Simple Text-Messaging and Social Support to Increase Hypertension Medication Adherence in New Orleans, Louisiana (LA)
Phase: NA
Conditions: Hypertension
Sponsor: Tulane University

 
 
 
 
 
 
 
Study Title:  
Simple Text-Messaging and Social Support to 
Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS 
NOLA)  
 
 
 
NCT Number:  
NCT05074173 
 
 
Protocol Date:  
 
07/16/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title:  Simple Text-Messaging and Social Support to Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS NOLA)  
 
Version Date: 07/16/21 
Version Number: 2 
 
 
1. Study aim, Background, and Design  
 
Non- adherence to blood pressure medication can significantly predict substandard 
hypertension (HTN) management and cardiovascular (CVD) control.1  There are several main 
identified barriers that contribute to poor hypertension management in AA: low socioeconomic 
status, dysfunctional health care systems, the presence of comorbid medical conditions, 
complicated medication regimens, and certain personal patient characteristic.2 One particular 
social determinant, the support system of a patient, has been shown to positively contribute to 
patient adherence to pharmacotherapy.3,4,5 Telehealth and the utilization of technology have 
emerged and offered cost-effective health services through various platforms during the 
pandemic6,7; however, despite these benefits, telehealth strategies may not effectively 
coordinate care for patients with low socioeconomic status and residence in communities with 
limited access. It is necessary to determine the adequacy of health education learning and 
assessment for these patients.8 
 
The specific aims of this research study are to 1) engage participants with poorly controlled 
hypertension and medication non-adherence to use simple digital approaches, specifically 
recurring text-messages to improve medication adherence, 2) promote participant medication 
adherence and interaction with telehealth platforms with recurring text reminders on medication 
schedules and refills, science-based hypertension education content, and communication 
exchange with their health providers to improve blood pressure, and 3) evaluate the role of 
social support in helping participants manage their hypertension and control of CVD risk factors, 
including daily blood pressure measurement, changes in participant quality of life, and barriers 
towards medication adherence, and setting goals for health behaviors.   
 
2. Subject Population 
 
50 adult patients with hypertension will be recruited from the Tulane cardiology clinic and Christian 
Unity Baptist Church. All participants will need to satisfy the following inclusion criteria to enroll 
into the study: 
• 
Adults > 18 years of age. 
• 
Speak and read English. 
• 
Diagnosis of stage 1* and 2** HTN, taking at least one antihypertensive medication. 
• 
Internet and mobile phone access with two-way texting capability. 
• 
> 1 on K-Wood-MAS-4 or similar tool.   
• 
Able to download blood pressure tracking App to mobile phone. 
(*Stage 1 HTN: 130-139 mmHg or 80-89 mmHg16)  
(**Stage 2 HTN: 140 mmHg or higher or >90 mmHg16)  
 
The following exclusion criteria will prevent participants from enrolling in the study: 
• 
Having been hospitalized within 6 months of starting the study if you have a diagnosis of 
heart failure, end-stage kidney disease, acute coronary syndrome, or stroke.  
• 
Plans to cancel mobile phone plan within 3 months. 
 
Participants will be recruited by the academic and community principal investigators and key 
study personnel. Potential participants from the cardiology clinic will be identified by the study 
personnel and medical staff prior to cardiology appointment using their clinical knowledge and 
expertise and the patients’ medical history and records; the study team and medical staff will 
give potential participants the recruitment flyer if they are interested in the study. Interested 

Study Title:  Simple Text-Messaging and Social Support to Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS NOLA)  
 
