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

ISRCTN ISRCTN17585681
DOI https://doi.org/10.1186/ISRCTN17585681
Secondary identifying numbers V2 26/06/2006
Submission date
06/10/2006
Registration date
10/11/2006
Last edited
05/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard McManus
Scientific

Department of Primary Care and General Practice
Primary Care and Clinical Sciences Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)121 4142658
Email R.J.McManus@Bham.ac.uk

Study information

Study designPrimary-care based unblinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial of telemonitoring and self management in the control of hypertension: Telemonitoring And Self Management IN Hypertension
Study acronymTASMINH2
Study objectivesThe 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(s)Sandwell and West Birmingham Local Research Ethics Committee, 10/10/2005, ref: 05/Q2709/103
Health condition(s) or problem(s) studiedUncontrolled treated hypertension
InterventionTASMINH2 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 typeOther
Primary outcome measureMean 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 measures1. Adverse events (side effects, anxiety)
2. Health behaviours
3. Patient satisfaction
4. Costs and reasons for non-participation
Overall study start date01/11/2006
Completion date01/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants478; 239 per group
Key inclusion criteria1. Aged between 35 and 75
2. Treated hypertension
3. Blood pressure greater or equal to 140/90 (140/80 mmHg for those with diabetes)
Key exclusion criteria1. Inability to self monitor
2. More than three antihypertensive medications
3. Terminal disease
4. Blood pressure not managed by their General Practitioner (GP)
Date of first enrolment01/11/2006
Date of final enrolment01/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website http://www.bham.ac.uk
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Government

NHS executive, Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 16/02/2009 Yes No
Results article results 17/07/2010 Yes No
Results article results 01/07/2015 Yes No

Editorial Notes

05/05/2016: Publication reference added.