American Sign Language-Accessible Diabetes Education

NCT ID: NCT03980808

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-29
• Study Completion Date: 2021-01-26

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.

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.

Conditions

Diabetes; Deafness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ASL-ADE Intervention Arm

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

Group Type: EXPERIMENTAL

American Sign Language-Accessible Diabetes Education

Intervention Type: BEHAVIORAL

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.

Control Arm

One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention.

Group Type: SHAM_COMPARATOR

Control Intervention

Intervention Type: BEHAVIORAL

Non-health related video approximately the same length as ASL-ADE.

Interventions

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.

Intervention Type: BEHAVIORAL

Control Intervention

Non-health related video approximately the same length as ASL-ADE.

Intervention Type: BEHAVIORAL

Other Intervention Names

ASL-ADE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Georgia Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muslimah "Salimah" S LaForce

Role: PRINCIPAL_INVESTIGATOR

Georgia Institute of Technology

Locations

Center for Advanced Communications Policy

Atlanta, Georgia, United States

Deaf Link, Inc.

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P30DK111024-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H19229

Identifier Type: -

Identifier Source: org_study_id