HYPERTESSA "HyperTessa User Experience Study (HTUX)"

NCT ID: NCT06380712

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2024-10-31

Brief 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.

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Subjects aged 18 years or older;
• Evidence of hypertension, including newly diagnosed, according to the criteria of the European Society of Cardiology (https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Arterial-Hypertension-Management-of);
• Patients currently being treated with antihypertensive drugs (regardless of reported blood pressure values): beta blockers, calcium channel blockers, diuretics (any type), alpha-1 lytics, ACE inhibitors, Sartans (at least 1 drug belonging to at least 1 class of that listed);
• Owners of smartphones with compatible operating system;
• To be enrolled in the study and start observation period, patients will first be asked to test the use of the App for fifteen days, verify with him/her any blocking points, validate full comprehension and confirm willingness to participate (run-in phase);
• Subjects must be able to provide written informed consent.

Exclusion Criteria

• Patients who need to take medication therapy more than twice a day;
• Pregnant patients or women planning to conduct a pregnancy during the course of the study;
• Diagnosis of persistent or permanent atrial fibrillation;
• Subjects with advanced renal failure (eGFR ≤ 15 ml/min/1.73 m2, estimated by MDRD formula) on dialysis treatment (hemodialysis or peritoneal dialysis);
• Subjects with advanced forms of hearing loss such that they are unable to sustain a telephone or face-to-face conversation easily;
• Subjects unable to speak fluently Italian language;
• Patients undergoing chemotherapy and/or radiation treatment or for whom one and both of these treatments are scheduled to begin during the study;
• Diagnosis of terminal cancer (whether or not radio/chemotherapy treatment is present);
• Diagnosis of dementia;
• Diagnosis of psychosis;
• Diagnosis of mental impairment;
• Subjects with heart failure with NYHA functional class III or IV;
• Patients with congenital heart disease, hypertrophic cardiomyopathy and severe aortic stenosis;
• Patients with recent (within 90 days of enrollment date) acute cardio-cerebrovascular event (unstable angina, STEMI and NSTEMI type myocardial infarction, TIA, stroke) and/or with recent (within 90 days of enrollment date) invasive procedure (coronary angioplasty, carotid angioplasty, coronary artery bypass grafting, any other cardiac surgery for which extracorporeal circulation was used);
• Established or suspected forms of secondary hypertension;
• Subjects enrolled in other studies;
• Evidence of severe forms of hypertension, according to the criteria of the European Society of Cardiology (https://www.escardio.org/Guidelines/Clinical-Practice Guidelines/Arterial-Hypertension-Management-of);
• Systolic blood pressure, assessed by noninvasive method (sphingomanometer), ≥ 180 mmHg;
• Diastolic blood pressure, assessed by noninvasive method (sphingomanometer), ≥ 110 mmHg.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Flex Andrea

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Flex, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli., IRCCS

Rome, , Italy

Countries

Italy

Central Contacts

Andrea Flex, MD, PhD

Role: CONTACT

andrea.flex@policlinicogemelli.it

+ 39 06 3015 4293

Facility Contacts

Andrea Flex, MD, PhD

Role: primary

andrea.flex@policlinicogemelli.it

+ 39 06 3015 4293

Other Identifiers

6509

Identifier Type: -

Identifier Source: org_study_id