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Behavioral Intervention
Mobile Health App for High Blood Pressure
N/A
Waitlist Available
Led By LaPrincess C Brewer, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-intervention
Awards & highlights
Study Summary
This trial will test whether a smartphone app can help African-American patients with uncontrolled hypertension manage their condition better.
Who is the study for?
This trial is for African-American adults with uncontrolled high blood pressure who are patients at certain health centers and plan to stay there for the next 6 months. They must own a smartphone compatible with the app. Those unable to attend focus groups or with conditions that hinder app use, like severe visual/hearing impairments, can't join.Check my eligibility
What is being tested?
The study is examining if a culturally-tailored mobile app can help African-Americans manage their hypertension better. Participants will receive health education and self-management tools through this smartphone application as part of their care routine.See study design
What are the potential side effects?
Since this intervention involves using an educational mobile app rather than medication, traditional side effects are not expected. However, participants may experience issues related to technology use such as eye strain or stress from learning new technology.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure (systolic and diastolic, mmHg)
Hypertensive disease
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Secondary outcome measures
Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management
Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores
Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)
+1 moreOther outcome measures
Intervention Feasibility Measures - Participant Engagement with Modules
Intervention Feasibility Measures - Participant Engagement with Sharing Board
Intervention Satisfaction Measures - Participant Satisfaction with FAITH! HTN App
Trial Design
1Treatment groups
Experimental Treatment
Group I: FAITH! App-enhanced Hypertension InterventionExperimental Treatment1 Intervention
FAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management.
Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,068 Total Patients Enrolled
LaPrincess C Brewer, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are of African American descent.Your blood pressure is too high and not being managed with medication.Your medical records show that you have high blood pressure.You have visited one of the two partnering health centers at least once in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: FAITH! App-enhanced Hypertension Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary aspirations of this medical experiment?
"This medical trial aims to ascertain the effect of its intervention on Blood Pressure (systolic and diastolic, mmHg) over a 6-month period. Secondary metrics include Self Efficacy for Medication Adherence as evaluated by the MASES scale (medication adherence self-efficacy scale), Social Determinants of Health (SDOH, PRAPARE tool), and Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management measured using a 5-item instrument."
Answered by AI
Is enrollment ongoing for this experimental procedure?
"Per the information on clinicaltrials.gov, this particular trial has halted its recruitment process. Initially posted on April 15th 2021 and last updated March 11 2022, this study is currently not accepting participants; however, 746 other trials are actively recruiting patients at present."
Answered by AI
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