OUTREACH: Urine Analysis and Antihypertensive Treatment

NCT03293147 | Completed

• 1 other identifier: R120993
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 12

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.

Conditions

Hypertension; Adherence, Medication

Keywords

Blood pressure; Antihypertensive treatment; Adherence; Biomarker; Urine; HPLC-MS/MS

Outcome Measures

Primary Outcomes (1)

• Change in Clinic systolic blood pressure

  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

  visit 4 (short term follow-up; approx. 3 months post intervention, when feasible to conduct)

Secondary Outcomes (12)

• Change in clinic systolic blood pressure

  visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)

• Change in clinic diastolic blood pressure

  visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)

• Change in clinic diastolic blood pressure

  visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)

• Change in home blood pressure

  visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)

• Change in home blood pressure

  visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)

Other Outcomes (2)

• Changes in psychological profile

  visit 4 (short term follow-up; ~3 months post intervention, when feasible to conduct)

• Changes in psychological profile

  visit 5 (long term follow-up; ~4.5 months post intervention, when feasible to conduct)

Study Arms (3)

Arm A

EXPERIMENTAL

Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention.

Other: HPLC-MS/MS-guided intervention

Arm B

ACTIVE COMPARATOR

Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care.

Other: Standard care

Arm C

ACTIVE COMPARATOR

Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care.

Other: Standard care

Interventions

HPLC-MS/MS-guided intervention OTHER

The HPLC-MS/MS-guided intervention consists of providing partially or totally non-adherent hypertensive patients with information on the results of their HPLC-MS/MS-based urine analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment

Arm A

Standard care OTHER

Standard care for hypertensive patients

Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• British Heart Foundation: collaborator
• Manchester Academic Health Science Centre: collaborator
• Omron Healthcare Co., Ltd.: collaborator

Study Sites (12)

University College London Hospitals NHS Foundation Trust

London, Greater London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD2 1SY, United Kingdom

Location

Alvaston Medical Centre

Derby, DE24 0GE, United Kingdom

Location

Epsom & St. Helier University Hospitals NHS Trust

Epsom, KT17 1HB, United Kingdom

Location

Glenfield General Hospital

Leicester, LE3 9QP, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Guy's and St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Homerton Hospital

London, United Kingdom

Location

St Bartholomews Hospital

London, United Kingdom

Location

Chilwell Valley and Meadows Practice

Nottingham, NG9 6DX, United Kingdom

Location

University Hospitals Dorset NHS Foundation Trust

Poole, BH15 2JB, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maciej Tomaszewski, Prof., MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and clinicians will initially be blinded to the result of the baseline (at trial entry) HPLC-MS/MS based urine test to determine the participant adherence to antihypertensive treatment. Non-adherent patients allocated to Arm A will be un-blinded at the stage of visit 3 where the results of their HPLC-MS/MS urine test will be revealed to them as a part of HPLC-MS/MS-guided intervention. The doctor will also require un-blinding to provide the required intervention. However, during further study visits the research personnel will remain blinded as to the adherence status of these patients, the results of their HPLC-MS/MS-based analysis and the treatment allocation. The doctor who delivers the intervention will not be involved in collecting clinical information necessary to define outcomes during appointments 4 and 5. Hypertensive patients randomised to Arms B and C will remain blinded to the results of their HPLC-MS/MS-based urine test throughout all stages of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine

Model Details: Multi-center randomised controlled trial

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: December 18, 2018
• Primary Completion: August 4, 2023
• Study Completion: September 30, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)