ASL-ADE: American Sign Language-Accessible Diabetes Education

Sponsor
Georgia Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT03980808
Collaborator
(none)
41
2
2
2.9
20.5
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: American Sign Language-Accessible Diabetes Education
  • Behavioral: Control Intervention
N/A

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 age and diagnosis status to measure if variance in scores are related to age, with a specific interest in transition aged (18-30) 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Solomon Four-Group Design will be used to distinguish intervention effects from pretest effects. There will be two intervention groups and two control groups as detailed below: Intervention Group 1 will (a) take the pretest, (b) view the video intervention, (c) immediately following the intervention take the posttest, and (d) 30-days following take the posttest. Control Group 1 will (a) take the pretest (b) view a non-health related video approximately the same length as the video intervention, and (c) take the posttest at the 30-day follow-up posttest. Intervention Group 2 will (a) view the video intervention, (b) immediately following the intervention take the posttest, and (d) 30-days following take the posttest. Group 2 will (a) take the posttest and (b) 30-days following, take the posttest. For those that are assigned to the control groups, at the completion of the study they will be offered the opportunity to view the ASL-ADE interventionSolomon Four-Group Design will be used to distinguish intervention effects from pretest effects. There will be two intervention groups and two control groups as detailed below:Intervention Group 1 will (a) take the pretest, (b) view the video intervention, (c) immediately following the intervention take the posttest, and (d) 30-days following take the posttest. Control Group 1 will (a) take the pretest (b) view a non-health related video approximately the same length as the video intervention, and (c) take the posttest at the 30-day follow-up posttest. Intervention Group 2 will (a) view the video intervention, (b) immediately following the intervention take the posttest, and (d) 30-days following take the posttest. Group 2 will (a) take the posttest and (b) 30-days following, take the posttest. For those that are assigned to the control groups, at the completion of the study they will be offered the opportunity to view the ASL-ADE intervention
Masking:
Single (Participant)
Masking Description:
Participants will not know until the conclusion of the study if they were in the intervention group or the control group. Those on the control group will be offered the opportunity to view the video intervention when data collection concludes.
Primary Purpose:
Other
Official Title:
American Sign Language-Accessible Diabetes Education
Actual Study Start Date :
Oct 29, 2020
Actual Primary Completion Date :
Jan 26, 2021
Actual Study Completion Date :
Jan 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASL-ADE Intervention Arm

One-half of enrolled participants will view the ASL-ADE video intervention.

Behavioral: American Sign Language-Accessible Diabetes Education
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.

    Behavioral: Control Intervention
    Non-health related video approximately the same length as ASL-ADE.

    Outcome Measures

    Primary Outcome Measures

    1. Diabetes Health Literacy Score [3 months]

      Data will be collected using study-specific questionnaires that measure diabetes knowledge. They will be forced choice, closed-ended questions to allow for a total score ranging from 0 correct to all correct.

    2. Frequency of Engagement in Diabetes-Related Health Behaviors [3 months]

      Data will be collected using study-specific questionnaires that measure frequency of diabetes-related health behaviors (e.g., vegetable, whole grains, and fruit intake; dietary fat intake, alcohol intake, smoking, exercise, and regular healthcare maintenance such as having an annual physical).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Advanced Communications Policy Atlanta Georgia United States 30332
    2 Deaf Link, Inc. San Antonio Texas United States 78232

    Sponsors and Collaborators

    • Georgia Institute of Technology

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Georgia Institute of Technology
    ClinicalTrials.gov Identifier:
    NCT03980808
    Other Study ID Numbers:
    • H19229
    First Posted:
    Jun 10, 2019
    Last Update Posted:
    Feb 4, 2021
    Last Verified:
    Feb 1, 2021
    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 Georgia Institute of Technology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2021