Self Measurement and management using the Internet for Lowering blood pressure in Everyday practice (SMILE study)
| ISRCTN | ISRCTN70714356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70714356 |
| Protocol serial number | 10176 |
| Sponsor | University of Southampton (UK) |
| Funder | NIHR National School of Primary Care Research; Grant Codes: 4.74 |
- Submission date
- 10/08/2011
- Registration date
- 10/08/2011
- Last edited
- 30/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study addresses overlapping issues in patient engagement: a patient support tool to implement a lifestyle intervention that practice nurses currently do not have the time and expertise to implement, and home blood pressure measurements with self-titration (dose adjustment) of medication for lowering blood pressure.
Who can participate?
Patients aged over 18 with high blood pressure
What does the study involve?
The study involves two phases. In Phase 1 the LifeGuide web tool, diet materials, and web pages used in an obesity web intervention (on diet and exercise) are used as the basis for writing the initial web pages for the web intervention. Focus groups and 1:1 interviews with patients and nurses are used to modify the site. In Phase 2 patients are randomly allocated to one of three groups. The first group receive usual care (normal clinic measurement by a GP or nurse). The second group use home blood pressure measurement with telemonitoring. The third group use home blood pressure measurement with telemonitoring and receive access to the lifestyle website with reinforcement by the practice nurse over a 3-month period. After 3 months the changes in blood pressure in the three groups are compared.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
September 2011 to September 2012
Who is funding the study?
NIHR National School of Primary Care Research (UK)
Who is the main contact?
Prof. Paul Little
Contact information
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0003-3664-1873 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional prevention process of care trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Self Measurement and management using the Internet for Lowering blood pressure in Everyday practice: a randomised controlled trial |
| Study acronym | SMILE |
| Study objectives | This study addresses overlapping issues in patient engagement: 1. A patient support tool to implement lifestyle intervention (the effective and acceptable DASH diet and exercise) that practice nurses currently do not have the time and expertise to implement 2. Home blood pressure measurements with self titration of medication It involves two distinct phases, the initial development of a web intervention followed by a randomised controlled trial to explore the extent to which the interventions can change. |
| Ethics approval(s) | First MREC, 29/03/2011, ref: 11/SC/0051 |
| Health condition(s) or problem(s) studied | Essential hypertension |
| Intervention | Current interventions as of 30/11/2017: 1. Phases: 1.1. Phase 1 patient Interviews: 16 + 3 healthcare professionals 1.2. Phase 1 focus groups: 8 healthcare professionals 1.3. Phase 2 RCT: 50, randomised into 3 groups 2. At baseline, weight and blood pressure measured 3. End of study, weight and blood pressure measured within GP surgery 4. Home measurement, self monitoring of blood pressure by patients 5. Follow up after 12 months 6. Study entry: registration and one or more randomisations Previous interventions: 1. Phases: 1.1. Phase 1 patient Interviews: 30 1.2. Phase 1 focus groups: 35 1.3. Phase 2 RCT: 90, randomised into 3 groups 2. At baseline, weight and blood pressure measured 3. End of study, weight and blood pressure measured within GP surgery 4. Home measurement, self monitoring of blood pressure by patients 5. Follow up after 12 months 6. Study entry: registration and one or more randomisations |
| Intervention type | Other |
| Primary outcome measure(s) |
Mean change in systolic blood pressure after 3 months |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 155 |
| Key inclusion criteria | 1. Over 18 years 2. Treated essential hypertension 3. Poor control blood pressure greater than 140/90 mmHg and less than 200/110 mmHg 3. Home access to the internet 4. Access to a telephone line |
| Key exclusion criteria | 1. Inability to self monitor (including diagnosis of of dementia, score of >10 on short orientation memory concentration test) 2. Postural hypertension (systolic blood pressure drop >20mmHg) 3. More than two antihypertensive medications 4. Terminal disease 5. Hypertension not managed by family doctor 6. Spouse already randomised to the study group |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the fact that this was preliminary pilot work. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/11/2017: Contact, sponsor address, trial participating centres and interventions updated, condition category, plain English summary, publication and dissemination plan and IPD sharing statement added.
