the U.S. population is without the skills to read medicine or nutrition labels, follow written aftercare instructions, etc. This deficit is reflected in the T2DM patient population. Large percentages (e.g., 35-55%) of individuals with T2DM have reading levels at 6th grade or below, with lower literacy significantly associated with several demographic variables (e.g., lower socioeconomic status), indicating inequitable distribution. Moreover, lower functional English and health literacy, and poorer diabetes knowledge, are associated with poorer glycemic control.

However, work on facilitating the entry of adults with limited literacy and English proficiency into the workforce demonstrates that these challenges can be successfully addressed through an integrated adult literacy approach. This approach of "integrated adult literacy" combines the delivery and understanding of concepts and information with in-the-moment assistive-reading technology and contextualized literacy instruction regardless of whether an adult employee is correctly perceived to be at risk for missing critical information.

Health care supports for capacity in self-management lack appreciation for integrated adult literacy and have limited effectiveness. Health literacy is not only an individual issue, but also reflects if systems and materials are calibrated to individual capacity. Yet health care does not typically operate in recognition of this fact. Written patient materials for post-visit care are consistently complex, often far exceeding the intended consuming audience's reading level. Meanwhile, practices such as "Teach Back" and including interpreters in clinic visits have short-term benefits for patient understanding and ability to carry out self-management; as these effects diminish over time, mastery of key information becomes elusive. The inadequacy of these measures is compounded by stigma that can accompany low literacy or limited English proficiency. Even patients who have developed literacy skills may be embarrassed about a lack of understanding. Stigma, embarrassment, or simply the stress of a clinical appointment can prevent patients from asking clarifying or follow-up questions, a process integral to establishing content mastery.

Existing systems are inadequate to bridging gaps in patients' needs and readiness to manage diabetes. Achieving universal literacy in the U.S. adult population historically has been a major challenge; systems in place lack sufficient system capacity and scale to address it. For example, only a fraction of U.S. adults in need of reading instruction have access to it. Literature indicates a growing recognition by health educators of the potential for engaging with and implementing techniques from adult basic education, including integrated adult literacy. However, significant factors would still limit the impact which implementing such measures could have for patients with limited literacy or English proficiency. Foremost would be the significant issue of scale needed for impact and improvement.

A paradigm shift is needed, from clinic-by-clinic intervention to highly scalable, low cost in-the-moment support using assistive technology (AT) but little is known, particularly from an integrated adult literacy perspective. As noted, existing systems are inadequate to increase integrated adult literacy generally, and clinical interventions require patients to retain knowledge as they use complex, written instructions and education materials in self-management away from the clinic. Because changes to these have historically remained out of reach, the investigators propose shifting the paradigm away from focusing on providers' capacity to communicate and educate, and toward supporting patients' capacity to access, comprehend and internalize health education through AT, expanding their capacity for self-management in the moment, on an as-needed basis. AT commonly refers to any equipment, software, etc. that is used to maintain or improve the functional capabilities of individuals with disabilities, often with features and functions that can be adjusted to an individual's specific requirements. Notably, existing electronic health (eHealth) and mobile health (mHealth) support technologies with text-heavy interfaces have not incorporated reading AT and are frequently limited to single-use applications with poor readability, and/or usability issues, negating their benefit for integrated adult literacy for diabetes self-care.

Substantial evidence describes how AT equalizes information access across education levels. When combined with the near-ubiquity of mobile devices and telecommunications networks, AT - and specifically assistive reading technology - holds the potential for universal, integrated adult literacy supports that could substantially impact diabetes self-management education. Sidewalk cutouts offer a useful analogy for whole-population benefit. While cutouts expand mobility to those using walkers and wheelchairs, they also provide unintended benefits to any child riding a bicycle or parent pushing a stroller. Similarly, benefits from reading AT could extend beyond the intended population (e.g., adults with limited functional literacy or English proficiency) to those with diminished eyesight and even fully literate adults simply struggling with difficult materials.

Contribution: Understanding use and potential benefit of in-the-moment reading support for adult patients in understanding diabetes self-management written materials. The potential benefit of reading AT, readily embedded in adult patients' lives, that expands their capacity to use written materials at scale, at low cost, and particularly from an integrated adult literacy standpoint, has not been previously studied.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Increasing Health Equity Through In-The-Moment Reading Assistance for Adults With Diabetes Served at Community Health Centers
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GogyUp

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
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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline of Functional Health Literacy (FHL) Subscale of All Aspects of Health Literacy Scale (AAHLS) [3 - 6 months]

    The primary outcome measure is the three-month (follow up) value of the Functional Health Literacy (FHL) validated subscale of the All Aspects of Health Literacy Scale (AAHLS). Functional health literacy refers to the ability to use and understand health-related materials. The FHL measure is a continuous variable that is the sum of the three subscale items (Crohnbach's alpha=.82 in initial validation study). This study's main objective is to study the effect of GogyUp on functional 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 FHL subscale is the most 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.

Secondary Outcome Measures

  1. Change from Baseline of Communicative Health Literacy (CHL) Subscale of All Aspects of Health Literacy Scale (AAHLS) [3 - 6 months]

    The secondary outcome measurement is the three-month (follow up) values of the validated subscale of Communicative Health Literacy (CHL) - how well one can communicate with about conditions and their management - and the full All Aspects of Health Literacy Scale (AAHLS) score itself. The communicative health literacy measure, as well as the overall all aspects of health literacy scale, are dimensions of health literacy which are less proximal to the intervention but reflect broader mastery in health literacy. Functional health literacy (primary outcome, the ability to use/understand written health information) is a foundational hurdle to these other, broader domains of health literacy. While our focus is that most proximal outcome focused on success in using/understanding written materials (primary endpoint), secondary endpoints will indicate whether GogyUp Reader has broader effects.

Other Outcome Measures

  1. Change from Baseline Value of A1c (HbA1c) [3 - 6 months]

    The third outcome is three-month (follow-up) value of hemoglobin A1c (HbA1c; diabetes control measure). Hemoglobin A1c is a distal, but important outcome representing control of diabetes. While the current trial is too small to expect sufficient power to study this outcome due to its distal (from the intervention) nature, we will obtain effect size estimates for use in powering a larger trial in the future. It is expected that diabetes control (measured as hemoglobin A1c) will be the most directly related distal outcome of improved diabetes health literacy improvements and thus represents a final endpoint of clinical importance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Provision of signed and dated informed consent form

  2. Males and females; Aged 18-85 years

  3. Documented diagnosis of type II diabetes mellitus

  4. Has had a visit to a clinic in the past year (April 2020-February 2021); can include a telehealth visit

  5. Receives patient education materials and can consent in English

Exclusion Criteria:
  1. Currently enrolled in another treatment or intervention study (at pre-screen)

  2. Pregnancy (because pregnancy becomes the primary condition of interest)

  3. Note: Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) will not be a criterion.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GogyUp Inc
  • University of Minnesota

Investigators

  • Principal Investigator: Ned Zimmerman-Bence, GogyUp Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GogyUp Inc
ClinicalTrials.gov Identifier:
NCT05337306
Other Study ID Numbers:
  • 1R43NR020340
First Posted:
Apr 20, 2022
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GogyUp Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2022