Hypertension, or high blood pressure, is a major cause of preventable illness and premature death, affecting millions in the UK. Despite effective treatments, many patients struggle to achieve adequate blood pressure control. This study evaluates the effectiveness of the OptiZ. OptiZ is a mobile phone application ("app") intended to be installed on a mobile device as part of a treatment for hypertension for use by patients prescribed Zestril (lisinopril). The OptiZ app helps patients record blood pressure, dose-related side effects, and medication adherence, send reports to healthcare professionals for dose adjustments, set reminders to log their medication and blood pressure readings, and access information about high blood pressure and health tips. This is a real-world observational study involving adults diagnosed with essential hypertension who are eligible for Zestril treatment. Recruitment will occur at selected GP practices across England over six months, with participants followed for 12 months. The study aims to enrol 113 participants. Using the OptiZ app, participants will record daily blood pressure readings, track medication adherence, record dose-related side effects, and access educational content on hypertension management. Healthcare professionals will use reports generated by the app to personalise Zestril dosing. The main objective is to evaluate the OptiZ app's impact on reducing systolic blood pressure during the dose adjustment phase. Secondary objectives include adherence to Zestril, how often patients log blood pressure readings onto the OptiZ app and other patient-reported outcomes. Participants will also complete electronic questionnaires to provide feedback on their experience using the OptiZ app and their perceptions of hypertension treatment. This study is funded by Closed Loop Medicine Ltd and Atnahs Pharma UK Ltd. The findings aim to improve hypertension care by using digital tools to enhance adherence, optimise dosing, and potentially reduce cardiovascular risks while guiding future digital solutions for chronic conditions.
Study Type
OBSERVATIONAL
N/A, this is an observational study.
Oak Street Medical Practice
Norwich, United Kingdom
Change in systolic blood pressure
The change in systolic blood pressure from baseline to the end of the titration period.
Time frame: 12 months
Mean change in diastolic blood pressure
Mean change in DBP from baseline to the end of titration period
Time frame: 12 months
Number and percentage of participants achieving target Home Blood Pressure at the end of their titration period
The number and percentage of participants achieving target HBP (home SBP \[HSBP\] less than 135 and home DBP \[HDBP\] less than 85 mmHg for adults aged under 80; below 145/85 mmHg for adults aged 80 and over) at the end of their titration period. with subsequent assessments at 4 months post successful titration and the end of the study (8-month follow-up).
Time frame: 12 months
Median time from baseline to first achieving Home Blood Pressure control
Median time from baseline to first achieving Home Blood Pressure control
Time frame: 12 months
Participants' daily adherence to Zestril
Participants' daily adherence to Zestril, assessed using the OptiZ App, with adherence success defined as adherence to prescribed medication on 80% or more days during the titration period.
Time frame: 12 months
Adherence to collecting data using the OptiZ App
Adherence to collecting data using the OptiZ App will be determined by the percentage of the titration period during which participants input data into the OptiZ App. Success will be defined as achieving 80% or more data input
Time frame: 12 months
Proportion of participants requiring re-entry into the titration phase at follow-up due to uncontrolled blood pressure
Proportion of participants requiring re-entry into the titration phase at follow-up due to uncontrolled blood pressure defined as home BP average of ≥135/85 mmHg for adults under 80 and ≥145/85 mmHg for those 80 and older.
Time frame: 12 months
Healthcare professionals' concordance to the OptiZ treatment report recommendations
Healthcare professionals' concordance to the OptiZ treatment report recommendations assessed using self-reported data via an e-questionnaire after each consultation visit with a participant
Time frame: 12 months
Participant's feedback using Brief Illness Perception Questionnaire
Participant's thoughts and emotions about treatment assessed using the Brief Illness Perception Questionnaire (B-IPQ) (consisting of 8 questions answered on a scale from 0 to 10 however each question is asked whereby a different a score of 0 or 10 is not consistently a better outcome; and a final question asking the participant to rank the 3 most important factors that they believe caused their illness) at baseline, end of titration period and 4-month follow up
Time frame: 8 months
Number and percentage of participants discontinuing Zestril due to unwanted side effects
Number and percentage of participants discontinuing Zestril due to unwanted side effects (or other clinically significant reasons as determined by the responsible healthcare professionals) assessed using data collected from medical notes and withdrawal forms
Time frame: 12 months
Number and type of spontaneously reported unwanted side effects
Number and type of spontaneously reported unwanted side effects, assessed using data reported during each consultation and from medical notes.
Time frame: 12 months
User experience and feedback on the OptiZ treatment
User experience and feedback on the OptiZ treatment assessed using the User Experience Questionnaire (UEQ) used to measure user experience with 6 scales (Attractiveness, Efficiency, Perspicuity, Dependability, Stimulation and Novelty) (where questions are answered on a scale from 1 to 7 but a score of 1 or 7 does not necessarily result in a better outcome). This questionnaires will be administered at the end of titration period and 4-month follow up.
Time frame: 8 months
User experience and feedback on the OptiZ treatment
User experience and feedback on the OptiZ treatment assessed using the UMUX-Lite questionnaire tailored to evaluate the specific components and features of the OptiZ App (consisting of 6 sections which all contain 2 questions where each question is answered using 'strongly agree', 'disagree', 'slightly agree', 'neither agree or disagree', 'slightly agree', 'agree', 'strongly agree' as well as a question for each section asking the participant why those scores were given). This questionnaires will be administered at the end of titration period and 4-month follow up.
Time frame: 8 months
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