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NCT06380712
HYPERTESSA "HyperTessa User Experience Study (HTUX)"
trial in Hypertension in 30 participants. Not yet recruiting.
30 September 2024
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 2 May 2024 |
| Primary completion | 30 September 2024 |
| Estimated completion | 31 October 2024 |
| Sites | 1 location across Italy |
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06380712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06380712 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 24 April 2024
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