No primary outcome results reported as this publication is a study protocol awaiting trial completion.
RCT (n=542)
Open-label for participants and practitioners; blinding maintained for laboratory staff analyzing urine samples and some data collectors
Permuted blocks with randomly varied block sizes of 4 and 6, stratified by practitioner
Yes
Does a very brief nurse-delivered intervention followed by a digital intervention reduce systolic blood pressure in primary care patients with poorly controlled hypertension?
Introduction Hypertension is a global health challenge accounting for 8.5 million deaths worldwide despite the availability of low-cost pharmaceutical treatment. About 14.9% of people (9.9 million) registered with primary care practices in England and Wales are prescribed medication for hypertension. However, many patients with hypertension and associated conditions do not take their medications as prescribed. Non-adherence to antihypertensive medication is associated with increased risk of suboptimal blood pressure (BP) control, complications and all-cause mortality, and increased healthcare costs. The Programme on Adherence to Medication (PAM) trial will estimate the effectiveness and cost-effectiveness of a medication adherence intervention in patients prescribed medication for hypertension with poorly controlled blood pressure in primary care. Methods A two-arm multicentre individually randomised controlled parallel group superiority trial recruiting patients prescribed medication for hypertension with poorly controlled BP in primary care practices in England and Wales. The target sample size is 542. Participants in the Intervention group will receive a very brief intervention delivered remotely (by telephone or video call) by a practice nurse or healthcare assistant followed by a digital intervention (text messaging or smartphone app) in addition to usual care; control group participants will receive usual care alone. The primary outcome is systolic BP measured at 12 months. Medication adherence will be measured by chemical adherence testing of urine samples and self-report. An economic evaluation and a process evaluation will be undertaken. Ethics and dissemination The Cambridge East Independent Research Ethics Committee (REC reference 19/EE/0354), the Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approved the trial. The findings will be disseminated to the scientific community, participating practitioners and patients, relevant patient groups and the public using a range of methods, including journal articles, conference presentations, newsletters and the Programme website. Trial registration number The UK’s Clinical Trial Registry ISRCTN82013652
Sutton et al. (Wed,) conducted a rct in Adults prescribed medication for hypertension with poorly controlled blood pressure in primary care practices in England and Wales (n=542). Programme on Adherence to Medication (PAM) intervention vs. Usual care alone was evaluated on Change in systolic blood pressure at 12 months measured by participant self-monitoring at home. No primary outcome results reported as this publication is a study protocol awaiting trial completion.