HYPERTESSA HyperTessa User Experience Study (HTUX) - Trial NCT06380712

Timeline & Enrollment

Primary Outcome

User Experience / User Acceptance Indicators for patients

Summary

Background: Hypertension is the primary cause of cardiovascular diseases and premature death
 in the world. Hypertension management starts with the control of blood pressure, whatever it
 is the type and severity. The optimum control of blood pressure requires regular and frequent
 auto-monitoring of blood pressure values, adherence to medication plan, and modification of
 lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a
 pilot project to assess acceptance ad usability of a digital health solution to be used by
 patients diagnosed with hypertension. Materials and methods: Prior to the development of the
 solution, a literature research was performed, then focus group meetings were conducted with
 senior experts in the digital field, physicians treating hypertension, and patients. A mobile
 app and web platform were created to help patients in monitoring and reporting data about
 health status and lifestyle. In order to execute the study, first the physicians in charge of
 the study will register in the webApp, creating a personal account. Then, patients who meet
 the inclusion criteria are proposed to participate to the study and, in case of agreement,
 will be asked to sign the informed consent (IC) statement and the privacy policy. After the
 phase of profile setting and onboarding, the patient will start to use the mobile App for
 hypertension management. Once the patient has used the App for the observation period, the
 physician will be allowed to analyze the data to understand the level of acceptance and
 regular usage from each patient. This physician will perform this analysis using a web-based
 portal which is part of the digital solution. Results: During the study, data about usage
 patterns will be collected. Specific data about usability and acceptance will be gathered
 through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests.
 After each patient has completed the observation period, all the data will be analysed using
 mainly descriptive statistics to obtain metrics related to usage patterns, usability and
 adherence. The study results from this pilot phase will be used to modify the digital
 solution, leveraging an incremental, iterative logic following a co-design and agile
 methodology. After incorporating the feedback from this pilot and further enriching the
 solution, next phases of the study are forseen in order to assess the care benefit of such
 technology in terms of improved treatment outcomes, due to better adherence, higher
 motivation in practicing healthy lifestyle, better information, and personalized support from
 HCP.

ICD-10 Classifications