Condition category
Circulatory System
Date applied
04/12/2017
Date assigned
07/12/2017
Last edited
07/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
High blood pressure (also called hypertension) is a condition that affects more than 1 in 4 adults. It can strain the heart and the blood vessels, and increase the risk of stroke, heart attack, heart failure, kidney damage, and death. Failure to take medication as prescribed (i.e. non-adherence) is believed to be common in hypertension because it rarely has noticeable symptoms. The patients recruited in this study will be asked to provide a urine sample at the hypertension clinic to find out if they take their blood pressure medication as prescribed. A group of non-adherent patients participate in a simple 5-step (Discuss/Explore/Act/Co-operate/Reinforce) intervention in which the patient and the treating doctor will discuss the test result, the reasons for not taking the medication as prescribed, and useful measures to improve adherence. The aim of this study is to test if the 5-step intervention helps non-adherent patients to comply with their treatment and lower their blood pressure.

Who can participate?
Adults aged 18 and older who have been taking medications for hypertension.

What does the study involve?
Participants taking part in the study will be asked to provide urine samples (four in total), to complete some questionnaires (on three occasions) and also to take an automatic monitor home to check their blood pressure three times in the morning and three times in the evening over a period of seven days (on four occasions). The home-based blood pressure monitors and diaries are returned to the hospital. Adherence, health outcomes and care costs are measured and compared with groups of non-adherent and adherent patients who did not receive the intervention.

What are the possible benefits and risks of participating?
There is no guarantee that this trial will help participants directly but the information obtained from this study may help improve the treatment of people who suffer from high blood pressure and are at risk of heart diseases. The potential benefit of this study will be that hypertensive patients at risk of heart disease may be able to be assessed, diagnosed and treated better. Study participants will have to attend additional visits, however study voucher will be offered to use at the hospital when attending the visits related to the study (parking costs and refreshments). Participants may experience local discomfort on the arm when using the home-based blood pressure monitor if the cuff is of the incorrect size or over inflated. Instructions on how to use the monitor will be provided by the nurse at each visit to reduce the risk.

Where is the study run from?
This study is being run by the Manchester Academic Health Science Centre – Trials Coordination Unit (MAHSC-CTU) (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
September 2017 to September 2021

Who is funding the study?
British Heart Foundation (BHF) (UK)

Who is the main contact?
Mrs Laurence Loubiere

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Laurence Loubiere

ORCID ID

Contact details

Manchester Academic Health Science Centre – Trials Coordination Unit (MAHSC-CTU)
Block C Withington Hall
The Christie Hospital NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36591

Study information

Scientific title

BiOmarkers in Urine, anTihypeRtensive trEAtment and blood pressure Control in Hypertensive patients - OUTREACH Study

Acronym

OUTREACH Study

Study hypothesis

The study hypothesis is that providing partially or totally non-adherent hypertensive patients with information on their biochemical adherence test (HPLC-MS/MS-based urine test) combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment (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.

Ethics approval

Not provided at time of registration.

Study design

Randomised; Interventional; Design type: Treatment, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cardiovascular disease, Primary sub-specialty: Cardiovascular Prevention; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases

Intervention

The study is a prospective multi-centre randomised controlled trial.

Patient adherence to antihypertensive treatment is determined at baseline using an HPLC-MS/MS-based urine test. Participants taking part in the study are asked to sign a consent form and are required to attend up to five visits in the hospital outpatient clinic over the course of one year.

Non-adherent hypertensive patients at baseline are randomised in a 1:1 ratio 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 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.

Patients allocated to arm A receive at visit 3 the HPLC-MS/MS-guided intervention (the study intervention) which consists of providing 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.

Patients allocated to arm B or arm C receive standard care for hypertensive patients at visit 3.

All participants are followed-up three months and nine months after the intervention at visit 4 (short-term follow-up) and visit 5 (long-term follow-up) respectively.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Mean clinic systolic blood pressure (SBP) is measured in clinic with the study M3 blood pressure monitor at baseline and visit 4.

