OUTREACH: Urine Analysis and Antihypertensive Treatment
- Conditions
- HypertensionAdherence, Medication
- Interventions
- Other: Standard careOther: HPLC-MS/MS-guided intervention
- Registration Number
- NCT03293147
- Lead Sponsor
- University of Manchester
- Brief Summary
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our project will assess whether high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence) leads to an improvement in blood pressure control, adherence and a reduction in healthcare costs. Our multicentre prospective randomised controlled trial consists of 6 stages (screening, recruitment, baseline phenotype assessment, intervention, short-term and long-term outcome visits). The study will fill in an important gap in knowledge on management of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step. It will also inform the development of a cost-effective model for the management of non-adherence in chronic disorders that require long-term drug therapy.
- Detailed Description
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood pressure control and translates into increased risk of cardiovascular morbidity and mortality. Currently, there is no effective intervention for therapeutic non-adherence.
An ultra-sensitive and highly specific biochemical assay has been developed to detect urinary biomarkers of antihypertensive treatment. The high performance liquid chromatography mass spectrometry (HPLC-MS/MS)-based assay screens spot urine samples for the presence of 40 commonly prescribed blood pressure lowering medications. The results of the test provide a clinician with information on the presence/absence of prescribed antihypertensive drugs or/and their metabolites in urine - a direct confirmation of therapeutic adherence/non-adherence.
The study is a prospective multi-centre randomised controlled trial to examine if HPLC-MS/MS-guided intervention is superior to standard clinical care in improving clinical, behavioural and health-economy outcomes in hypertensive patients who are non-adherent to antihypertensive treatment.
Patient adherence to antihypertensive treatment will be determined at baseline. Non-adherent hypertensive patients at baseline will be randomised in a 1:1 ration to either usual clinical care plus HPLC-MS/MS-guided intervention (Arm A) or usual clinical care only (Arm B).
The study also evaluates a cohort of patients who are adherent to antihypertensive treatment at baseline. Those adherent hypertensive patients will receive the usual clinical care (Arm C). The main purpose of involving this group of patients is to blind the clinical research staff to the adherence status of those patients randomised receiving standard care alone, to prevent introducing any bias in treating non-adherent patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Male or female aged 18 years or above
- Patients previously diagnosed with and pharmacologically managed for hypertension
- Patients with antihypertensive treatment with at least two antihypertensive medications
- Patients have full capability of providing informed consent
-
Patients with recent history of admission to the hospital relating to their hypertension or treatment with anti-hypertensive medications (<2 weeks) (i)
-
Patient refusal for 7-day home-based blood pressure monitoring (7-HBBPM)
-
Self-reported pregnancy or breastfeeding
-
Female patients planning to conceive within the next 6 months
(i) Including admission to A&E
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C Standard care Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care. Arm A HPLC-MS/MS-guided intervention Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention. Arm B Standard care Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care.
- Primary Outcome Measures
Name Time Method Change in Clinic systolic blood pressure visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct) Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
- Secondary Outcome Measures
Name Time Method Change in urinary albumin / creatinine ratio visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct) Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
Change in clinic diastolic blood pressure visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct) Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
Change in biochemical adherence of patients visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct) HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.
Change in clinic systolic blood pressure visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct) Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
Changes in health economy parameters visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct) Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
Change in home blood pressure visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct) This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).
Trial Locations
- Locations (12)
University College London Hospitals NHS Foundation Trust
🇬🇧London, Greater London, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, Greater Manchester, United Kingdom
Glenfield General Hospital
🇬🇧Leicester, United Kingdom
Alvaston Medical Centre
🇬🇧Derby, United Kingdom
Epsom & St. Helier University Hospitals NHS Trust
🇬🇧Epsom, United Kingdom
Guy's and St Thomas' Hospital
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Homerton Hospital
🇬🇧London, United Kingdom
St Bartholomews Hospital
🇬🇧London, United Kingdom
University Hospitals Dorset NHS Foundation Trust
🇬🇧Poole, United Kingdom
Chilwell Valley and Meadows Practice
🇬🇧Nottingham, United Kingdom