Condition category
Circulatory System
Date applied
17/07/2014
Date assigned
17/07/2014
Last edited
01/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Self-monitoring of blood pressure in hypertension (high blood pressure) is associated with lower blood pressure (BP). However, the evidence for the use of self-monitoring to adjust blood pressure medication by doctors is variable depending which study one looks at. Furthermore, there is some evidence for the effectiveness of telemonitoring (where blood pressure readings are sent electronically) in the management of hypertension, but it is not clear what this adds over and above self-monitoring. This study aims to evaluate whether GP-led adjustment of blood pressure measurement using self-monitoring results in lower systolic BP compared to usual care (using clinic blood pressure readings), and whether telemonitoring adds anything to self-monitoring alone.

Who can participate?
Patients aged 35 or over with poorly controlled hypertension

What does the study involve?
Participants are randomly allocated to either usual care, self-monitoring alone (measuring your own blood pressure and sharing results with GP using a paper record sheet), or self-monitoring with telemonitoring (measuring your own blood pressure, sending the results electronically to your GP). There are follow-up clinics after 6 and 12 months. We also look at whether self-monitoring affects things like how well people take their medication, smoking, diet and exercise, quality of life, adverse events and costs. We talk to a sample of participants about their experiences of the study.

What are the possible risks and benefits of taking part?
The main benefits are likely to be after the study has finished in terms of doctors knowing whether self-monitoring of blood pressure is worthwhile. It is not anticipated that there will be any particular risks in taking part over and above those associated with normal blood pressure treatment. Those who self-monitor will need to spend extra time doing this and blood pressure cuffs can occasionally be uncomfortable. Everyone taking part will be asked to attend three clinics (start, middle and end) which will take around an hour each.

Where is the study run from?
Nuffield Department of Primary Care Health Sciences (UK)

When is the study starting and how long is it expected to run for?
September 2014 to March 2017

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

Who is the main contact?
Prof. Richard McManus
richard.mcmanus@phc.ox.ac.uk

Trial website

http://www.phc.ox.ac.uk/research/hypertension/monitoring-and-self-monitoring/tasminh4

Contact information

Type

Scientific

Primary contact

Prof Richard McManus

ORCID ID

http://orcid.org/0000-0003-3638-028X

Contact details

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
-
richard.mcmanus@phc.ox.ac.uk

Type

Public

Additional contact

Ms Marloes Franssen

ORCID ID

Contact details

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
-
marloes.franssen@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16745

Study information

Scientific title

Telemonitoring and/or self-monitoring in hypertension (TASMINH4): a randomised controlled trial

Acronym

TASMINH4

Study hypothesis

The aim of this study is to evaluate the management of hypertension in primary care using self-monitored blood pressure, with or without telemonitoring compared to standard care. The study also aims to address:
1. Is self-monitoring acceptable to patients and cost-effective?
2. Does self-monitoring affect antihypertensive medication adherence?
3. Does self-monitoring affect lifestyle factors including smoking, alcohol, diet and exercise?
4. Is it possible to use routine GP clinical systems to collect sufficiently robust data for a subsequent trial powered on cardiovascular outcomes?

Ethics approval

14/SC/0218; First MREC approval date 25/06/2014

Study design

Randomised; Interventional; Design type: Prevention, Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hypertension

Intervention

Current interventions as of 27/05/2016:
370 patients will be randomised to usual care (UC) and 740 randomised to self-monitoring (370 self-monitoring alone and 370 telemonitoring).

1. Self-monitoring alone: Patients in the self-monitoring alone group will be asked to monitor their blood pressure twice each morning and evening (i.e. four times in all) for the first week of each month. A paper record sheet will be used for communication between patient and health care professionals in the self-monitoring alone group. GPs and nurses will be advised to calculate the mean self-monitored blood pressure and to use this to titrate antihypertensive medication.

2. Telemonitoring: the frequency of self-monitoring will be identical to the self-monitoring alone group but blood pressure readings will be transmitted to a secure centralised database from which the GP/ nurse can review the records. Readings will be transmitted by free SMS text message. A mean blood pressure will be automatically calculated. High or low readings will trigger alerts to patient to contact their surgery for a blood pressure check. GPs and nurses will be advised to use the mean self-monitored blood pressure to titrate antihypertensive medication.

