DiabetesASL-ADENCT03980808
American Sign Language-Accessible Diabetes Education
A study testing American Sign Language-Accessible Diabetes Education in people with Diabetes and Deafness, run by Georgia Institute of Technology at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- What is being tested?
- American Sign Language-Accessible Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2020to 26 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Deaf
- Primary language is American Sign Language
- Approximately one-half of the sample must have a diabetes diagnosis.
Who cannot join
- Minors
- People whose primary language is not ASL
- Individuals unable to provide consent due to impaired decision-making
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Advanced Communications Policy
Atlanta, Georgia, 30332
Deaf Link, Inc.
San Antonio, Texas, 78232
About this study
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.
Read the 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.
- Being tested
- American Sign Language-Accessible Diabetes Education, Control Intervention
- Keywords
- Diabetes, Deafness
- Medical subject headings
- Diabetes Mellitus, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Sign Language-Accessible Diabetes EducationBehavioural
Also called ASL-ADE
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 InterventionBehavioural
Non-health related video approximately the same length as ASL-ADE.
| Study group | Role | What they receive |
|---|---|---|
| ASL-ADE Intervention Arm | Experimental | One-half of enrolled participants will view the ASL-ADE video intervention. Receives: Behavioral: American Sign Language-Accessible Diabetes Education |
| Control Arm | Sham comparator | One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention. Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The outcome measure results for the Your Health Behaviors measure are a comparison between the pretest and the 30-day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start29 Oct 2020
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muslimah "Salimah" S LaForce, Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980808
- Sponsor's protocol ID
- H19229
- Other IDs
- 5P30DK111024-04
- Acronym
- ASL-ADE
- Status last verified
- Aug 2022
- First submitted
- 6 Jun 2019
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Sign Language-Accessible Diabetes Education
- ClinicalTrials.gov ID
- NCT03980808
- Acronym / sponsor ID
- ASL-ADE / H19229
- Keywords
- Diabetes, Deafness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Posted 27 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASL-ADE Intervention Arm | Experimental | Behavioral: American Sign Language-Accessible Diabetes EducationOne-half of enrolled participants will view the ASL-ADE video intervention. |
| Control Arm | Sham comparator | Behavioral: Control InterventionOne-half of enrolled participants will view a non-health related video approximately the same length as the video intervention. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Deaf
- Primary language is American Sign Language
- Approximately one-half of the sample must have a diabetes diagnosis.
Key exclusion criteria (3 listed)
- Minors
- People whose primary language is not ASL
- Individuals unable to provide consent due to impaired decision-making
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American Sign Language-Accessible Diabetes EducationAlso: ASL-ADEVideo-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. | Behavioural | ASL-ADE Intervention Arm |
| Control InterventionNon-health related video approximately the same length as ASL-ADE. | Behavioural | Control Arm |
Primary outcome
Diabetes Health Literacy Score
Time frame: The 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 Behaviors
Time frame: The 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muslimah "Salimah" S LaForce principal investigator
Georgia Institute of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing American Sign Language-Accessible Diabetes Education in people with Diabetes and Deafness, run by Georgia Institute of Technology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Health Literacy Score (time frame: The outcome measure results reflect a comparison of the pre and posttest immediate scores.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.