Condition category
Circulatory System
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
30/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

GP practices

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

Mean change in systolic blood pressure after 3 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2011

Overall trial end date

30/09/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial participating centre

Primary Medical Care
University of Southampton Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Trial participating centre

Park & St Francis Surgery
SO53 4ST

Trial participating centre

The Clanfield Practice
PO8 0QL

Trial participating centre

Cowplain Family Practice
PO8 8DL

Trial participating centre

The Oaklands Practice
GU46 7LS

Trial participating centre

Rowlands Castle
PO9 6BN

Trial participating centre

Nightingale Surgery
SO51 7QN

Trial participating centre

Woolston Lodge
SO19 9AL

Trial participating centre

Regents Park Surgery
SO15 3UA

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Research Governance Office
Highfield
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

http://www.soton.ac.uk/

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.

IPD sharing statement
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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

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.