Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Ashton Krogman
CONTACT
LaPrincess Brewer, M.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Lainey Moen
CONTACT
NCT Number: NCT06346886
The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Ashton Krogman
CONTACT
LaPrincess Brewer, M.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Lainey Moen
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will remain in the intervention for 11 weeks. The app-based intervention is a tailored program to promote HTN self-management and knowledge through an 11-module educational video series with a focus on HTN. Participants will also be provided with at home Blood Pressure (BP) monitoring system to allow for self-tracking of BP measurements(automatically synchronized with the app). The app will include pre-post module quizzes, a tracking component for participants to input self-monitored measures (medication adherence, diet, physical activity, etc.). The app sharing board will be a moderated discussion platform and feed for participant interaction by posting healthy lifestyle practices through text, photographs and video to foster discussion on HTN management barriers/facilitators. The project team will post weekly to the sharing board on HTN-related topics to generate discussion among patients.
Time frame: Baseline, immediate post intervention
Systolic BP (mmHg) will be measured as an average of 3 sitting readings with an oscillometric automated device during in-clinic health assessments.
Time frame: Baseline, immediate, 3 months, 6 months post intervention
The H-SCALE is a 31-item instrument that assesses 6 HTN behavioral self-care activities recommended for optimal HTN management (BP medication adherence, weight loss/ideal body weight maintenance, adoption of a low-salt diet, regular physical activity for ≥30 minutes/day, limiting alcohol intake, and ceasing tobacco use).
Time frame: Immediate, 3 months, 6 months post intervention
Proportion of subjects reaching BP control (defined as meeting target BP of <140/90 mmHg)
Time frame: Baseline, immediate post intervention
BP (mmHg) will be measured 3 times per week during the 11-week intervention period using a home BP monitoring system. The 3 weekly measurements will be averaged and average weekly BP will be compared from baseline to immediate post intervention to determine the change in BP. This outcome is only evaluated in the intervention group as the control group will not undergo home BP cuff measurements.
Time frame: Immediate post intervention
Change in percentage correct scores (pre- and post- self-assessments) for each education module by patient and as a conglomerate (mean) for all patients.
Time frame: Baseline, immediate post intervention
HTN Knowledge will be assessed using a previously validated 11-item questionnaire which asks participants questions about the definition, prevention, management and complications of hypertension. Responses are record as true, false or uncertain to each question with true response receiving a score of 1 and false or uncertain responses receiving a score of 0. Total scores on the questionnaire range from 0-11 with higher scores reflecting better HTN knowledge.
Contact information is provided by the study sponsor or research team.
Ashton Krogman
CONTACT
Lainey Moen
CONTACT
Mayo Clinic
Other
FAITH! Hypertension App to Improve Hypertension Control and Cardiovascular Health Among African-Americans: A Decentralized Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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