Condition category
Not Applicable
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
18/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Susan Broomfield

ORCID ID

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

All Diseases

Intervention

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; Description:

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

Aldermoor Health Centre
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes