Condition category
Circulatory System
Date applied
06/03/2017
Date assigned
15/03/2017
Last edited
15/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The population is getting older, with over 3 million people in the UK aged 80 years or older. This means that the number of people living with multiple illnesses and taking lots of tablets to manage these illnesses is increasing. High blood pressure is one of the most common medical conditions in older people and many take two or more drugs to treat it. Recent scientific studies suggest that large reductions in blood pressure and too many drug prescriptions may be associated with an increase in falls and death in older patients, particularly in those suffering from lots of medical conditions. This study aims to assess the safety of reducing the number of drugs prescribed to people aged 80 years or older who have blood pressure in a normal range and are taking two or more medications.

Who can participate?
People over 80 years old who are being prescribed two or more blood pressure medications.

What does the study involve?
Participants are randomly allocated by a computer to one of two groups. Those in the first group continue with their current medication for the duration of the study. Those in the second group have one medication, chosen by their GP, removed. Participants in this group are given the opportunity to measure their blood pressure at home, to see if taking fewer medications causes blood pressure to change. There is a 1 in 2 chance of being in the group taking fewer medications to lower blood pressure. The researcher will ask some questions about background and medical history as well as taking some measurements, including height, weight and blood pressure. Finally participants are asked to complete some simple questionnaires about daily activities and general quality of life. Some patients may also be asked if these initial visits with the GP and trained researcher may be tape-recorded. This may happen whether the patient goes on to agree to take part in the trial or not. The recordings will help the research team to better understand what happens in these discussions and make sure patients are able to ask all the questions they need when deciding whether to take part in the trial. The trial will be conducted over 12 weeks and participants need to attend their GP surgery for follow up appointments at week 4 (in the stopping medication group) and week 12 (a minimum of 3 visits to the GP surgery). The doctor may wish to book further appointments in addition to these. At each follow up visit the participant has their blood pressure measured and depending on the reading, the GP or nurse may adjust the participant’s medication again. At the final visit (week 12), participants are asked to complete the same questionnaires completed at the first visit again.

What are the possible benefits and risks of participating?
If participants are in the group who are cutting down their medications, then they may benefit from a reduced risk of falls or other side effects which could affect your quality of life. For participants who continue as normal, there are no direct benefits of taking part. There is a risk that blood pressure may increase when patients stop taking one of their blood pressure medications but this is closely monitored.

Where is the study run from?
1. Thames Valley and South Midlands CRN (UK)
2. Wessex CRN (UK)
3. CRN Eastern (UK)

When is the study starting and how long is it expected to run for?
July 2016 to May 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Eleanor Temple
optimise@phc.ox.ac.uk

Trial website

https://www.phc.ox.ac.uk/research/hypertension/monitoring-and-self-monitoring/optimising-treatment-for-mild-systolic-hypertension-in-the-elderly-optimise

Contact information

Type

Public

Primary contact

Ms Eleanor Temple

ORCID ID

Contact details

Nuffield Department of Primary Care Health Sciences
University of Oxford Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom

Additional identifiers

EudraCT number

2016-004236-38

ClinicalTrials.gov number

Protocol/serial number

33014

Study information

Scientific title

OPtimising Treatment for MIld Systolic hypertension in the Elderly: a randomised controlled trial

Acronym

OPTiMISE

Study hypothesis

The aim of this study is to assess the safety of reducing the number of drugs prescribed to older people (defined as being aged 80 years or older) who have blood pressure in a normal range and are taking two or more blood pressure medications.

Ethics approval

South Central - Oxford A Research Ethics Committee, 12/12/2016, ref: 16/SC/0628

Study design

Randomised; Both; Design type: Treatment, Process of Care, Drug, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Primary Care, Primary sub-specialty: Ageing; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases

Intervention

Participantss are randomised in a 1:1 ratio to medication reduction (intervention) vs usual care (control).

Intervention arm: GP's will choose the most appropriate blood pressure medication to withdraw for those randomised to the medication reduction arm. Participants will be invited to self-monitor their blood pressure, reporting any consistently high readings to their GP (see specific self-monitoring guidance below). All individuals will be asked to attend a routine safety follow-up visit with their GP or nurse, four weeks (±2 weeks) after randomisation.

Control arm: Participants receive usual care only for the duration of the study.

All patients will attend a 12 week (±2 weeks) follow-up with the trial facilitator, either at their GP practice or at their home; the trial facilitator will repeat all measurements taken at baseline. After 12 week follow-up the trial will formally end, but passive long-term follow-up of mortality and hospital admissions will be undertaken via NHS Digital’s patient tracking service.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Proportion of patients with controlled blood pressure levels is measured by taking blood pressure readings at baseline and 12 weeks.