Version Date: 07/16/21 
Version Number: 2 
 
 
patients seen in clinic will be asked to contact the IRB-approved study personnel directly. The 
research team will screen church participants following their regular Sunday service and 
distribute recruitment flyers to potential participants.  A recruitment script will be read by all 
study personnel when contacting potential participants by telephone. Eligible participants 
interested in participating in the study will make appointments with the study team to enroll at 
the Tulane cardiology clinic. 
3. Procedure  
All eligible participants will be enrolled into the study at the Tulane cardiology clinic for an 8-
week period. Key study personnel will screen patients from the clinic interested in the study 
during their appointment visit. Identifying information that will be collected from participants will 
be name, date of birth, and telephone number to send them text messages. Potential 
participants making study inquiries by email will receive prompt responses.  If the participant 
does not enroll in the study because they are not eligible, we will shred the information. Study 
personnel will also review medical records of Dr. Keith Ferdinand to identify potential patients 
and provide the subjects with study information (e.g. flyers, advertisements, recruitment script, 
etc.)  The subjects may then approach the study team about participation. Study personnel will 
arrange a time and date with the church community site to distribute flyers describing the study 
to church congregants to seek study interest. Interested persons can be screened on-site for 
eligibility or at a date to be determined by congregants. Study personnel will use an eligibility 
checklist to screen participants. Below are procedures performed during the study and the time 
expected to complete each task: 
This study will follow an 8-week interventional cohort design using a series of questionnaires to 
collect data pre-post study procedures from two sites: Tulane cardiology clinic and Christian Unity 
Baptist Church. Participants will be screened for eligibility at both sites by in-person interviews, 
telephone using an IRB-approved recruitment script, and/or clinic medical records. After 
screening, eligible participants will be enrolled into the study at Tulane cardiology clinic by study 
personnel. Blood pressure and weight will be measured by study personnel on the first and the 
last day of the study, in addition to calculating their risk for heart attack and stroke using the 
ASCVD Risk Estimator Plus.9 Study personnel will calculate participant’s ASCVD risk by 
downloading the app on their mobile device. No patient information is collected and stored in the 
app. Anonymous user behavior (e.g., number of people who downloaded the app, how many 
times a day the app was used) will be gathered through Google Analytics. All data collected in 
the app is anonymous and cannot be traced back to an individual user. 
 
Age, gender, race, medication, smoking behavior, and laboratory information from the clinic 
medical record will be inserted into the app to calculate ASCVD risk.  Calculations from the church 
site will be performed if participants have their laboratory values (e.x. total cholesterol, HDH 
cholesterol, and LDL cholesterol) to insert into the app. ASCVD risk will not be measured if 
participants do not have their laboratory values.  
 
Participants will be enrolled in a bidirectional text messaging system from Tulane University 
Medical Group where they will receive and send text from their mobile phones to monitor their 
antihypertension medication regimen. Text messages will be sent: daily for medication and refill 
reminders; weekly for hypertension education messages and asking if a support person helped 
them with medication reminders.  Study personnel will educate participants on proper blood 

Study Title:  Simple Text-Messaging and Social Support to Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS NOLA)  
 
Version Date: 07/16/21 
Version Number: 2 
 
 
pressure technique to conduct self-measured blood pressure (SMBP) at home. These blood 
pressure values will be automatically uploaded twice daily from a Bluetooth device to a phone 
application to allow the participant and healthcare team track their blood pressure. Participants 
will receive the Bluetooth blood pressure device to perform SMBP at enrollment. 
 
Participants will schedule their second and final in person appointment at the end of the 8-week 
period. Participants will be asked to complete the HRQOL-14 and K-Wood-Mas-4 adherence to 
medication scale, as well as have their blood pressure and weight measured.  
 
After the study team has coded the data, a statistician from Tulane University School of Public 
Heath will analyze and clean data for missing values using standard statistical software.  
Descriptive statistics will be measured for all variables to evaluate the range, mean, standard 
deviations, frequencies, variance and normality of the data.  Pearson correlational statistic will 
determine the association or relationship between hypertension medication adherence and text 
messaging, BP, and calculated ASCVD (atherosclerotic cardiovascular disease) Estimated 10-
year and Lifetime Risk and social support. 
 
 
Screening procedures: 
1. > 1 on K-Wood-MAS-4 adherence to medication scale 
2. Diagnosis of Stage 1 and Stage 2 hypertension (see above #2 Subject Population) 
3. Taking at least one antihypertensive medication. 
 
First day for enrollment procedures at the Tulane cardiology clinic: 
1. Sign informed consent 
2. Completion of questionnaires (demographic/medical history; HRQOL-14) 
3. Blood pressure and weight measurements 
4. Instructions on home blood pressure measurement with Bluetooth blood pressure 
device and download of Sphygmo app on participant mobile phone 
5. Instruction on receiving and responding to text messages on mobile phone  
 
Last day of study procedures at the Tulane cardiology clinic: 
1. Completion of HRQOL-14 and K-Wood-Mas-4 adherence to medication scale 
2. Blood pressure and weight measurements 
 
Study Procedures 
Time to Complete 
Sign informed consent 
10 minutes 
> 1 on K-Wood-MAS-4 adherence to 
medication scale 
2 minutes 
 Demographic and medical history form   
3 minutes 
HRQOL-14        
5 minutes 
Blood pressure education using Bluetooth 
blood pressure device to learn how to: 
Take proper self-measurement technique 
every day in the morning and evening 
Download Sphygmo app to monitor blood 
pressure 
10 minutes 
Instruction on receiving and responding to 
text messages on mobile phone 
10 minutes 

Study Title:  Simple Text-Messaging and Social Support to Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS NOLA)  
 
Version Date: 07/16/21 
Version Number: 2 
 
 
Measure clinic blood pressure and weight 
5 minutes 
Participants enrolled into the study will be identified by site (TCC for the cardiology clinic and 
CUBC for the church) and number beginning with 01 for each site. Participants will receive their 
standard medication regimen for the management of their hypertension from their primary 
provider. 
4. Risks 
Participation in this study involves minimal risk exposure.  Participants may experience 
inconvenience in taking time to complete the questionnaires and forms. The blood pressure cuff 
may feel uncomfortable after inflation while taking self-measurements.  Participants may feel the 
number of text messages received to be overwhelming. Although participants will have the option 
to opt-out of receiving text messages it will involve discontinuing the study.  There is the potential 
for loss of confidentiality by participating in the study. However, appropriate efforts will be made 
to protect the confidentiality of identifiable information.  All data will be stored and scanned on an 
external hard drive and in a locked file cabinet in Dr. Keith C. Ferdinand’s office accessible only 
by co-investigators for the duration of the study.  All identifiers will be removed and the data will 
be kept for a number of years in a safe place, or archived in the safe place. 
 
Standards of identifying, organizing, and assignment of data will be determined by investigators.  
Participants will be identified by assigned successive numbers beginning with 01 on study 
documents and by site, clinic or church.  All study documents will be organized in a file folder per 
participant.  The texting messaging system operated by The Tulane Medical Group will store 
messages on a HIPPA compliant secured cloud server.  The Sphygmo remote blood pressure 
monitoring system also uses HIPAA compliant data security procedures throughout the clinical 
workflow process from data collection to a cloud server storage center.  Data collected from the 
Tulane Medical Group text messaging system and Sphygmo will be identified by participant 
number and site.  This data will be organized in a report format by assigned identifying numbers 
and site. 
 
5. Benefits 
 
There will be no direct benefits to subjects for participating in this research, but the knowledge 
gained from the study may benefit society in general.  Anticipated benefits might include a 
participant’s greater understanding of different methods to increase adherence with 
hypertension medication to improve blood pressure. Participants will have use of a Bluetooth 
blood pressure device during the study, which will be significantly discounted for purchase if 
desired upon study completion. 
 
6. Remuneration 
 
Participants will receive a $20 gift card on the enrollment day, which is the first study visit, and a 
$30 gift card on the last study visit for travel to Tulane cardiology clinic and/or inconvenience.  
They will receive the compensation even if they did not complete study procedures. 
 
7. Academic or Extra Credit 
 
NA 

Study Title:  Simple Text-Messaging and Social Support to Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS NOLA)  
 
Version Date: 07/16/21 
Version Number: 2 
 
 
 
8. Costs 
 
There will be no costs for participating in this research study. 
 
9. Alternatives 
 
You do not have to participate in the research study.  
 
10. Consent Process and Documentation 
 
Approval of the study will be obtained from Tulane University IRB.  Following official IRB 
approval, the participants will be recruited and given a full description of the research purpose, 
personnel, procedures, risks, and benefits of the study.  They will be told that their participation 
is voluntary and have the right to discontinue at any time.  They will be asked to read the 
informed consent where the research team will answer any questions regarding the study.  If 
participants agree to participate in the study, they will be asked to sign the informed consent.  
The research team will keep these consents for at least 3 years.  
 
