American Sign Language-Accessible Diabetes Education (ASL-ADE)

July 6, 2023 updated by: Georgia Institute of Technology
ASL-ADE will evaluate the efficacy of an ASL-interpreted diabetes educational intervention to the end of improving the health literacy of the target population and addressing their disparate health outcomes.

Study Overview

Detailed Description

Georgia Tech's Center for Advanced Communications Policy (CACP) proposes the American Sign Language Accessible Diabetes Education (ASL-ADE) project in response to the Georgia Center for Diabetes Translation Research for a pilot and feasibility study on "Type II translation research in diabetes care and prevention." ASL-ADE will conduct an efficacy study, in the Engagement and Behavior Change Core, with the long-term objective of improved health outcomes for individuals who are Deaf and primarily communicate using ASL. The project will demonstrate the need for diabetes educational materials to be accessible to people who are Deaf and rely on ASL for clear and effective communications. ASL is a distinct language used by individuals of the Deaf community and is grammatically dissimilar to English. Some people who are Deaf rely primarily on ASL and have limited English proficiency. , Other people who are deaf are comfortable with written English. Due to the language diversity within this community, diabetes health education materials are not always accessible. For example, there are low levels of general health literacy among people who are Deaf which increases risk for developing chronic illnesses, , , including diabetes. As such, people who are Deaf also have an increased risk for acute complications associated with diabetes. The low level of health literacy among the target population is directly related to communication/language barriers, as much of the health education outreach mechanisms are exclusionary because of their use of audio and print materials. The hearing population can benefit from incidental learning such as overhearing conversations and watching the news, even commercials. It is a form of socialization that is often taken for granted by people who can hear. To address this access gap, the goals of ASL-ADE are to provide accessible materials to improve health literacy and (1) impact awareness of risk factors, preventive measures, and diabetes symptoms, and (2) elicit the desired behavioral response to seek medical care and modify health-related behaviors. The proposed project will produce a video-based ASL interpreted diabetes educational intervention, and using a pretest-posttest (immediate) 30-day posttest quasi-experimental design, evaluate the effect of the educational intervention on knowledge about diabetes and related health behavior changes. Data will be analyzed along the dimensions of diagnosis status to measure if there is variance in scores for people who are Deaf with a diabetes diagnosis compared to their non-diagnosed counterparts; the a priori hypothesis being that given the communication barriers experienced by people who are Deaf, that no significant between-group differences will be found on pretest scores based on diagnosis status.

This description is revised to exclude analysis along the dimensions of age because our sample did not contain enough subjects between the ages of 18-30 to run a comparison.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30332
        • Center for Advanced Communications Policy
    • Texas
      • San Antonio, Texas, United States, 78232
        • Deaf Link, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years old or older
  • Deaf
  • Primary language is American Sign Language
  • Approximately one-half of the sample must have a diabetes diagnosis.

Exclusion Criteria:

  • Minors
  • People whose primary language is not ASL
  • Individuals unable to provide consent due to impaired decision-making

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASL-ADE Intervention Arm
One-half of enrolled participants will view the ASL-ADE video intervention.
Video-based ASL interpreted diabetes educational intervention (ASL-ADE), the content of which will be derived from diabetes health information regarding symptoms and risk factors that are published by the U.S. Centers for Diseases Control and Prevention (CDC) and the National Institute for Health (NIH) National Diabetes Education Program.
Other Names:
  • ASL-ADE
Sham Comparator: Control Arm
One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention.
Non-health related video approximately the same length as ASL-ADE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Health Literacy Score
Time Frame: The outcome measure results reflect a comparison of the pre and posttest immediate scores.
Data were collected using a study-specific, knowledge-based Diabetes Health Literacy measure which included 15 forced-choice, closed-ended questions to allow for a total score ranging from 0 to 15, with higher scores reflecting better diabetes health literacy. Analysis of change of knowledge compared differences between the intervention arm and the control arm as measured by the changes to the composite scores of the knowledge-based test. One factor Analysis of Variance (ANOVA) was used to calculate the differences with an a priori alpha level of 0.05.
The outcome measure results reflect a comparison of the pre and posttest immediate scores.
Frequency of Engagement in Diabetes-Related Health Behaviors
Time Frame: The outcome measure results for the Your Health Behaviors measure are a comparison between the pretest and the 30-day follow-up.
Data were collected using a study-specific questionnaire titled Your Health Behaviors that measure the frequency of diabetes-related health behaviors for a total score ranging from 7 to 35. Each of the diabetes behaviors (physical activity, work physical activity, cigarettes, smoking cessation, alcohol consumption, vegetable consumption, fruit consumption, grain consumption, junk food consumption, fast food consumption) had multiple choice answers that were scaled from 1 - n, with n being the number of options. The least healthy choice was assigned "1", the most healthy choice was assigned "n". Analysis of change in behavior compared differences between the intervention arm and the control arm as measured by the changes in the composite scores of the behavioral intervention. One factor Analysis of Variance (ANOVA) was used to compare the differences with an a priori level of 0.05.
The outcome measure results for the Your Health Behaviors measure are a comparison between the pretest and the 30-day follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Muslimah "Salimah" S LaForce, Georgia Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2020

Primary Completion (Actual)

January 26, 2021

Study Completion (Actual)

January 26, 2021

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be submitted to the Inter-university Consortium for Political and Social Research (ICPSR) to allow open, equitable and effective use of the data. Within the ICPSR, we anticipate our data will closely align with existing collections related to Behavioral Sciences, Health Management and Policy, and Disability Concerns. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Other documents to be shared include the study protocol and statistical analysis. These items will be shared immediately following publication (and with no end date) with researchers who provide a methodologically sound proposal for the purpose of achieving the aims of the proposal. Proposals should be directed to salimah@cacp.gatech.edu. To gain access, data requestors will need to sign a data access agreement. Data are available at a third-party website.

IPD Sharing Time Frame

The data will become available immediately following publication and with no end date.

IPD Sharing Access Criteria

The data and supporting information will be shared with researchers who provide a methodologically sound proposal for the purpose of achieving the aims of the proposal. Proposals should be directed to salimah@cacp.gatech.edu. To gain access, data requestors will need to sign a data access agreement. Data are available at a third-party website (Link to be included).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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