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
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 |
---|---|
R.J.McManus@Bham.ac.uk |
Study information
Study design | Primary-care based unblinded randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised controlled trial of telemonitoring and self management in the control of hypertension: Telemonitoring And Self Management IN Hypertension |
Study acronym | TASMINH2 |
Study objectives | 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(s) | Sandwell and West Birmingham Local Research Ethics Committee, 10/10/2005, ref: 05/Q2709/103 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/11/2006 |
Completion date | 01/10/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 478; 239 per group |
Key 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) |
Key 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) |
Date of first enrolment | 01/11/2006 |
Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Website | http://www.bham.ac.uk |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.