Condition category
Circulatory System
Date applied
06/10/2006
Date assigned
10/11/2006
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard McManus

ORCID ID

Contact details

Department of Primary Care and General Practice
Primary Care and Clinical Sciences Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4142658
R.J.McManus@Bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2 26/06/2006

Study information

Scientific title

A randomised controlled trial of telemonitoring and self management in the control of hypertension: Telemonitoring And Self Management IN Hypertension

Acronym

TASMINH2

Study hypothesis

The primary aim of TASMINH2 is to compare self management with usual care in the control of hypertension. The trial has three main research questions:
1. Does self management with telemonitoring and titration of antihypertensive medication by people with poorly controlled hypertension result in better control of blood pressure?
2. Does self management with telemonitoring and titration of antihypertensive medication by people with poorly controlled hypertension result in changes in reported adverse events or health behaviours and is it cost effective?
3. Is self management with telemonitoring and titration of antihypertensive medication achievable in routine practice and is it acceptable to patients?

Ethics approval

Sandwell and West Birmingham Local Research Ethics Committee, 10/10/2005, ref: 05/Q2709/103

Study design

Primary-care based unblinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Uncontrolled treated hypertension

Intervention

TASMINH2 is a primary-care based, unblinded, randomised controlled trial with embedded economic and qualitative analyses in order to evaluate the costs and effects of increasing patient involvement in blood pressure management. Randomisation of patients with uncontrolled hypertension will be to either usual care or self management of their hypertension and will take place centrally using the process of minimisation taking into account practice, sex, diabetic status, baseline blood pressure and age.

Usual care will consist of the participant seeing their GP and/or nurse periodically for blood pressure measurement and/or adjustment of medication at the discretion of the GP.

Self management will consist of self monitoring of blood pressure with electronic transmission of readings, and self titration of medication dependant on the self monitoring readings.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Mean change in systolic blood pressure (mmHg) between baseline and each follow up point (six months and 12 months), measured in the surgery by the research team.

Secondary outcome measures

1. Adverse events (side effects, anxiety)
2. Health behaviours
3. Patient satisfaction
4. Costs and reasons for non-participation

Overall trial start date

01/11/2006

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 35 and 75
2. Treated hypertension
3. Blood pressure greater or equal to 140/90 (140/80 mmHg for those with diabetes)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

478; 239 per group

Participant exclusion criteria

1. Inability to self monitor
2. More than three antihypertensive medications
3. Terminal disease
4. Blood pressure not managed by their General Practitioner (GP)

Recruitment start date

01/11/2006

Recruitment end date

01/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk

Funders

Funder type

Government

Funder name

NHS executive, Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19220913
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20619448
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25566874

Publication citations

  1. Protocol

    McManus RJ, Bray EP, Mant J, Holder R, Greenfield S, Bryan S, Jones MI, Little P, Williams B, Hobbs FD, Protocol for a randomised controlled trial of telemonitoring and self-management in the control of hypertension: telemonitoring and self-management in hypertension. [ISRCTN17585681]., BMC Cardiovasc Disord, 2009, 9, 6, doi: 10.1186/1471-2261-9-6.

  2. Results

    McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FD, Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial., Lancet, 2010, 376, 9736, 163-172, doi: 10.1016/S0140-6736(10)60964-6.

  3. Results

    Bray EP, Jones MI, Banting M, Greenfield S, Hobbs FD, Little P, Williams B, Mcmanus RJ, Performance and persistence of a blood pressure self-management intervention: telemonitoring and self-management in hypertension (TASMINH2) trial, J Hum Hypertens, 2015 , 29, 7, 436-441, doi: 10.1038/jhh.2014.108.

Additional files

Editorial Notes

05/05/2016: Publication reference added.