Treatment in morning versus evening study
| ISRCTN | ISRCTN18157641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18157641 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 17071 |
| Sponsor | NHS Tayside (UK) |
| Funder | British Heart Foundation (BHF) (UK); Grant Codes: CS/14/1/30659 |
- Submission date
- 21/08/2014
- Registration date
- 20/10/2014
- Last edited
- 13/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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. Participants 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. There are no known 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 July 2022
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Ms Wendy Saywood
wendys@memo.dundee.ac.uk
Contact information
Scientific
Medicine Monitoring Unit (MEMO)
University of Dundee
Dundee
DD2 1GZ
United Kingdom
| Phone | +44(0)1382 383437 |
|---|---|
| r.y.barr@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Treatment In Morning versus Evening: an observational study |
| Study acronym | TIME |
| Study objectives | A trial comparing evening dosing of usual antihypertensive therapy with conventional morning dose is proposed. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The Anti Platelet Trialists' Collaboration: composite endpoint of non-fatal myocardial infarction, non-fatal stroke or vascular death. |
| Key secondary outcome measure(s) |
1. Each component of the primary endpoint |
| Completion date | 27/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20860 |
| Total final enrolment | 21104 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/12/2011 |
| Date of final enrolment | 05/06/2018 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Access to a de-identified participant dataset and data dictionary is available upon reasonable request to researchers who provide a methodologically sound proposal, with no prespecified restrictions on data use. Any such requests should be sent to the corresponding author for consideration by the trial steering committee. There might be restrictions on sharing data derived from record-linkage to NHS datasets. A period of 18 months after publication of the main study results should elapse before requests are made, to allow the authors to publish substudies and further analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/10/2022 | 13/10/2022 | Yes | No | |
| Protocol article | protocol | 09/02/2016 | Yes | No | |
| Protocol article | substudy protocol | 07/06/2018 | Yes | No | |
| Other publications | analysis of recruitment, retention and follow-up rates | 01/12/2017 | 18/03/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | version 1.0 | 11/10/2022 | 13/10/2022 | No | Yes |
| Statistical Analysis Plan | version 1 | 29/06/2022 | 29/07/2022 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 24882 TIME_SAP_v1_29Jun2022.pdf
- Statistical Analysis Plan
- 24882 TIME Full Lay Summary v1.0 11Oct2022.pdf
- Plain English results
Editorial Notes
13/10/2022: The following changes were made to the trial record:
1. The plain English results was uploaded as an additional file.
2. Publication reference added.
3. The recruitment start date was changed from 03/08/2011 to 07/12/2011.
4. The recruitment end date was changed from 04/07/2016 to 05/06/2018.
5. The publication and dissemination plan was updated.
6. The participant level data sharing plan was added.
7. The intention to publish date was changed from 31/12/2022 to 12/10/2022.
29/07/2022: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The overall end date was changed from 30/06/2022 to 27/07/2022.
3. The publication and dissemination plan, was updated.
4. The plain English summary was updated to reflect these changes.
13/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 30/06/2022.
2. The trial website was added.
3. The plain English summary was updated to reflect these changes.
16/04/2020: The following changes have been made:
1. The overall trial end date has been changed from 03/04/2021 to 31/12/2021.
2. The EudraCT number and ClinicalTrials.gov number have been added.
3. The total final enrolment number has been added.
4. The publication and dissemination plan has been added.
5. The intention to publish date has been added.
6. The participant level data statement has been added.
7. The scientific contact has been updated.
8. The plain English summary has been updated to reflect the changes above.
18/03/2020: The following changes have been made:
1. Publication reference added.
2. The overall trial end date has been changed from 31/05/2019 to 03/04/2021.
11/06/2018: Publication reference added.
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.
