Clinical trial NCT03980808: American Sign Language-Accessible Diabetes Education
Official title: American Sign Language-Accessible Diabetes Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Deafness
Keywords: Diabetes
Deafness
Lead sponsor: Georgia Institute of Technology
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-06-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Quasi-experimental pre and post-test design. There will be one intervention group and one control group as detailed below:

The intervention group will take the pretest, view the video intervention, take the posttest, and at 30-days following take another posttest.

The control group will take the pretest and posttest, and at 30-days following take another 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.

The study model was revised to not use the Solomon-Four Group Design because the initial decision to use that design was to measure if there was a pre-test effect. There were no effects for the pre and post-test measures; therefore, we combined the arms into an intervention/no-intervention group, aligning with the primary outcome measures: (1) health literacy, and (2) related health behaviors. The original submission indicated a two-arm study, not a four-arm.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Diabetes Health Literacy Score
timeFrame: The outcome measure results reflect a comparison of the pre and posttest immediate scores.
measure: Frequency of Engagement in Diabetes-Related Health Behaviors
timeFrame: The outcome measure results for the Your Health Behaviors measure are a comparison between the pretest and the 30-day follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Advanced Communications Policy
state: Georgia
city: San Antonio
country: United States
facility: Deaf Link, Inc.
state: Texas
Study officials:
affiliation: Georgia Institute of Technology
name: Muslimah "Salimah" S LaForce
role: PRINCIPAL_INVESTIGATOR
References: