Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Prof Paul Little
ORCID ID
http://orcid.org/0000-0003-3664-1873
Contact details
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
10176
Study information
Scientific title
Self Measurement and management using the Internet for Lowering blood pressure in Everyday practice: a randomised controlled trial
Acronym
SMILE
Study hypothesis
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
Study design
Randomised interventional prevention process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Mean change in systolic blood pressure after 3 months
Secondary outcome measures
No secondary outcome measures
Overall study start date
01/09/2011
Overall study end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned Sample Size: 155; UK Sample Size: 155 - to include both phases
Participant 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
Recruitment start date
01/09/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Primary Medical Care
University of Southampton
Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom
Study participating centre
Park & St Francis Surgery
SO53 4ST
Study participating centre
The Clanfield Practice
PO8 0QL
Study participating centre
Cowplain Family Practice
PO8 8DL
Study participating centre
The Oaklands Practice
GU46 7LS
Study participating centre
Rowlands Castle
PO9 6BN
Study participating centre
Nightingale Surgery
SO51 7QN
Study participating centre
Woolston Lodge
SO19 9AL
Study participating centre
Regents Park Surgery
SO15 3UA
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Research Governance Office
Highfield
Southampton
SO17 1BJ
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
NIHR National School of Primary Care Research; Grant Codes: 4.74
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This was a very small pilot and development study that mainly concentrated on the development of the website, and was used as the basis for arguing for a much larger Programme grant subsequently funded by NIHR PGfAR: the trial from that Programme will be published and the data will be made available.
Intention to publish date
Individual participant data (IPD) Intention to share
No
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.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|