Measures and schedule of observations within the HOME BP trial
| Time point | |||||
|---|---|---|---|---|---|
| Measure | Baseline/screening | Visit 1 | Visit 2 | Intervention group only | Usual care group only |
| Month | 0 | 6 | 12 | (0–12) | 12 |
| Patient sociodemographic measures | X | ||||
| Frequency of previous self-monitoring | X | X | |||
| Clinical measures | |||||
| Systolic BP (SBP) | X | X | X | ||
| Diastolic BP (DBP) | X | X | X | ||
| Weight (kg) | X | X | |||
| Height (cm) | X | ||||
| Diabetes status | X | ||||
| Hypoglycaemic episodes in last 6 months | X | X | X | ||
| Medication changes (prescriptions issued) | X (NR) | ||||
| Consultations | X (NR) | ||||
| Patient self-report measures | |||||
| Patient enablement instrument | X | X | |||
| Patient self-efficacy | X | X | X | ||
| Beliefs about medication (BMQ) | X | X | X | ||
| Medication adherence (MARS) | X | X | |||
| Patient perceived side effects (IPQ-R hypertension: symptoms subscale) | X | X | |||
| Changes to lifestyle behaviours | X | ||||
| Patient objectively recorded measures | |||||
| Website usage | X* | ||||
| Usage of hypertension pages | X* | ||||
| Monitoring of blood pressure | |||||
| Self-reported SBP | X* | ||||
| Self-reported DBP | X* | ||||
| Medication titration recommended | X* | ||||
| Titration uptake | X* | ||||
| Reasons for non-titration | X* | ||||
| Usage of lifestyle pages | X* | ||||
| Choice of lifestyle changes | X* | ||||
| Reported progress on lifestyle change (eg, weight change) | X* | ||||
| HCP objectively recorded measures | |||||
| Usage of training pages (prescriber guide) | X | ||||
| Emails sent to the patient | X | ||||
| Titration procedure compliance | X | ||||
| Support provision | X | ||||
| HCP self-report measures | |||||
| Self-efficacy and outcome expectations | X† | ||||
| Confidence in the acceptability of the intervention (for patients) | X† | ||||
| Economic measures | |||||
| Patient quality of life (EQ-5D) | X | X | X | ||
| Costs of equipment and drugs | X(NR) | ||||
| Health professional time | X(NR) | ||||
| Patient time | X(NR) | ||||
| Qualitative process analysis | |||||
| Patient experience and views of the HOME BP | X | X | |||
| HCP experience and views of the HOME BP | X | X | |||
*HOME BP intervention arm only—measured throughout the study via HOME BP online.
†Measured directly before and after the HOME BP online training completion.
HOME BP, Home and Online Management and Evaluation of Blood Pressure; NR, notes review.