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American Sign Language-Accessible Diabetes Education

American Sign Language-Accessible Diabetes Education

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03980808
Acronym
ASL-ADE
Enrollment
41
Registered
2019-06-10
Start date
2020-10-29
Completion date
2021-01-26
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness, Diabetes

Keywords

Diabetes, Deafness

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.

Interventions

BEHAVIORALAmerican 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.

BEHAVIORALControl Intervention

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

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Georgia Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Diabetes Health Literacy ScoreThe 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.
Frequency of Engagement in Diabetes-Related Health BehaviorsThe 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.

Countries

United States

Participant flow

Recruitment details

Participant recruitment began on October 27, 2020. Participants were recruited from DeafLink's nationwide reach into the Deaf community.

Participants by arm

ArmCount
ASL-ADE Intervention Arm
One-half of enrolled participants will view the ASL-ADE video intervention. 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.
24
Control Arm
One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention. Control Intervention: Non-health related video approximately the same length as ASL-ADE.
17
Total41

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22

Baseline characteristics

CharacteristicASL-ADE Intervention ArmControl ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants2 Participants6 Participants
Age, Categorical
Between 18 and 65 years
20 Participants15 Participants35 Participants
Age, Continuous52.42 Years
STANDARD_DEVIATION 12.33
50.47 Years
STANDARD_DEVIATION 12.76
51.6 Years
STANDARD_DEVIATION 12.4
Deaf24 Participants17 Participants41 Participants
Diabetes Diagnosis (Yes)11 Participants9 Participants20 Participants
Race/Ethnicity, Customized
Asian or Indian
5 Participants2 Participants7 Participants
Race/Ethnicity, Customized
Black, African American, or West Indian
3 Participants2 Participants5 Participants
Race/Ethnicity, Customized
Hispanic, Latino or Spanish Origin, regardless of race
5 Participants4 Participants9 Participants
Race/Ethnicity, Customized
More than one race
4 Participants5 Participants9 Participants
Race/Ethnicity, Customized
White or Caucasian
7 Participants4 Participants11 Participants
Region of Enrollment
United States
24 participants17 participants41 participants
Sex/Gender, Customized
Female
9 Participants5 Participants14 Participants
Sex/Gender, Customized
Male
14 Participants12 Participants26 Participants
Sex/Gender, Customized
Non-Binary
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 17
other
Total, other adverse events
0 / 240 / 17
serious
Total, serious adverse events
0 / 240 / 17

Outcome results

Primary

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.

Population: Group 1 and Group 2 consisted of adults with and without diabetes who primarily use American Sign Language (ASL) for Communication

ArmMeasureValue (MEAN)
ASL-ADE Intervention ArmDiabetes Health Literacy Score1.30 score on a scale
Control ArmDiabetes Health Literacy Score1.38 score on a scale
Comparison: Composite scores were calculated for the knowledge based tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.p-value: 0.95ANOVA
Primary

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.

Population: The population consists of people with and without Diabetes who were Deaf who rely on ASL for communication.

ArmMeasureValue (MEAN)
ASL-ADE Intervention ArmFrequency of Engagement in Diabetes-Related Health Behaviors.2381 score on a scale
Control ArmFrequency of Engagement in Diabetes-Related Health Behaviors2.0625 score on a scale
Comparison: Composite scores were calculated for the behavioral self-report tests tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.p-value: 0.093ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026