Pre-hypertension Circulatory System
Conditions
Interventions
Design:
REVERSE is a non-randomised feasibility study to explore whether individuals with raised blood pressure and health care professionals (HCPs) will engage with a study on raised blood pressure (
recruitment and drop-out rates throughout the study, completeness and usefulness of data, participant adherence to the self-monitoring protocol, the fidelity of the study processes, and unintended neg
Sponsors
University of Central Lancashire
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over with no upper age limit 2. Blood pressure between 120-139 mmHg systolic and/or 80-89 mmHg diastolic 3. No previous diagnosis of hypertension (added 08/04/2026) For the HCPs in the interview component - healthcare professionals that had been involved in the study
Exclusion criteria
Exclusion criteria: 1. Prescribed anti-hypertensive medication 2. Previous stroke or myocardial infarction 3. Pregnancy 4. Currently actively self-monitoring blood pressure 5. Life-limiting illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Willingness to engage with the pre-hypertension concept and the self-monitoring intervention, assessed using the number and proportion of services and patients/people approached expressing an interest in taking part at the time of recruitment 2. Acceptability of the intervention and study processes, assessed using service provider and participant interviews after 6 month follow up, covering: 2.1. Opinions and experiences of the study, study processes, and the intervention 2.2. Barriers and facilitators to SM 2.3. Suggested changes and improvements 2.4. Ease of integration into current practice | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates of participants and service providers: 1.1. Proportion of sites enrolled and actively recruiting 1.2. Time taken to recruit the target sample 1.3. Proportion of people who are eligible and proportion who consent to take part Measured during the recruitment period 2. Attrition rates and completeness of data: 2.1. Proportion of people who attend each study timepoint 2.2. Number withdrawing definitively, and from just the intervention 2.3. Reasons for withdrawal 2.4. Proportion of missing data Measured throughout the study 3. Protocol adherence: 3.1. Number, frequency and timing of self-monitored readings 3.2. Correct action taken each month 3.3. Accuracy of recorded readings 3.4. Reasons for non-adherence Measured at 6 month follow up 4. Fidelity of the intervention: 4.1. Competency assessments for HCP recruitment process during the recruitment period 4.2. Competency assessments for research team training delivery during baseline sessions 4.3. Number of participants deemed as competent to self-monitor during baseline sessions 4.4. Proportion of appropriate home readings entered into GP clinical systems after 6 month follow up 5. Incidence and impact of any unexpected negative consequences (UNC): 5.1. Health anxiety assessed using the Health Anxiety Inventory (HAI) short version score at baseline, 6 and 12 months 5.2. Depression assessed using the Patient Health Questionnaire (PHQ) at baseline, 6 and 12 months 5.3. Health care utilisation including consultations, medications and referrals attributable to the intervention at baseline, 6 and 12 months 5.4. Quality of life assessed using the EQ5-D at baseline, 6 and 12 months 6. Willingness to pay regarding self-monitoring assessed using a self-developed willingness to pay questionnaire at 6 months 7. Extent SM encourages lifestyle modification assessed using: 7.1. Simple lifestyle Indicator Questionnaire (SLIQ) score at baseline, 6 and 12 months 7.2. Risk perception score assessed using an ada | — |
Countries
England, United Kingdom
Outcome results
None listed