Secondary outcome measures

1. Proportion of patients randomized to the intervention arm who maintain medication reduction throughout is assessed by asking the patient if they have taken any withdrawn medication since the baseline visit, at the 12 week appointment
2. The difference in quality of life between the two groups is measured using the EQ-5D-5L score at baseline and 12 weeks
3. The difference in frailty between the two groups is measured using the FRAIL scale score/frailty index at baseline and 12 weeks
4. The mean difference in the change in mean clinic systolic blood pressure (from baseline) between the two groups at 12 week follow up is measured by taking blood pressure readings at baseline and 12 weeks
5. The difference in the proportion of patients reporting potential side effects to medication (e.g. coughs, dizziness, syncope, ankle swelling, etc.) between the two groups at 12 week follow up is measured by collecting details of side effects from the patient at 12 weeks
6. The difference in the proportion of patients reporting adverse events (hospitalisation due to serious falls, myocardial infarction, stroke or all-cause mortality) between the two groups is measured by collecting details of adverse events from the patient at 12 weeks
7. Characteristics of the baseline screening population, sample population and how these relate to individuals eligible/not eligible for the recent SPRINT trial, using descriptive statistics of screening and baseline populations at baseline

Overall trial start date

01/07/2016

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the trial
2. Male or Female, aged 80 years or above
3. Clinic systolic blood pressure less than 150 mmHg (according to screening measurement at baseline – clinic blood pressure defined as the mean of the 2nd and 3rd readings taken at 1 minute intervals)
4. Prescribed two or more antihypertensive medications to lower blood pressure for at least 12 months prior to trial entry. Antihypertensive medications defined as any ACE inhibitor, angiotensin II receptor blocker, calcium channel blocker, thiazide and thiazide-like diuretic, potassium-sparing diuretic, alpha-blocker or beta-blocker.
5. Stable dose of current antihypertensive medications for at least four weeks prior to trial entry.
6. In the Investigator’s opinion, could potentially benefit from medication reduction due to existing polypharmacy, co-morbidity, non-adherence or dislike of medicines and/or frailty (i.e. is different from those to which the results of the SPRINT trial are likely to apply)
7. In the Investigator’s opinion, is able and willing to comply with all trial requirements

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 540; UK Sample Size: 540

Participant exclusion criteria

Exclusion criteria for the main trial:
1. A participant has heart failure due to LVSD and is on only ACE inhibitors/ARBs and/or beta-blockers and/or spironolactone (removing any of which would be contraindicated).
2. A participant has heart failure but has not had an echocardiogram since its onset (might have undiagnosed LVSD and a compelling need for ACEI/ARB and Betablockers).
3. Investigator deems that there is a compelling indication for medication continuation.
4. Suffered a myocardial infarction or stroke within the past 12 months.
5. Blood pressure being managed outside of primary care.
6. Secondary hypertension.
7. Previous accelerated or malignant hypertension.
8. Unable to provide consent unless a consultee is available to provide assent in cases of incapacity.
9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial (e.g. terminal illness, house bound and unable to attend baseline and follow up clinics).
10. Participants who have participated in another research trial involving antihypertensive medication in the past 4 weeks.

Exclusion criteria for the qualitative study 1:
Capacity to consent and participate in an interview.

Exclusion criteria for the qualitative study 2:
None

Recruitment start date

20/03/2017

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Thames Valley and South Midlands CRN
Block 8, Nuffield Orthopaedic Centre, Windmill Road, Headington
Oxford
OX3 7LD
United Kingdom

Trial participating centre

Wessex CRN
Sovereign Room, Unit 7, Berrywood Business Village, Tollbar Way, Hedge End
Southampton
SO30 2UN
United Kingdom

Trial participating centre

CRN Eastern
20 Rouen Road
Norwich
NR1 1QQ
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
+44 1865 572245
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

All research outputs from this work will be published in peer-reviewed journals. Study findings will be presented at regional, national and international conferences to ensure maximum dissemination amongst academic and clinical colleagues. ‘Patient friendly’ study summary documents and infographics will be made available to all participants at the end of the trial via the study website and distributed to relevant patient groups (e.g British Heart Foundation, Age UK), ensuring widespread dissemination amongst service users.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from optimise@phc.ox.ac.uk

Intention to publish date

31/05/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes