Clinical trial NCT05074173: Text My Hypertension BP Meds NOLA
Official title: Simple Text-Messaging and Social Support to Increase Hypertension Medication Adherence in New Orleans, Louisiana (LA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Quality of life
Adherence
High blood pressure
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: LA CaTS Clinical Research Resources Core
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-10-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.
3. Evaluate the role of social support in helping participants manage their hypertension and control of Cardiovascular disease (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.

Detailed description: 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, the information will be shredded. 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 Institutional Review Board (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 Atherosclerotic cardiovascular disease (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.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years of age.
* Speak and read English.
* Diagnosis of stage 1\* and 2\*\* hypertension (HTN), taking at least one antihypertensive medication.
* Internet and mobile phone access with two-way texting capability.
* \> 1 on 4-item Krousel-Wood Medication Adherence Scale (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)

Exclusion Criteria:

* Having been hospitalized within 6 months of starting the study if the patient has a diagnosis of heart failure, end-stage kidney disease, acute coronary syndrome, or stroke.
* Plans to cancel mobile phone plan within 3 months.

Primary outcomes:
measure: Measure of Quality of Life Assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life Questioner
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Change in Systolic and Diastolic Blood Pressure Done by Investigators
timeFrame: Baseline, 2 months
measure: Self-report Adherence to Medication
timeFrame: Baseline, 2 months
measure: Change in Systolic and Diastolic Blood Pressure Done by the Participant
timeFrame: First week of the study, Last week of the study
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Christian Unity Baptist Church
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Keith Ferdinand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferdinand KC, Senatore FF, Clayton-Jeter H, Cryer DR, Lewin JC, Nasser SA, Fiuzat M, Califf RM. Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications. J Am Coll Cardiol. 2017 Jan 31;69(4):437-451. doi: 10.1016/j.jacc.2016.11.034.
citation: Ferdinand DP, Nedunchezhian S, Ferdinand KC. Hypertension in African Americans: Advances in community outreach and public health approaches. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):40-45. doi: 10.1016/j.pcad.2019.12.005. Epub 2019 Dec 19.