Condition category
Circulatory System
Date applied
30/04/2013
Date assigned
04/07/2013
Last edited
30/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Two facts regarding cardiovascular diseases are well established. First, that lowering blood pressure and cholesterol can reduce the risk of heart attacks and strokes to a great extent. Second, about half of all patients prescribed medication discontinue them after about 2 years. This leads to many thousands of avoidable deaths from cardiovascular disease and a significant economic health burden.
An important research question is how adherence to treatment (continuing with prescribed treatment) can be improved in a simple, acceptable and cost-effective way. This study aims to determine the extent to which text message reminders improve adherence to medication.

Who can participate?
Anyone with a mobile phone who has been prescribed cholesterol-lowering or blood pressure lowering treatment for the prevention of cardiovascular disease.

What does the study involve?
Participants are randomly allocated to receiving a programme of text messages or standard care. Participants allocated to text messages receive these for one year. Adherence to the starting medication is assessed after 6 months and after 18 months, using a questionnaire and measurements of blood pressure and blood cholesterol.

What are the possible benefits and risks of participating?
An improvement in medication adherence.

Where is the study run from?
The Wolfson Institute of Preventive Medicine and local London General Practices.

When is the study starting and how long is it expected to run for?
Started in 2012 and lasting until 18 months after the last patient is recruited.

Who is funding the study?
Queen Mary University of London

Who is the main contact?
Dr David Wald
Wolfson Institute of Preventive Medicine, London

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Wald

ORCID ID

Contact details

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2

Study information

Scientific title

INvestigation of TExt message Reminders on Adherence to Cardiac Treatment

Acronym

INTERACT

Study hypothesis

To determine whether programmed text message reminders improve adherence to cardiovascular disease preventive medication.

Ethics approval

East London Research Ethics Committee 1, 28/01/2011, ref: 11/H0703/1

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular disease

Intervention

Text messages for one year or standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Self-reported adherence assessed after 6 months and after 18 months

Secondary outcome measures

1. Blood pressure
2. Blood cholesterol
3. Health economic analysis

Overall trial start date

01/04/2012

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient prescribed a blood pressure or cholesterol lowering medication and who owns a mobile phone.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2012

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Joint R&D Office
5 Walden Street
London
E1 2EF
United Kingdom
-
gerry.leonard@bartshealth.co.uk

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Research organisation

Funder name

Queen Mary Innovation Fund (UK)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25479285

Publication citations

Additional files

Editorial Notes