3. Usual Care: Management for the control group will be usual care guided by office BP measured by the GP/practice nurse without further instruction.

Previous interventions:
370 patients are randomised to usual care (UC) and 740 randomised to self-monitoring arm.

1. Telemonitoring: Patients in the self-monitoring arms will be asked to monitor their blood pressure twice each morning and evening (i.e. four times in all). Patients will self-monitor for the first week of each month. Frequency identical to self-monitoring but readings transmitted to a secure centralised database from which GP/ nurse can review the records. Readings will be transmitted by free SMS text message. In the telemonitoring group, a mean blood pressure will be automatically calculated. High or low readings will trigger alerts to patient to contact their surgery for a blood pressure check. A paper record sheet will be used for communication in the self-monitoring alone group. Nurses will follow an algorithm that recommends adjustment of antihypertensive medication on the basis of the number of readings above target: if more than half are above target then the algorithm will reco

2. Usual Care: Management for the control group will be usual care guided by office BP measured by the
GP/practice nurse without further instruction.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Systolic BP (mean of 2nd and 3rd BP readings); Timepoint(s): 12 months

Secondary outcome measures

Current secondary outcome measures as of 01/06/2016:
1. Systolic and diastolic BP; Timepoint(s): 6 months and 12 months
2. Costs, health sector resource use, and acceptability; Timepoint(s): 12 months
3. MARS adherence questionnaires and prescribing data; Timepoint(s): 12 months
4. Questionnaire data on lifestyle factors; Timepoint(s): 12 months
5. Comparison between trial outcome data and that from clinical databases; Timepoint(s): 12 months

Previous secondary outcome measures:
1. Systolic and diastolic BP; Timepoint(s): 6 months and 12 months
2. Costs, health sector resource use, and acceptability; Timepoint(s): 24 months
3. MARS adherence questionnaires and prescribing data; Timepoint(s): 12 months
4. Questionnaire data on lifestyle factors; Timepoint(s): 12 months
5. Comparison between trial outcome data and that from clinical databases; Timepoint(s): 24 months

Overall trial start date

01/09/2014

Overall trial end date

28/03/2017

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 35 years or above
3. On practice hypertension register, not already taking more than 3 anti-hypertensive agents and above clinic target BP (i.e. =140/90 mmHg) at baseline (mean of 2nd/ 3rd readings)
4. Stable dose of current antihypertensive medication for at least four weeks prior to trial entry
5. In the Investigator’s opinion, is able and willing to comply with all trial requirements or has a carer able to help sufficiently (e.g. in the case of physical issues with self-monitoring)
6. Willing to allow his or her General Practitioner to be notified of participation in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1110; UK Sample Size: 1110

Participant exclusion criteria

1. BP below target at baseline (i.e. <140/90 mmHg on clinic measurement at baseline visit).
2. Already taking more than 3 anti-hypertensive agents.
3. Orthostatic hypotension: more than 20mmHg systolic drop after standing for 1 minute.
4. Diagnosed atrial fibrillation.
5. Unwilling to self-monitor.
6. BP managed outside of primary care (including secondary hypertension).
7. Unable to provide consent.
8. Dementia or score over 10 on the short orientation memory concentration test (and with no carer support),
9. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
10. The partner or spouse of an individual already randomised in the trial
11. Chronic Kidney Disease (CKD) Grade 4 or worse; any grade of CKD with proteinuria.
12. 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).
13. Participants who have participated in another research trial involving an antihypertensive medication in the past 4 weeks.

Recruitment start date

13/11/2014

Recruitment end date

03/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom

Trial participating centre

144 practices recruited from the following NIHR Clinical Research Networks:
Thames Valley, West Midlands, East of England, West of England, Kent Surrey and Sussex, North West Coast, North West London
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United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research; Grant Codes: RP-PG-1209-10051

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

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/05/2016: overall trial end date was changed from 31/08/2015 to 28/03/2017.