11. Qualifications of the Investigators 
 
Keith C Ferdinand, MD is academic co-investigator, clinical cardiologist, and professor of 
medicine at Tulane University School of Medicine. He has a clinical investigator and board 
certified in internal medicine and cardiovascular disease. His research is primarily focused on 
cardiometabolic risk and control, exploring differences across sex groups and racial/ethnic 
minorities in addition to the role of adherence in supporting better outcomes. Over the course of 
his career, he published 200 peer-reviewed articles, reviews, and book chapters and served on 
5 advisory boards, 2 of which I chaired. His clinical, administrative, and research experience 
supports his role as co-investigator for the proposed study.  
 
Daphne Ferdinand, PhD, RN is community co-investigator/project director, registered nurse, and 
executive director of the Healthy Heart Community Prevention Project. She has 22 years of 
experience in administration and management at Heartbeats Life Center, formerly a 
cardiovascular diagnostic testing center and clinical cardiology consultation practice. She was a 
clinical trials coordinator over hypertension and cholesterol research studies.  She developed and 
implemented a BP education and training program for neighborhood hair salons and 
barbershops; CVD prevention Sunday for church pastors. She co-authored publications on 
hypertension prevention and management, cardiometabolic risk, and community-based 
approaches to cardiovascular disease.  She is well qualified as a co-investigator and project 
director given her work and experience with community health programs. 
 
12. Statistical Analysis 
Age is summarized with means and standard deviations. All categorical participant 
characteristics are summarized with counts and percentages. Baseline, follow-up and 
differences in outcome variables are summarized with means and standard deviations. In 
addition, differences in outcome variables from baseline to follow-up are summarized with 
medians and interquartile range. Statistically significant differences from baseline to follow up 
were assessed using the Wilcoxon Signed Rank Test at the 5% significance level. P-values are 
reported for each comparison. Statistical analyses were performed using SAS9.4.   
 

Study Title:  Simple Text-Messaging and Social Support to Increase Hypertension Medication  
Adherence in New Orleans, LA (TEXT MY MEDS NOLA)  
 
Version Date: 07/16/21 
Version Number: 2 
 
 
 
12. References 
 
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doi:10.1093/jamia/ocaa067.  
2. Dagher L, Shi H, Zhao Y, Marrouche NF. Wearables in cardiology: Here to stay. Heart 
Rhythm. 2020;17(5):889-895. doi:10.1016/j.hrthm.2020.02.023.   
3. Cutler DM, Everett W. Thinking Outside the Pillbox — Medication Adherence as a Priority 
for Health Care Reform. New England Journal of Medicine. 2010;362(17):1553-1555. 
doi:10.1056/nejmp1002305.   
4. Krueger KP, Berger BA, Felkey B. Medication adherence and persistence: A 
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doi:10.1007/bf02850081.   
5. Mayberry LS, Osborn CY. Family Support, Medication Adherence, and Glycemic Control 
Among Adults With Type 2 Diabetes. Diabetes Care. 2012;35(6):1239-1245. 
doi:10.2337/dc11-2103.   
6. Ferdinand KC, Senatore FF, Clayton-Jeter H, et al. Improving Medication Adherence in 
Cardiometabolic Disease: Practical and Regulatory Implications. J Am Coll Cardiol. 
2017;69(4):437-451. doi:10.1016/j.jacc.2016.11.034  
7. Ferdinand DP, Nedunchezhian S, Ferdinand KC. Hypertension in African Americans: 
Advances in community outreach and public health approaches. Prog Cardiovasc Dis. 
2020;63(1):40-45. doi:10.1016/j.pcad.2019.12.005  
8. Aggarwal B, Liao M, Mosca L. Medication Adherence Is Associated with Having a 
Caregiver Among Cardiac Patients. Annals of Behavioral Medicine. 2013;46(2):237-242. 
doi:10.1007/s12160-013-9492-8 
9. Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC Jr, Sperling LS, Virani SS, Blumenthal 
RS. Use of risk assessment tools to guide decision-making in the primary prevention of 
atherosclerotic cardiovascular disease: a special report from the American Heart 
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DOI:10.1016/j.jacc.2018.11.005