American Sign Language-Accessible Diabetes Education

NCT03980808 | Completed Results

• 2 other identifiers: H192295P30DK111024-04
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes; Deafness

Keywords

Diabetes; Deafness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The outcome measure results for the Your Health Behaviors measure are a comparison between the pretest and the 30-day follow-up.

Study Arms (2)

ASL-ADE Intervention Arm

EXPERIMENTAL

One-half of enrolled participants will view the ASL-ADE video intervention.

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.

Behavioral: Control Intervention

Interventions

American Sign Language-Accessible Diabetes Education BEHAVIORAL

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.

Also known as: ASL-ADE

ASL-ADE Intervention Arm

Control Intervention BEHAVIORAL

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Deaf
• Primary language is American Sign Language
• Approximately one-half of the sample must have a diabetes diagnosis.

You may not qualify if:

• Minors
• People whose primary language is not ASL
• Individuals unable to provide consent due to impaired decision-making

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Center for Advanced Communications Policy

Atlanta, Georgia, 30332, United States

Location

Deaf Link, Inc.

San Antonio, Texas, 78232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Deafness

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Salimah LaForce, M.S.
• Organization: Georgia Institute of Technology

salimah@cacp.gatech.edu

404-385-4614

Study Officials

• Muslimah "Salimah" S LaForce

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: October 29, 2020
• Primary Completion: January 26, 2021
• Study Completion: January 26, 2021
• Last Updated: July 10, 2023
• Results First Posted: September 27, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available immediately following publication and with no end date.
• 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).

Locations

US (2)