OUTREACH study: Urine analysis and antihypertensive treatment
| ISRCTN | ISRCTN15911100 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15911100 |
| IRAS number | 229352 |
| ClinicalTrials.gov number | NCT03293147 |
| Secondary identifying numbers | CPMS 36591, IRAS 229352 |
- Submission date
- 04/12/2017
- Registration date
- 07/12/2017
- Last edited
- 16/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 are 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 disease. 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, a 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?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
September 2017 to September 2023
Who is funding the study?
British Heart Foundation (BHF) (UK)
Who is the main contact?
Marta Ahmed (Project Manager)
OUTREACH1@manchester.ac.uk
Contact information
Scientific
Project Manager
The University of Manchester
AV Hill Building
Upper Brook Street
Manchester
M13 9LJ
United Kingdom
| Phone | +44 (0)161 275 1227 |
|---|---|
| OUTREACH1@manchester.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | BiOmarkers in Urine, anTihypeRtensive trEAtment and blood pressure Control in Hypertensive patients - OUTREACH Study |
| Study acronym | OUTREACH |
| 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(s) | Approved 20/12/2017, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ; Email: nrescommittee.northwest-gmsouth@nhs.net), REC ref: 17/NW/0637 |
| Condition | Hypertension |
| 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 to the hospital outpatient clinic over the course of 1 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. Previous: All participants are followed-up 3 months and 9 months after the intervention at visit 4 (short-term follow-up) and visit 5 (long-term follow-up) respectively. Updated 11/03/2021: All participants are followed-up approximately 12 weeks and 20 weeks after the intervention at visit 4 (short-term follow-up) and visit 5 (long-term follow-up) respectively, or at first availability. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 30/09/2017 |
| Overall study end date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 240; UK Sample Size: 240 |
| Total final enrolment | 879 |
| 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 exclusion criteria | Current exclusion criteria as of 07/12/2022: 1. Recent history of admission to hospital relating to their hypertension or treatment with antihypertensive medications (< 2 weeks of baseline visit, including admission to A&E) 2. Refusal for 7-day home-based blood pressure monitoring 3. Self-reported pregnancy or breastfeeding 4. Female patients planning to conceive within the next 6 months Previous exclusion criteria from 11/03/2021 to 07/12/2022: 1. Recent history of admission to hospital relating to their hypertension or treatment with antihypertensive medications (< 2 weeks of baseline visit, including admission to A&E) 2. Refusal for 7-day home-based blood pressure monitoring 3. Self-reported pregnancy or breastfeeding 4. Female patients planning to conceive within the next 12 months Original 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 criterion 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 | 18/12/2018 |
| Recruitment end date | 04/02/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Manchester
M13 9WL
United Kingdom
Leicester
LE3 9QP
United Kingdom
Lambeth
London
SE1 7EH
United Kingdom
Dundee
DD2 1SY
United Kingdom
KT17 1HB
United Kingdom
London
E9 6SR
United Kingdom
London
NW3 2QG
United Kingdom
Barts and The London School of Medicine and Dentistry
Charterhouse Square
London
EC1M 6BQ
United Kingdom
London
NW1 2PQ
United Kingdom
Ranson Road
Chilwell
Nottingham
NG9 6DX
United Kingdom
Alvaston
Derby
DE24 0GE
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Sponsor information
University/education
The University of Manchester
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
16/10/2024: The following changes were made:
1. The intention to publish date was changed from 31/12/2023 to 31/08/2025.
2. The total final enrolment number was added.
08/12/2022: The following changes were made to the trial record:
1. IRAS number added.
2. The recruitment start date was changed from 01/12/2018 to 18/12/2018.
3. The overall trial end date was changed from 04/08/2023 to 30/09/2023.
07/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 04/05/2022 to 04/02/2023.
2. The overall trial end date was changed from 04/07/2023 to 04/08/2023.
3. The contact details and exclusion criteria were updated.
4. UCLH, Chilwell Valley and Meadows Practice, Alvaston Medical Centre and University Hospitals Dorset NHS Foundation Trust were added to the trial participating centres.
02/11/2022: The following changes have been made:
1. The overall trial end date has been changed from 04/11/2022 to 04/07/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 04/01/2023 to 31/12/2023.
21/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 04/12/2021 to 04/05/2022.
2. The overall end date was changed from 04/06/2022 to 04/11/2022.
3. The intention to publish date was changed from 04/08/2022 to 04/01/2023.
4. The plain English summary was updated to reflect these changes.
20/09/2021: Internal review.
12/03/2021: Contact details updated.
11/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2019 to 04/12/2021.
2. The overall trial end date was changed from 01/09/2021 to 04/06/2022.
3. The intention to publish date was changed from 30/08/2021 to 04/08/2022.
4. The interventions and exclusion criteria were updated.
5. Trial website added.
6. The target number of participants was changed from Planned Sample Size: 321; UK Sample Size: 321 to Planned Sample Size: 240; UK Sample Size: 240.
7. Homerton University Hospital, Royal Free Hospital and St Bartholomew's Hospital were added and University College Hospital, King’s College Hospital, The Queen Elizabeth Hospital Birmingham, Western General Hospital, Guy’s and St Thomas' Hospital were removed as trial participating centres.
26/04/2019: Ethics approval details added, contact details updated.
25/04/2019: The following changes were made to the trial record:
1. Contact details updated.
2. ClinicalTrials.gov number added.
3. The recruitment start date was changed from 03/09/2018 to 01/12/2018.
4. The recruitment end date was changed from 02/09/2019 to 01/12/2019.
5. Trial participating centres added.
29/03/2019: The condition has been changed from "Specialty: Cardiovascular disease, Primary sub-specialty: Cardiovascular Prevention; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases" to "Hypertension" following a request from the NIHR.
13/07/2018: The following changes were made to the trial record:
1. The primary contact was changed from Mrs Laurence Loubiere to Mrs Jessica Atkinson.
2. The plain English summary was updated.
