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American Sign Language-Accessible Diabetes Education (ASL-ADE)

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ClinicalTrials.gov Identifier: NCT03980808
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Georgia Institute of Technology

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.

Condition or disease Intervention/treatment Phase
Diabetes Deafness Behavioral: American Sign Language-Accessible Diabetes Education Behavioral: Control Intervention Not Applicable

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 age and diagnosis status to measure if variance in scores are related to age, with a specific interest in transition aged (18-30) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

Solomon Four-Group Design will be used to distinguish intervention effects from pretest effects. There will be two intervention groups and two control groups as detailed below:

Intervention Group 1 will (a) take the pretest, (b) view the video intervention, (c) immediately following the intervention take the posttest, and (d) 30-days following take the posttest.

Control Group 1 will (a) take the pretest (b) view a non-health related video approximately the same length as the video intervention, and (c) take the posttest at the 30-day follow-up posttest.

Intervention Group 2 will (a) view the video intervention, (b) immediately following the intervention take the posttest, and (d) 30-days following take the posttest.

Group 2 will (a) take the posttest and (b) 30-days following, take the 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

Masking: Single (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.
Primary Purpose: Other
Official Title: American Sign Language-Accessible Diabetes Education
Estimated Study Start Date : December 13, 2019
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASL-ADE Intervention Arm
One-half of enrolled participants will view the ASL-ADE video intervention.
Behavioral: 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.
Other Name: ASL-ADE

Sham Comparator: Control Arm
One-half of enrolled participants will view a non-health related video approximately the same length as the video intervention.
Behavioral: Control Intervention
Non-health related video approximately the same length as ASL-ADE.




Primary Outcome Measures :
  1. Diabetes Health Literacy Score [ Time Frame: 3 months ]
    Data will be collected using study-specific questionnaires that measure diabetes knowledge. They will be forced choice, closed-ended questions to allow for a total score ranging from 0 correct to all correct.

  2. Frequency of Engagement in Diabetes-Related Health Behaviors [ Time Frame: 3 months ]
    Data will be collected using study-specific questionnaires that measure frequency of diabetes-related health behaviors (e.g., vegetable, whole grains, and fruit intake; dietary fat intake, alcohol intake, smoking, exercise, and regular healthcare maintenance such as having an annual physical).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980808


Contacts
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Contact: Muslimah "Salimah" S LaForce, M.S. 404-839-8741 salimah@cacp.gatech.edu
Contact: Maureen A Linden, M.S. BME 404-894-4804 maureen.linden@design.gatech.edu

Locations
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United States, Georgia
Center for Advanced Communications Policy Not yet recruiting
Atlanta, Georgia, United States, 30332
Contact: Mary Williams    404-894-8700    mary.williams@rbi.gatech.edu   
Principal Investigator: Muslimah "Salimah" S LaForce, M.S.         
Sub-Investigator: Maureen A Linden, M.S. BME         
United States, Texas
Deaf Link, Inc. Not yet recruiting
San Antonio, Texas, United States, 78232
Contact: Kay Chiodo    210-590-7446    kaychiodo@deaflink.com   
Sponsors and Collaborators
Georgia Institute of Technology
Investigators
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Principal Investigator: Muslimah "Salimah" S LaForce Georgia Institute of Technology

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Responsible Party: Georgia Institute of Technology
ClinicalTrials.gov Identifier: NCT03980808     History of Changes
Other Study ID Numbers: H19229
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgia Institute of Technology:
Diabetes
Deafness
Additional relevant MeSH terms:
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Diabetes Mellitus
Deafness
Hearing Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms