NCT03980808: ASL-ADE

American Sign Language-Accessible Diabetes Education

Completed NA Results posted Last updated 10 July 2023

What this trial tests

NA trial testing American Sign Language-Accessible Diabetes Education in Diabetes in 41 participants. Completed in 26 January 2021.

Timeline

29 October 2020

Primary endpoint
26 January 2021

26 January 2021

Quick facts

Lead sponsor	Georgia Institute of Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	other
Enrollment	41
Start date	29 October 2020
Primary completion	26 January 2021
Estimated completion	26 January 2021
Sites	2 locations across United States

Drugs / interventions tested

• American Sign Language-Accessible Diabetes Education
• Control Intervention — full drug profile →

Conditions studied

• Diabetes — all drugs for Diabetes →
• Deafness — all drugs for Deafness →

Sponsor

Georgia Institute of Technology

Who can join

Adults 18 to 89, any sex, with Diabetes or Deafness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diabetes Health Literacy Score Primary · 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.

Group	Value	95% CI
ASL-ADE Intervention Arm	1.30	-.05 – 2.65
Control Arm	1.38	-1.15 – 3.90

Frequency of Engagement in Diabetes-Related Health Behaviors Primary · 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"

Group	Value	95% CI
ASL-ADE Intervention Arm	.2381	-1.1343 – 2.6205
Control Arm	2.0625	0.2532 – 3.8718

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for improving health literacy in migrants.
   Baumeister A, Aldin A, Chakraverty D, Hübner C, et al · · 2023 · cited 22× · PMID 37963101 · DOI 10.1002/14651858.cd013303.pub2