Secondary outcome measures

1. Mean clinic systolic blood pressure (SBP) is measured in clinic with the study M3 blood pressure monitor at baseline and visit 5
2. Mean clinic diastolic blood pressure (DBP) is measured in clinic with the study M3 blood pressure monitor at baseline, visit 4 and visit 5
3. Mean daytime systolic blood pressure is measured in at home over a 7 days period with the study M3 blood pressure monitor at baseline, visit 4 and visit 5
4. Mean daytime diastolic blood pressure is measured in at home over a 7 days period with the study M3 blood pressure monitor at baseline, visit 4 and visit 5
5. Biochemical adherence is measured using the HPLC-MS/MS test on spot urine samples collected at baseline, visit 4 and visit 5
6. Urinary biomarker of target organ damage is measured by the urinary albumin / creatinine ratio (ACR) at baseline, visit 4 and visit 5
7. Patient quality of life is measured with the validated EQ-5D-3L questionnaire at baseline, visit 4 and visit 5
8. Patient wellbeing is measured with validated ICECAP-A at baseline, visit 4 and visit 5
9. The costs of clinical/social care patient is measured with the health care resource patient questionnaire (including primary and secondary care) at baseline, visit 4 and visit 5

Tertiary outcome measures:
1. Adherence conversion rate is measured the HPLC-MS/MS test on spot urine samples collected at baseline and visit 2
2. Patient’s psychological profile is assessed by several questionnaires at baseline, visit 4 and visit 5:
2.1. Patient’s anxiety and depression profile is measured by the Hospital anxiety and depression Score (HADS)
2.2. Patient's perception of their illness is measured by the Brief illness perception questionnaire (B-IPQ)
2.3. Patient’s self-reported adherence to antihypertensive medications is measured by the Medication Adherence Report scale (MARS-5)
2.4. Patient’s main beliefs influencing antihypertensive medications intake is measured by the Belief about medicines questionnaire specific to hypertension (BMQ-Specific-11-hypertension) and the Belief about medicines questionnaire general combined with the perceived sensitivity to medicines (combined BMQ G12 & PSM)
2.5. Patients’ perceptions of the intrusiveness of antihypertensive medications is measured by the Treatment Intrusiveness Scale (TIS)

Overall trial start date

30/09/2017

Overall trial end date

01/09/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged 18 years or above (min age 18 years old; no maximum age)
2. Patients previously diagnosed with and pharmacologically managed for hypertension
3. Patients with antihypertensive treatment with at least two antihypertensive medications
4. Patients willing and able to give informed consent for study inclusion including all study assessments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 321; UK Sample Size: 321

Participant exclusion criteria

1. Recent history of admission to the hospital (< 2 weeks of baseline visit , including admission to A&E),
2. Recent change in the prescribed antihypertensive medications (< 2 weeks of baseline visit). Changes in antihypertensive drug dose are not considered an exclusion criteria if this is the only change within 2 weeks of the baseline visit.
3. Refusal for 7-day home based blood pressure monitoring
4. Self-reported pregnancy or breastfeeding
5. Female patients planning to conceive within the next 12 months

Recruitment start date

03/09/2018

Recruitment end date

02/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Glenfield General Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Trial participating centre

University College Hospital
235 Euston Road Bloomsbury
London
NW1 2BU
United Kingdom

Trial participating centre

St Thomas' Hospital, London
Westminster Bridge Road Lambeth
London
SE1 7EH
United Kingdom

Trial participating centre

King’s College Hospital, London
Denmark Hill Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

The Queen Elizabeth Hospital Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Ninewells Hospital
James Arrott Drive
Dundee
DD2 1SY
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

The University of Manchester

Sponsor details

The University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study will be submitted for presentation at scientific and clinical meetings and for publication in high-impact peer-reviewed periodicals.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/08/2021

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes