Trial Outcomes & Findings for American Sign Language-Accessible Diabetes Education (NCT NCT03980808)
NCT ID: NCT03980808
Last Updated: 2023-07-10
Results Overview
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.
COMPLETED
NA
41 participants
The outcome measure results reflect a comparison of the pre and posttest immediate scores.
2023-07-10
Participant Flow
Participant recruitment began on October 27, 2020. Participants were recruited from DeafLink's nationwide reach into the Deaf community.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
17
|
|
Overall Study
Phase 2 - 30-day Follow-up
|
24
|
17
|
|
Overall Study
COMPLETED
|
22
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
American Sign Language-Accessible Diabetes Education
Baseline characteristics by cohort
| Measure |
ASL-ADE Intervention Arm
n=24 Participants
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.
|
Control Arm
n=17 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
52.42 Years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
50.47 Years
STANDARD_DEVIATION 12.76 • n=7 Participants
|
51.6 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Indian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, African American, or West Indian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino or Spanish Origin, regardless of race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
17 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Deaf
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Diabetes Diagnosis (Yes)
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ASL-ADE Intervention Arm
n=24 Participants
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.
|
Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Diabetes Health Literacy Score
|
1.30 score on a scale
Interval -0.05 to 2.65
|
1.38 score on a scale
Interval -1.15 to 3.9
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
ASL-ADE Intervention Arm
n=24 Participants
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.
|
Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Frequency of Engagement in Diabetes-Related Health Behaviors
|
.2381 score on a scale
Interval -1.1343 to 2.6205
|
2.0625 score on a scale
Interval 0.2532 to 3.8718
|
Adverse Events
ASL-ADE Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place