Topic: Primary Care, Cardiovascular disease
Conditions
Interventions
Interventions as of 19/05/2016:
574 (updated to 610 22/01/18) participants will be randomised to usual care (UC) and the HOME BP intervention arm (1:1):
1. HOME BP: Patients will have access to HOME B
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Adult patients (at least 18) with uncontrolled hypertension (patients with a reading of >140/90 mmHg at baseline before randomisation), who are currently receiving medication for hypertension control 2. Patients must have access to the internet Healthcare Practitioners: 1. Employed in primary care setting 2. Involved in treating/managing patients with high blood pressure and enrolled on the HOME BP programme
Exclusion criteria
Exclusion criteria: 1. Inability to self monitor (including diagnosis of dementia) 2. Mean baseline Bblood pressure >180/110 mmHg 3. Prescribed mMore than three antihypertensive medications 4. Hypertension not managed by family doctor 5. Terminal disease or other condition which in the opinion of the family doctor makes them inappropriate to take part 6. Patients with an acute cardiovascular event in the last 3 months 7. Postural hypotension (>20mmHg systolic drop after 1mn standing) 8. Pregnant or breast feeding 9. Patients with a history of proteinuria 10. Atrial fibrillation (or irregular heartbeat) 11. CKD stage 34-5 diagnosis or CKD stage 3 not managed by GP 12. Household member already enrolled on the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic BP (mean of 2nd and 3rd BP readings); Timepoint(s): 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/05/2016: 1. Systolic and diastolic BP; Timepoint(s) 6 and 12 months 2. Prescribing data and consultations; Timepoint(s) 12 months 3. Patient medication use (number and defined daily doses); Timepoint(s) 6 and 12 months 4. Health-related quality of life; Timepoint(s) 6 and 12 months 5. Questionnaire measures on patient enablement Costs of equipment and drugs, Health professional and patient time; Timepoint(s) 12 months Process analysis measures: 1. Questionnaire measure of patient self-efficacy; Timepoint(s) 6 and 12 months 2. Patient medication beliefs, adherence and self-reported side effects; Timepoint(s) 6 and 12 months 3. Patient weight measured within clinic and self-reported lifestyle behaviours; Timepoint 12 months 4. Patient blood pressure (BP) monitoring adherence measured by the HOME BP online system; Timepoint ongoing 5. Utilisation of optional support provision; Timepoint ongoing 6. Digital intervention website usage and engagement, including lifestyle choice, usage and progress; Timepoint ongoing 7. Adherence to recommended medication changes; Timepoint ongoing 8. Prescriber and support provider self-efficacy and outcome expectations; Timepoint baseline 9. Prescriber and support provider confidence in the acceptability of the intervention; Timepoint baseline Previous secondary outcome measures: 1. Systolic and diastolic BP; Timepoint(s) 6 and 12 months 2. Prescribing data and consultations; Timepoint(s) 12 months 3. Patient medication beliefs, adherence, changes and self-reported side-effects; Timepoint(s) 6 and 12 months 4. Questionnaire measures on patient enablement and self-efficacy; Timepoint(s) 6 and 12 months 5. Health-related quality of life; Timepoint(s) 6 and 12 months 6. Costs of equipment and drugs, Health professional and patient time; Timepoint(s) 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactKate Morton
Outcome results
None listed