Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting
Conditions: Pregnant, Postpartum
Sponsor: Washington University School of Medicine

 
 
 
Feasibility of Remote Data Collection With a Point of 
Care Device to Measure HbA1c 
 
 
 
Protocol  
 
 
 
 
 
 
May 16, 2025 
 
NCT05725746 
 
 
 

 
 
 
 
Primary Aim 
• 
What is the acceptability and feasibility of virtual instruction for home data collection using 
an A1c point of care device? 
 
Design and Methods 
• 
Observational Study 
• 
Parents enrolled in a home visiting program (at least 18 years of age; English or Spanish 
speaking) were contacted by the research team.  Those that consented were sent AIc point of 
care device.  Research staff completed a virtual meeting with participants to use the A1c 
device.  Participants completed a short survey that included questions regarding their 
satisfaction with using the device. 
 
Statistical Analysis Plan 
 
Descriptive statistics were only applied to assess feasibility and accessibility.  
 
Background and Significance 
Diabetes and cardiometabolic disease are increasing in people of childbearing age at alarming 
proportions. There is a critical need to develop and test effective strategies to mitigate these 
diseases. However, barriers to in-person data collection limit opportunities for participation in 
research that tests lifestyle interventions, particularly for parents due to barriers such as time and 
transportation. With the recent widespread use of virtual technology (e.g., live 
videoconferencing) there is an opportunity to conduct research assessments virtually, potentially 
mitigating time and transportation constraints to participation. 
 
References 
Plüddemann A, Thompson M, Price CP, Wolstenholme J, Heneghan C. Point-of-care testing for 
the analysis of lipid panels: primary care diagnostic technology update. Br J Gen Pract. 2012 
Mar;62(596):e224-6. doi: 10.3399/bjgp12X630241. PMID: 22429442; PMCID: PMC3289831. 
 
Sohn AJ, Hickner JM, Alem F. Use of Point-of-Care Tests (POCTs) by US Primary Care 
Physicians. J Am Board Fam Med. 2016 May-Jun;29(3):371-6. doi: 
10.3122/jabfm.2016.03.150249. PMID: 27170794. 
 
Lilly CM, Ensom E, Teebagy S, DiMezza D, Dunlap D, Hafer N, Buchholz B, McManus D. 
Patient Preferences for Point-of-Care Testing: Survey Validation and Results. Point Care. 2020 
Dec;19(4):112-115. doi: 10.1097/poc.0000000000000214. PMID: 34707464; PMCID: 
PMC8547737. 
 
 
 
 
 
 

 
 
 
 
 
 
CONSENT INFORMATION SHEET 
 
We invite you to participate in a research study being conducted by investigators from 
Washington University in St. Louis.  
 
You are being asked to participate in this research study because you are participating 
in the Parents as Teachers program. The purpose of this study is to evaluate data 
collection procedures for a project called ENRICH.  
 
If you agree, you will be volunteering to participate in the research study. As a voluntary 
participant, you will be asked to meet with someone virtually to obtain your AIC (a 
measure of your average glucose level over the past three months) through device 
placed on your upper arm for 5 minutes to collect a blood sample. The equipment you 
need will be mailed to you. The research team will obtain the measurement via video 
call.  If you are unable to do a video call, the research team will instruct you over the 
phone.  
 
You will also need to complete a phone survey that takes about 5 minutes. The survey 
will ask questions about your overall opinion of the data collection process, as well as 
demographic information and health related to diabetes and heart disease.  
 
If you agree to text messaging later in this consent document, you will receive a 
maximum of 2 text messages unless you want to use text to schedule and/or reschedule 
data collection visits in which you may receive a few more text messages. 
 
The National Institutes of Health is funding this research study.   
 
Video Recording  
One aspect of this study involves making video recordings of you.  The video recordings 
will be used to help us improve on the data collection process.  Only members of the 
research team will be able to review the audio recordings and they will be destroyed 
once the study is complete.  
 
While all recordings are stored in a confidential manner, please be aware that it may be 
possible to identify you from your recording. 
 
I give you permission to make video recordings of me during this study.  
 
_____ Yes          _____ No  (Record response) 
 
 
The data we are obtaining in this study may be made available for studies going on right 
now as well as studies that are conducted in the future. These studies may be done by 
researchers at Washington University, other research centers and institutions, or private 
companies involved in research.   
 

 
 
 
 
 
 
 
We may also share your research data with large data repositories (a repository is a 
database of information) for use by others, such as the research community, institutions, 
private companies and the general public. If your individual research data is placed in 
one of these repositories, your name and other identifying information will be removed.  
All reasonable precautions will be taken to protect your privacy and confidentiality.  
Necessary approvals will be obtained to use the data. Certain summary information may 
be available to the general public.  
 
