Telemonitoring and/or self-monitoring in hypertension
| ISRCTN | ISRCTN83571366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83571366 |
| Secondary identifying numbers | 16745 |
- Submission date
- 17/07/2014
- Registration date
- 17/07/2014
- Last edited
- 13/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Scientific
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0003-3638-028X |
|---|---|
| richard.mcmanus@phc.ox.ac.uk |
Public
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| marloes.franssen@phc.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention, Process of Care, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Telemonitoring and/or self-monitoring in hypertension (TASMINH4): a randomised controlled trial |
| Study 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(s) | First MREC approval date 25/06/2014, ref: 14/SC/0218 |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2014 |
| Overall study end date | 28/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1110; UK Sample Size: 1110 |
| 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 Investigators' 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 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 participants 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
- England
- United Kingdom
Study participating centres
OX2 6GG
United Kingdom
-
United Kingdom
Sponsor information
University/education
Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 13/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Two further publications from this trial are planned before the end of 2018, a qualitative paper and a health economics paper. Publications analysing the secondary outcomes are also planned within the next 5 years. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/02/2017 | Yes | No | |
| Results article | results | 10/03/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/04/2018: Publication and dissemination plan added.
08/03/2018: Publication reference added.
14/02/2017: Publication reference added.
27/05/2016: The overall trial end date was changed from 31/08/2015 to 28/03/2017.
