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Text My Hypertension BP Meds NOLA

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074173
Recruitment Status : Completed
First Posted : October 12, 2021
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
LA CaTS Clinical Research Resources Core
Information provided by (Responsible Party):
Tulane University

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Text Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Simple Text-Messaging and Social Support to Increase Hypertension Medication Adherence in New Orleans, Louisiana (LA)
Actual Study Start Date : March 10, 2022
Actual Primary Completion Date : May 28, 2022
Actual Study Completion Date : May 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patient Group
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 anti-hypertension 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 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.
Behavioral: Text
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.




Primary Outcome Measures :
  1. Quality of life assessed by 14-item Center for Disease Control (CDC) Health Related Quality of Life questioner [ Time Frame: Baseline, 2 months ]
    The change of quality of life will be measured by the responses from the 14-item Center for Disease Control (CDC) Health Related Quality of Life questioner at the enrollment (baseline) visit and at the end of study visit at 2 months. The questioner is a CDC designed quality of life survey that has 14 questions, and the investigators will calculate the unhealthy days score for each participant and sum the number of physically unhealthy and mentally unhealthy days, then subtract the unhealthy days from 30 to calculate a healthy days score.


Secondary Outcome Measures :
  1. Change in systolic and diastolic blood pressure [ Time Frame: 8 weeks ]
    Change in systolic and diastolic blood pressure will be measured in millimeters of mercury from day one of enrollment (baseline) and daily through the end of study visit. The study team will measure both the systolic and diastolic blood pressure at baseline visit and end of study visit, while the subject will be performing the self measured systolic and diastolic blood pressure readings at home everyday throughout the study.

  2. Self-report adherence to medication [ Time Frame: Baseline, 2 months ]
    Self-report adherence to medication will be measured based on qualitative analysis of the Krousel-Wood Medication Adherence Scale 4. The subject will complete the survey twice, at baseline visit and at the end of study visit. The score range is 0 to 4 with a higher score indicating worse adherence, and a lower score indicating better adherence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT05074173


Locations
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United States, Louisiana
Christian Unity Baptist Church
New Orleans, Louisiana, United States, 70112
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University
LA CaTS Clinical Research Resources Core
Investigators
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Principal Investigator: Keith Ferdinand, MD Tulane University School of Medicine
Publications:
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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT05074173    
Other Study ID Numbers: 2021-887
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tulane University:
Quality of life
Adherence
High blood pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases