NIHR open research · 2026
Randomised controlled trial of a very brief nurse-delivered intervention followed by a digital intervention to support medication adherence and reduce blood pressure in people prescribed treatment for hypertension in primary care: protocol for the Programme on Adherence to Medication (PAM) trial.
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Sutton Stephen, Jamison James, Beardsell Katja, Fineberg Micah, Conceição Raquel, Mirzaei Venus, Trama Alvarez Catalina, Shpendi Sonia, Brimicombe James, Bhattacharya Debi, Hardeman Wendy, Naughton Felix, Van Emmenis Miranda, Eborall Helen, De Simoni Anna, Takhar Amrit, Gupta Pankaj, Patel Prashanth, Mascolo Cecilia, Prevost Andrew Toby, Carvalho de Vasconcelos Joana, Mant Jonathan, Griffin Simon, McManus Richard J, Morris Stephen
Аннотация
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.
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.