American Sign Language-Accessible Diabetes Education (ASL-ADE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03980808|
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Deafness||Behavioral: American Sign Language-Accessible Diabetes Education Behavioral: Control Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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 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.|
|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|
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.
- 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.
- 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).
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
|Contact: Muslimah "Salimah" S LaForce, M.S.||firstname.lastname@example.org|
|Contact: Maureen A Linden, M.S. BMEemail@example.com|
|United States, Georgia|
|Center for Advanced Communications Policy||Not yet recruiting|
|Atlanta, Georgia, United States, 30332|
|Contact: Mary Williams 404-894-8700 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Muslimah "Salimah" S LaForce||Georgia Institute of Technology|