American Sign Language-Accessible Diabetes Education (ASL-ADE)
Primary Purpose
Diabetes, Deafness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
American Sign Language-Accessible Diabetes Education
Control Intervention
Sponsored by
About this trial
This is an interventional other trial for Diabetes focused on measuring Diabetes, Deafness
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
Sites / Locations
- Center for Advanced Communications Policy
- Deaf Link, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
ASL-ADE Intervention Arm
Control Arm
Arm Description
One-half of enrolled participants will view the ASL-ADE video intervention.
One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03980808
First Posted
June 6, 2019
Last Updated
July 6, 2023
Sponsor
Georgia Institute of Technology
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03980808
Brief Title
American Sign Language-Accessible Diabetes Education
Acronym
ASL-ADE
Official Title
American Sign Language-Accessible Diabetes Education
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
January 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgia Institute of Technology
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Deafness
Keywords
Diabetes, Deafness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASL-ADE Intervention Arm
Arm Type
Experimental
Arm Description
One-half of enrolled participants will view the ASL-ADE video intervention.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention.
Intervention Type
Behavioral
Intervention Name(s)
American Sign Language-Accessible Diabetes Education
Other Intervention Name(s)
ASL-ADE
Intervention Description
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
Intervention Name(s)
Control Intervention
Intervention Description
Non-health related video approximately the same length as ASL-ADE.
Primary Outcome Measure Information:
Title
Diabetes Health Literacy Score
Description
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.
Title
Frequency of Engagement in Diabetes-Related Health Behaviors
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muslimah "Salimah" S LaForce
Organizational Affiliation
Georgia Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Advanced Communications Policy
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
Facility Name
Deaf Link, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will become available immediately following publication and with no end date.
IPD Sharing Access Criteria
The data and supporting information will be shared 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 (Link to be included).
Learn more about this trial
American Sign Language-Accessible Diabetes Education
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