American Sign Language-Accessible Diabetes Education
Phase: NA
Conditions: Diabetes, Deafness
Sponsor: Georgia Institute of Technology

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Official Title: American Sign Language-Accessible Diabetes Education 
 
NCT Number: NCT03980808  
 
Study Protocol: December 16, 2021 
 

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Study Protocol  
 
AMERICAN SIGN LANGUAGE-ACCESSIBLE DIABETES EDUCATION 
 
Principal Investigators 
 
Salimah LaForce, M.S. 
 
 
 
 
 
Research Scientist II 
Georgia Institute of Technology 
Atlanta, Georgia, United States 
 
Maureen Linden, M.S. BME 
Senior Research Engineer 
Georgia Institute of Technology 
Atlanta, Georgia, United States 
 
 
 
Protocol identification number 
H19229 
 
ClinicalTrials.gov identifier  
NCT03980808 
 
 
Authors 
 
 
 
Salimah LaForce, M.S. 
 
 
 
 
 
Research Scientist II 
Georgia Institute of Technology 
Atlanta, Georgia, United States 
Maureen Linden, M.S. BME 
Senior Research Engineer 
Georgia Institute of Technology 
Atlanta, Georgia, United States 
 
 
Version  
 
 
 
Draft 1 
 
 
 

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Study Protocol 
AMERICAN SIGN LANGUAGE-ACCESSIBLE DIABETES EDUCATION 
 
Study Protocol, drafted by the Principal Investigator (PI), Salimah LaForce, and Co-PI, Maureen 
Linden, hereinafter referred to as “we.” 
 
PURPOSE AND AIMS 
According to recently published data, 25% of the U.S. population is comprised of adults with 
disabilities, with approximately 6% of the sample having a hearing disability. Prevalence of 
hearing disabilities increases with age and poverty level.i These estimates are likely conservative 
due to (a) their limitation to non-institutionalized adults, (b) sampling method, and (c) their 
reliance on self-identification. People who are culturally Deaf view their deafness as a 
difference, and thus do not self-identify as having a disability. People who are culturally Deaf 
view themselves as a linguistic minority, bonded by their use of a common signed language, 
shared experiences, and shared values and norms (e.g., collectivism, rejection of the disability 
label, Deaf pride, solidarity, directness, expressiveness).ii Like other minority populations in the 
United States, people who are culturally Deaf are at risk for developing diabetes and acute 
complications related to unmanaged diabetes. Also, there is a diabetes subtype, maternally 
inherited diabetes and deafness (MIDD) that, although rare, accounts for a portion of diabetes 
cases in the deaf population.iii,iv Increased risk is associated with low rates of health literacy due 
to lack of accessible health informationv and isolation from the hearing world.vi,vii Further, 
because the language and communication barrier for the population is so pervasive, it is 
anticipated that standard transition of care materials may overestimate the diabetes knowledge of 
people who are Deaf and transitioning into independent care routines. As such, materials may 
need to be restructured to account for any knowledge deficits. This project will not only evaluate 
an educational intervention, but the research is designed in such a way as to measure if there are 
any between-group differences in knowledge about diabetes based on whether the subject has a 
diabetes diagnosis or not.    
 
Given the language barrier and insufficent provision of certfied sign lanagueg interpretes during 
medical vistis, we hypothesize that people who are Deaf without a diabetes diagnosis and those 
who are Deaf with a diabetes diagnosis will have similar levels of diabetes knowledge. 
 
The aim of this study is to evaluate an ASL-interpreted diabetes educational intervention to 
quantitatively demonstrate a need for diabetes educational outreach materials to be accessible to 
people who are Deaf and rely on ASL for clear and effective communications. 
 
SURVEY OF THE FIELD 
This project addresses disparate health outcomes related to health literacy levels of people who 
are Deaf.  The Agency for Healthcare Research and Quality (AHRQ) within the U.S. Department 
of Health and Human Services, notes that low health literacy among all adults in the United 
States results in adverse healthcare outcomes.viii  Individuals who are Deaf and hard of hearing 
have been shown to have lower health literacy levels compared to their hearing counterparts with 

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the same level of formal education.ix Dammeyer and Chapman (2017) also found corroborating 
evidence that people with hearing loss have an increased risk of developing a physical illness 
compared to the general population.x Consequently, the low levels of general health literacy 
among people who are Deaf increases risk for developing chronic illnesses,xi,xii,xiii including 
diabetes.xiv One comparative study found that subjects who were Deaf compared to those who 
were not had similar rates of diabetes diagnoses when blood sugar levels were tested. However, 
the subjects that were Deaf had lower levels of awareness about their blood sugar levels, often 
not self-reporting that they had diabetes when explicitly asked, resulting in poor self-
management of their condition.xv  
 
Quantifying the prevalence of diabetes among the target population is difficult due to the 
language barrier and broad health data surveys not consistently accommodating ASL. However, 
there is evidence that people who are Deaf have a high prevalence of health-related risk factors 
associated with diabetes. Dair, Ellis, and Lieberman (2006) using body mass index (BMI) 
national averages for the age group as the comparison found that 23.2% of their sample of 
children (6-11 years old) who were Deaf were overweight, and 27.2% were at risk for becoming 
overweight.
xviii
xvi According to the authors, these findings are significant given that being 
overweight as a child is correlated to adulthood obesity, which in turn is associated with diabetes 
and other illnesses (e.g., hypertension). Also, there is a diabetes subtype, maternally inherited 
diabetes and deafness (MIDD) that, although rare, accounts for a portion of diabetes cases in the 
deaf population.xvii,
 
 
Barnett et al. (2016; 2017) developed a standardized, computer-based, linguistically adapted 
public health survey. They asserted that health data from the culturally Deaf are not included in 
public health surveillance due to the survey instruments not being available in ASL. As such, the 
specific public health needs of this population are unknown.xix This lack of data was posited as a 
contributing factor to disparate health outcomes because the results of health surveillance studies 
are used to develop population-specific health outreach, resources, and services. The results of 
the adapted tool indicated that the sample of Deaf respondents reported higher rates of 
emergency department use than the general population (16% compared to 6.9% visiting an 
emergency room twice in one year), as well as a higher propensity to forego utilizing health 
services due to the costs (22.7% compared to 8.1%).xx Extrapolations from these data support the 
notion that people who are Deaf may present with more acute symptoms and suffer greater 
health consequences as a result of the confluent factors of delays in treatment and limited health 
literacy. The research not only provided evidence of disparate health issues experienced by 
people who are culturally Deaf, but its findings suggest that health disparity outcomes are 
associated with language barriers, showing a critical need for ASL-adapted health education 
programs. 
 
As an example of the adverse health impacts of language and communication barriers in the 
medical context, one could look to research on medication adherence. Many people, for various 
reasons, struggle with managing their medications and lack of adherence to medication regimens 
is associated with poorer health outcomes, including 40% of nursing home admissions in people 

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with type 2 diabetes.
xxiii
xxi That statistic may be exponentially higher in the population of people 
who are Deaf. Ferguson and Liu (2015) conducted focus groups with 20 subjects who were Deaf 
or hard of hearing and found that these subjects struggled with the complexity of the written 
materials that were given to them as a means of communicating information about their 
medicines.xxii  In this study, five of the participants (25%) reported adverse events stemming from 
a lack of understanding of medication instructions or warnings. These included excessive 
drowsiness from taking too much medication, dizziness caused by taking two interacting 
medications together, and needing to pull-over while operating a vehicle under the influence of a 
prescribed narcotic.
 In another study, 40% of focus group participants who were Deaf were 
unaware that an adverse reaction could result from not taking their medications appropriately.xxiv  
Two-thirds (67%) of these respondents stated that they would better understand the information 
if provided in ASL.xxv In sum, while one of the greatest barriers faced by people who are 
culturally Deaf are communication-based,xxvi little has been done to ensure that health education 
and outreach materials are effectively communicated to the target population.  
 
PROJECT DESIGN 
 
Population: Individuals who are Deaf and who rely on ASL for clear and effective 
communication/comprehension are the primary target population for this research. Estimates of 
the size of this population range from 500,000 to 2 million,xxvii xxviii
xxxii
,
 but these estimates are 
hampered by problems with systemic data collection. Unfortunately, the United States does not 
document the number of individuals that use ASL as their primary language either through the 
Decennial Census, the American Community Survey (ACS) or through any government agency. 
These surveys are administered in written English text, which is not well understood by people 
who are Deaf and rely on ASL, for whom reading comprehension level has been estimated to be 
at the fourth-grade level.xxix,xxx,xxxi  Even if written English is understood by the respondent, the 
ACS and Decennial Census do not include ASL as an option in their questions regarding 
household language.
 Finally, the surveys reflect a hearing primacy evident in the emphasis on 
spoken language, making it difficult to answer What languages other than English are spoken in 
the household? if one’s native language is ASL.   
 
Screening and inclusion process: Study subjects (n=41) were recruited by project partners, 
Deaf Link, using ASL-interpreted video recruitment and staffers who are Deaf to communicate 
with prospective subjects via videophone. Twenty-one subjects were Deaf with a self-reported 
diabetes diagnosis and 20 subjects were Deaf without a diabetes diagnosis (self-reported). 
 
Inclusion criteria was the provision of informed consent, aged 18 years and older, Deaf whose 
primary language is ASL with or without a diabetes diagnosis.  
Exclusion criteria was minors, people whose primary language is not ASL, individuals unable to 
provide consent due to impaired decision-making. 
 
Intervention: The project produced a video-based ASL interpreted diabetes educational 
intervention (ASL-ADE). The content for the ASL-ADE intervention was derived from diabetes 

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health information regarding symptoms and risk factors that are published by the American 
Diabetes Association and subject matter experts Guillermo E. Umpierrez, MD, Professor of 
Medicine, Emory University School of Medicine, Division of Endocrinology, Metabolism and 
Chief of Diabetes and Endocrinology, Grady Health Systems; and Ina Flores, MS, RD, CDE, 
CDN, Assistant Program Director - Emory Latino Diabetes Education Program at Emory 
University School of Medicine. In collaboration with our subawardee, Deaf Link, Inc., the ASL-
ADE scripts were reviewed for content to ensure clarity and determination of ASL signs to be 
used to convey the meanings. This approach allowed for the collaborative inclusion of Deaf 
community stakeholder’s knowledge, perspectives, and experience related to ASL interpretation 
of health concepts. Certified ASL interpreters and representatives from the Deaf population met 
to determine the optimal ASL terms for the content. Based on their expertise, scripts were be 
refined and revised as necessary. The ASL-ADE video intervention was produced through a 
multi-step process that consisted of pre-production planning, video production, quality control, 
and post-production. The final intervention was a four-part video series: 
1. What is Type 2 Diabetes? 
https://youtu.be/Nmy84TqxMA8  
2. How to Check Your Blood Glucose 
https://youtu.be/QYJyzpzfeoE 
3. Understanding Hypoglycemia and Hyperglycemia 
https://youtu.be/wOOWr7Bzd4o 
4. Exercise and Nutrition Can Help Manage Diabetes 
https://youtu.be/wWB-xOabb9U 
 
Outcome: All visits were conducted individually though a virtual meeting platform and included 
a certified ASL interpreter who is bound by professional ethics codes regarding confidentiality.  
Recruitment and intervention were ongoing from October to December 2020 (rolling enrollment, 
~ 30day follow-up). Though the questionnaires are self-report, they were administered by the 
PI's and the participants' answers directly input into the online Qualtrics survey.  
 
Data was collected using study-specific ASL-interpreted questionnaires designed by project 
personnel. The questionnaire items that measure diabetes knowledge included in the ASL-ADE 
intervention were forced choice, closed-ended questions to allow for a total score ranging from 0 
correct to all correct. Covariates included self-reported information of interests to the study such 
as gender, age, educational level, level of pre-study exposure to diabetes-related health 
information, and health behaviors (e.g., diet, exercise, healthcare maintenance). The content of 
the post-test (immediate) and post-test 30-day follow-up were identical. The pretest contained 
demographics questions that we only asked once.  
 
Using a pretest-posttest (immediate), 30-day posttest quasi-experimental design, we tested the 
effect of the educational intervention on knowledge about diabetes and related health behavior 
changes. The dichotomous X variable was diagnosis status, and the outcome variable (Y) was test 
scores. Any observed group mean differences, or lack thereof, were anticipated to be predicted 
by membership in the group. The pre and posttest intervention questionnaires adapted, in part, 

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from the CDC's Behavioral Risk Factor Surveillance System (BRFSS) were administered as 
follows:  
 
Phase One: 
 
Step 1 - Pretests 
Section 1: Your Awareness of Diabetes 
Section 2: Your Health Behaviors 
Section 3: Diabetes Health Literacy 
Section 4: Demographics 
 
Step 2 - Research Participants in the intervention Group Views Videos  
 
Step 3 - Posttest Immediate 
Section 1: Diabetes Health Literacy 
Phase Two: 
Posttest ~30 Days Later 
Section 1: Diabetes Health Literacy 
Section 2: Your Health Behaviors 
Debriefing where correct answers are provided for the Diabetes Health Literacy 
questionnaire and the intervention offered to the control group. 
 
Data handling: The questionnaire based raw data will be electronically stored in the Qualtrics 
survey platform, using code linkage. A master data file, downloaded from Qualtrics, will be kept 
as a password protected Excel file to ensure access to unadulterated raw data. Georgia Tech's IT 
systems continuously monitor for adverse events.  
 
Archiving of data. Data is archived for at least 10 years. 
 
Ethical considerations: this study is conducted in compliance with the ethical principles and 
guidelines detailed by the National Commission for the Protection of Human Subjects of 
Biomedical and Behavioral Research in The Belmont Report, and applicable federal, state, and 
local laws in Atlanta, Georgia, United States, whichever affords the greater protection to the 
research subjects. The study procedures and documents were approved by the Georgia Institute 
of Technology’s Internal Review Board, protocol number H19229. A Certificate of 
Confidentiality was obtained from the National Institutes of Health to help keep subject 
information confidential. This Certificate provides a way that researchers cannot be forced to 
disclose identifying information, even by a court subpoena, in any federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. 
 
 
 
 

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ii Lane, H. (2005). Ethnicity, ethics, and the deaf-world. Journal of Deaf Studies and Deaf Education, 
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xi NASERIBOORIABADI, T., SADOUGHI, F., & SHEIKHTAHERI, A. (2017). Barriers and facilitators 
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xvi Dair, J., Ellis, M. K., & Lieberman, L. J. (2006). PREVALENCE OF OVERWEIGHT AMONG DEAF 
CHILDREN. American Annals of the Deaf, 151(3), 318-26. 
doi:http://dx.doi.org/10.1353/aad.2006.0034  
xvii Mazzaccara, C., Iafusco, D., Liguori, R., Ferrigno, M., Galderisi, A., Vitale, D., . . . Sacchetti, L. 
(2012). Mitochondrial diabetes in children: Seek and you will find it. PLoS One, 7(4) 
doi:http://dx.doi.org/10.1371/journal.pone.0034956  
xviii Wu, H., Hou, J., & Zhang, W. (2012). Case studies in nursing of mitochondrial diabetes. Pakistan 
Journal of Medical Sciences Quarterly, 28(3), 536-539. Retrieved from 
https://search.proquest.com/docview/1115593847?accountid=36783  
xix Barnett, S. L., Matthews, K. A., Sutter, E. J., DeWindt, L. A., Pransky, J. A., O’Hearn, A. M., Tamal, 
D. M., Pollard, R. Q., Samar, V.J., & Pearson, T. A. (2016; 2017). Collaboration with deaf 
communities to conduct accessible health surveillance. American Journal of Preventive Medicine, 
52(3), 250-254. doi:10.1016/j.amepre.2016.10.011 
xx Ibid, p. 253. 
xxi National Council on Patient Information and Education. Poor Medicine Adherence. Be Smart Medicine 
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xxii Ferguson, M. and M. Liu, Communication needs of patients with altered hearing ability: informing 
pharmacists’ patient care services through focus groups. Journal of the American Pharmacists 
Association, 2015. 55(2): p. 153-160. 
xxiii Ibid. 
xxiv Jacob, S.A., et al., The needs of the deaf and hard of hearing when seeking pharmaceutical care. 
Research in social & administrative pharmacy: RSAP, 2016. 12(4): p. 664-665. 
xxv Ibid. 
xxvi Mitchell, R. E., Young, T. A., & Bachleda, B. (2006). How many people use ASL in the United 
States? Why estimates need updating. Sign Language Studies, 6(3), 306-335. 
doi:10.1353/sls.2006.0019 
xxvii Bennett, D., LaForce, S., Touzet, C., & Chiodo, K. (2018). American Sign Language & Emergency 
Alerts: The Relationship between Language, Disability, and Accessible Emergency Messaging. 
International Journal of Mass Emergencies and Disasters, 36(1), 71-87. 
xxviii McKee, M. M., Winters, P. C., Sen, A., Zazove, P., & Fiscella, K. (2015). Emergency Department 
utilization among Deaf American Sign Language users. Disability and health journal, 8(4), 573-
8. 
xxix Ebert, D.A. and P.S. Heckerling, Communication with deaf patients: knowledge, beliefs, and practices 
of physicians. Jama, 1995. 273(3): p. 227-229. 
xxx Scheier, D.B., Barriers to health care for people with hearing loss: a review of the literature. Journal of 
the New York State Nurses Association, 2009. 40(1): p. 4. 
xxxi Witte, T.N. and A.J. Kuzel, Elderly deaf patients' health care experiences. The Journal of the 
American Board of Family Practice, 2000. 13(1): p. 17-22. 
xxxii Mitchell, R. E., Young, T. A., & Bachleda, B. (2006). How many people use ASL in the United 
States? Why estimates need updating. Sign Language Studies, 6(3), 306-335. 
doi:10.1353/sls.2006.0019