ISRCTN ISRCTN74757601
DOI https://doi.org/10.1186/ISRCTN74757601
Secondary identifying numbers V2
Submission date
30/04/2013
Registration date
04/07/2013
Last edited
30/07/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr David Wald
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleINvestigation of TExt message Reminders on Adherence to Cardiac Treatment
Study acronymINTERACT
Study objectivesTo determine whether programmed text message reminders improve adherence to cardiovascular disease preventive medication.
Ethics approval(s)East London Research Ethics Committee 1, 28/01/2011, ref: 11/H0703/1
Health condition(s) or problem(s) studiedCardiovascular disease
InterventionText messages for one year or standard care
Intervention typeOther
Primary outcome measureSelf-reported adherence assessed after 6 months and after 18 months
Secondary outcome measures1. Blood pressure
2. Blood cholesterol
3. Health economic analysis
Overall study start date01/04/2012
Completion date01/09/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Key inclusion criteriaAny patient prescribed a blood pressure or cholesterol lowering medication and who owns a mobile phone.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2012
Date of final enrolment01/09/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Joint R&D Office
5 Walden Street
London
E1 2EF
England
United Kingdom

Email gerry.leonard@bartshealth.co.uk
Website http://www.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Research organisation

Queen Mary Innovation Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/12/2014 Yes No