An interventional study of American Sign Language-Accessible Diabetes Education and Control Intervention in Diabetes and Deafness, sponsored by Georgia Institute of Technology. Completed at 2 sites in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Georgia Institute of Technology · Not applicable, Interventional, and Other
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.
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.
609 studies on the registry are indexed under Deafness; 111 are open to participants now.
This study's enrollment of 41 is close to the median of 40 across 411 interventional studies indexed under Deafness.
Browse Deafness studies →Georgia Institute of Technology is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One-half of enrolled participants will view the ASL-ADE video intervention.
Behavioral: American Sign Language-Accessible Diabetes Education
One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention.
Behavioral: Control 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.
Also known as: ASL-ADE
Non-health related video approximately the same length as ASL-ADE.
Diabetes Health Literacy Score
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.
Time frame: The outcome measure results reflect a comparison of the pre and posttest immediate scores.
Frequency of Engagement in Diabetes-Related Health Behaviors
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.
Time frame: The outcome measure results for the Your Health Behaviors measure are a comparison between the pretest and the 30-day follow-up.
Participant recruitment began on October 27, 2020. Participants were recruited from DeafLink's nationwide reach into the Deaf community.
| Milestone | ASL-ADE Intervention Arm | Control Arm |
|---|---|---|
| Started | 24 | 17 |
| Phase 2 - 30-day follow-up | 24 | 17 |
| Completed | 22 | 15 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
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.
| score on a scale | ASL-ADE Intervention Arm | Control Arm |
|---|---|---|
| Diabetes Health Literacy Score | 1.30 (-.05 to 2.65) | 1.38 (-1.15 to 3.90) |
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.
| score on a scale | ASL-ADE Intervention Arm | Control Arm |
|---|---|---|
| Frequency of Engagement in Diabetes-Related Health Behaviors | .2381 (-1.1343 to 2.6205) | 2.0625 (0.2532 to 3.8718) |
Collected over 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASL-ADE Intervention Arm | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Control Arm | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
Adults who are Deaf and whose primary language is Americal Sign Language (ASL), some with a diabetes diagnosis and some without. Participants were randomly assigned to either an intervention group or a control group.
| Age, Categorical(Participants) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 15 | 35 |
| >=65 years | 4 | 2 | 6 |
| Age, Continuous(Years) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 52.42 ± 12.33 | 50.47 ± 12.76 | 51.6 ± 12.4 |
| Sex/Gender, Customized(Participants) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 14 | 12 | 26 |
| Non-Binary | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Asian or Indian | 5 | 2 | 7 |
| Black, African American, or West Indian | 3 | 2 | 5 |
| Hispanic, Latino or Spanish Origin, regardless of race | 5 | 4 | 9 |
| More than one race | 4 | 5 | 9 |
| White or Caucasian | 7 | 4 | 11 |
| Region of Enrollment(participants) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| United States | 24 | 17 | 41 |
| Deaf(Participants) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Count of participants | 24 | 17 | 41 |
| Diabetes Diagnosis (Yes)(Participants) | ASL-ADE Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Count of participants | 11 | 9 | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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Georgia Institute of Technology