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
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
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