Condition category
Circulatory System
Date applied
21/08/2014
Date assigned
20/10/2014
Last edited
23/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Treatment in Morning versus Evening (TIME) is a study to compare the treatment for high blood pressure using hypertensive drugs given in the evening with the usual morning medication. This is done using an online system to record any side effects or changes due to the change in their medication. This automated system has worked well in our initial phase of this study with good patient response. Record-linkage to hospitalisations and deaths will be carried out and events monitored. Heart attack, stroke or death will be recorded and analysed to see if the timing of the medication has any impact.

Who can participate?
People who are already taking antihypertensive medication in usual care.

What does the study involve?
Participants take part by registering on a secure, study-specific website. Those who are eligible, are randomly allocated to continue taking medication at their usual time (usually morning) or to switch to taking medication in the evening. Subjects receive regular emails with simple links to record responses to track progress. Participants, people on their behalf, or GPs can record any side effects at any time online. Participants are followed up for 4 years.

What are the possible benefits and risks of participating?
Taking hypertensive medication in the evening may reduce the number of heart attack or stroke compared with usual morning dosing, and so is potentially of benefit to all hypertensive patients in the future. We do not think that there are any risks for patients taking part in the study.

Where is the study run from?
The study is sponsored by the University of Dundee, UK and run from the Medicines Monitoring Unit (MEMO) within this. The study is internet based and participants can be recruited from across the UK. They will be recruited from general practices, hospitals or by social media.

When is the study starting and how long is it expected to run for?
August 2011 to May 2019

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

Who is the main contact?
Ms Wendy Saywood
wendys@memo.dundee.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Geraldine Mackle

ORCID ID

Contact details

Dept of Clinical Pharmacology
Division of Medicine and Therapeutics
Level 7
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom
-
gmackle@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17071

Study information

Scientific title

Treatment In Morning versus Evening: an observational study

Acronym

TIME

Study hypothesis

A trial comparing evening dosing of usual antihypertensive therapy with conventional morning dose is proposed.

Ethics approval

East of Scotland Research Ethics Service (EoSRES) REC 1; 28/05/2011 (approval for the pilot study), 26/05/2014 (approval to move on to full study); ref. 11/AL/0309

Study design

Both; Observational; Design type: Not specified

Primary study design

Observational

Secondary study design

Not specified

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

https://www.timestudy.co.uk/info_sheets/TIME%20STUDY%20-%20Patient%20Information%20Sheet.pdf

Condition

Topic: Primary Care, Cardiovascular disease; Subtopic: Other Primary Care, Cardiovascular (all Subtopics); Disease: All Diseases, Other

Intervention

Timing of medication switch: Subjects already taking hypertensive medication in usual care will be identified from collaborating practices and within secondary care clinics. Subjects will be invited to participate in the study by registering on a study website. Registered subjects who meet the inclusion criteria will be randomised to continue taking medicine at their usual time (most often in the morning) or to switch to taking medication in the evening (or morning if evening is their usual time).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The Anti Platelet Trialists' Collaboration: composite endpoint of non-fatal myocardial infarction, non-fatal stroke or vascular death.

Secondary outcome measures

1. Each component of the primary endpoint
2. Hospitalisation for non-fatal stroke
3. Hospitalisation for non-fatal MI
4. Vascular death
5. All-cause mortality
6. Hospitalisation or death from congestive heart failure.

1. Adherence to the evening dosing regimen vs morning (patient reported) with particular reference to patients taking diuretic therapy.
2. Patient reported and hospitalised adverse events in the morning versus evening groups will be compared. In particular falls and fractures will be recorded.
3. Home BP readings taken by a subset of patients will be compared between morning & evening dosing.
4. An additional proposed substudy is a telephone administered cognitive function assessment to compare patients on morning and evening dosing.

Overall trial start date

03/08/2011

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both diagnosed and treated for hypertension (all forms) with at least one antihypertensive drug
2. Aged above 18 years
3. Have a valid email address

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Proposed following AM09: >20,000; Actual number recruited to date: 20,860 (AM09 (REC ref AM11): Approved 22/12/2015)

Participant exclusion criteria

1. Subjects who take twice daily antihypertensive therapy.
2. Subjects who work shift patterns that include a night shift.
3. Subjects who unwilling to consent to:
3.1. Follow up
3.2. Provide a surrogate to be contacted and/or
3.3. Give consent for their family practice to release follow up clinical data
3.4. To have their physical case records abstracted if required
3.5. To have their electronic case records searched and abstracted if required
3.6. To allow their consent from to be copied to authorities from whom the study team is requesting medical data
4. Those participating in another clinical trial or who have done in the last 3 months.

Recruitment start date

03/08/2011

Recruitment end date

04/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

NHS Tayside (UK)

Sponsor details

R&D Office
Level 9
Ninewells Hospital and Medical School
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK); Grant Codes: CS/14/1/30659

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26861939

Publication citations

Additional files

Editorial Notes

23/08/2016: The following changes were made to the trial record: 1. The overall trial end date was changed from 04/07/2016 to 31/05/2019. 2. The target number of participants was changed from 'Planned Sample Size: 10269; UK Sample Size: 10269' to 'Proposed following AM09: >20,000; Actual number recruited to date: 20,860 (AM09 (REC ref AM11): Approved 22/12/2015)'. 10/02/2016: Publication reference added.