If you change your mind and do not want us to store and use your data for future 
research, you should contact the research team member identified at the top of this 
document.  The data will no longer be used for research purposes. However, if some 
research with your data has already been completed, the information from that research 
may still be used. Also, if the data has been shared with other researchers it might not 
be possible to withdraw the data to the extent it has been shared. 
 
Approximately 15 people will take part in this study at Washington University. 
 
The main risks to you if you participate are discomfort when obtaining your AIC.  There 
is a slight risk of infection, bruising and bleeding at the site. You are free to skip any 
questions that you prefer not to answer. You may choose to stop participating and 
withdraw from the study at any time.  
 
You will not not benefit from participating in this study. However, we hope that 
others may benefit in the future from what we learn as a result of this study.  
 
You will not have any costs for being in this research study.  
 
You will be paid for being in this research study. You will be given a $30 gift card 
after you complete the data collection visit. You will be asked to provide your 
social security number (SSN) in order for us to pay you. 
 
We will keep the information you provide confidential by labeling your data with a unique 
ID that can be linked to you. The research team will enter your data online using a 
unique ID. The record that links these IDs to your information will be encrypted and 
stored on a secure server. Data will be stored in an encrypted format on a secure server. 
Any hard copy information will be kept in a locked cabinet in a locked office.  
 
Any report or article that we write will not include information that can directly identify 
you.  The journals that publish these reports or articles require that we share your 
information that was collected for this study with others to make sure the results of this 
study are correct and help develop new ideas for research. Your information will be 
shared in a way that cannot directly identify you. 
 
Federal regulatory agencies and Washington University, including the Washington 
University Institutional Review Board (a committee that reviews and approves research 
studies) and the Human Research Protection Office may inspect and copy records  

 
 
 
 
 
 
pertaining to this research.  If we write a report about this study we will do so in such a 
way that you cannot be identified. 
 
To further protect your privacy, this research is covered by a Certificate of Confidentiality 
from the federal government. This means that the researchers can refuse to disclose 
information that may identify you in any legal or court proceeding or to anyone who is not 
connected with the research except if:  
• 
there is a law that requires disclosure, such as to report child abuse and neglect, 
or harm to self or others;  
• 
you give permission to disclose your information, including as described in this 
consent form; or 
• 
it is used for other scientific research allowed by federal law. 
 
You have the right to share your information or involvement in this study with anyone at 
any time. You may also give the research team permission to disclose your information 
to a third party or any other person not connected with the research.  
 
We would like to contact you by text message for the purposes listed below. Some of 
these messages may contain information that identifies you. 
• 
If needed we may ask you to send us a picture from your data collection visits. 
Also, if needed, we may text to schedule the data collection visit.  
 
Only the research team will have access to your texting communications. We will only 
communicate by text to send you the information listed above. If you have any questions 
or need to contact us for an urgent or emergent situation, please contact the research 
team member identified at the top of this document. Message and Data rates may apply.  
 
You should be aware that there are risks associated with allowing us to text you for the 
purposes of this study. 
• Text messaging is not a secure communication method.  
• 
There is always a risk that the text message could be intercepted or sent to the 
wrong telephone number. To avoid sending messages to the wrong number, the 
first text we send you will be a test message to ensure we have the correct 
telephone number. 
• Your employer will have access to any messages sent or received on any 
electronic devices used for work or through a work server. 
• 
If you lose your phone, others may be able to access the messages that we 
send. 
 
Do you agree to allow us to send you text messages as described above? 
 
_____ Yes          _____ No  (Record response) 
 
 
Your participation in this study is completely voluntary.  You may choose not to take part 
at all.  If you decide to participate in the study you may stop participating at any time.  

 
 
 
 
 
 
 
Any data that was collected as part of this study will remain as part of the study records 
and cannot be removed.  If you decide not to take part in the study or if you stop 
participating at any time, you won’t be penalized or lose any benefits for which you 
otherwise qualify.   
 
If you do not wish to participate in this study or want to end your participation in the 
study, you can stop taking the survey or not obtain the measurement. You will not be 
penalized or lose any benefits for which you otherwise qualify.  You can continue to 
participate in PAT. 
 
If you do not wish to participate in this study, you may tell the study team or parent 
educator that you are not interested. 
 
We encourage you to ask questions.  If you have any questions about the research 
study itself, please contact: Cindy Schwarz, 314-935-3063. If you feel you have been 
harmed from being in the study, please contact: Dr. Rachel Tabak, 314-935-0153. If you 
have questions, concerns, or complaints about your rights as a research participant, 
please contact the Human Research Protection Office at 1-(800)-438-0445 or email 
hrpo@wustl.edu.   General information about being a research participant can be found 
on the Human Research Protection Office web site, http://hrpo.wustl.edu.  To offer input 
about your experiences as a research participant or to speak to someone other than the 
research staff, call the Human Research Protection Office at the number above. 
 
Thank you very much for your consideration of this research study.