None listed
Conditions
Brief summary
This is a collaborative study designed and co-ordinated jointly by independent investigators at the National Institute for Health Innovation (University of Auckland), and cardiology departments at Auckland and Waitemata District Health Boards. Objectives: To determine the effectiveness of a comprehensive text message, comprehensive, self-management intervention (Text4Heart) for people with ACS, with the following objectives. 1. Enable improved self-management as measured by improvements in 1) medication adherence and 2) adherence to lifestyle risk factors. 2. To provide information for the DHB Funding team to inform a potential roll-out of the programme, including the optimal components of the programme and methods for scaling up and integrating into existing clinical pathways, health IT systems, and an improved model for integrated care for people with heart disease. Duration of treatment: 24 weeks Study design and methodology: A standard, two-arm parallel, randomised controlled trial. Participants will be randomised at a 1:1 ratio to either the Text4Health intervention group or to a usual care ‘control’ group. Those randomised to the Text4Heart self-management programme will receive a personalised automated package of text messages via mobile phone to increase, and maintain positive lifestyle changes, including stopping smoking, eating a heart healthy diet, engaging in regular exercise behaviour, and decreasing stress. The programme will be delivered over 24 weeks. The remaining participants will be directed to receive usual care, which currently involves encouragement to be physically active and an offer to attend cardiac rehabilitation. Outcomes will be assessed at baseline and 24 weeks. Study population: Clinically stable patients diagnosed with an Acute Coronary Syndrome (ACS), which includes myocardial infarction, unstable angina, or patients who have had a percutaneous coronary revascularisation procedure. Number of subjects; A total of 330 participants (165 per group) will be randomised. Eligible participants will be patients with ACS (including those having had a percutaneous coronary revascularisation procedure), who are clinically stable. Previous studies have shown this cohort is able to meet these criteria. Exclusion criteria: Untreated ventricular tachycardia, severe heart failure, life threatening co-existing disease with life expectancy < 1 year, and significant exercise limitations other than CVD. All participants will receive usual CVD support. The primary outcome is the proportion of participants adhering to medication at 24 weeks. The medication adherence measure in this trial will be prescription record-assessed adherence. Seconray outcomes assess self-report adherence to lifestyle change, medication adherence, cost-effectiveness and implementation outcomes.
Interventions
Text4Heart is a self-management programme involving a personalised automated package of text messages via mobile phone to increase, and maintain positive lifestyle changes, including stopping smoking, eating a heart healthy diet, engaging in regular exercise behaviour, and decreasing stress. The programme will be delivered over 24 weeks. Messages focus on providing particpants with key behaviour change strategies to initiate and maintain the respective behaviours. Additional features include pr
Text4Heart is a self-management programme involving a personalised automated package of text messages via mobile phone to increase, and maintain positive lifestyle changes, including stopping smoking, eating a heart healthy diet, engaging in regular exercise behaviour, and decreasing stress. The programme will be delivered over 24 weeks. Messages focus on providing particpants with key behaviour change strategies to initiate and maintain the respective behaviours. Additional features include prompting and support to undertake the behaviour. Intervention messages were developed according to New Zealand clinical guidelines for the management of coronary heart disease, and are based on Social Cognitive Theory principles. Each participant in the intervention group will receive at minimum the basic heart health CR program, consisting of 5 messages per week for 6 months. The general heart health messages provide overall advice and support on undertaking lifestyle change, including, taking medication, being physically active, eating healthy, and reducing alcohol consumption. One message per week on each topic is delivered or the entire six months. Messages are sent to participants at times that suit them and will be personalised to participant’s name (or nickname, and their sex). Participants can also choose their preferred time for receiving messages. The intervention will be predominantly unidirectional; however if participants choose to text questions to the team, these will be answered within 24 hours. Participants will be instructed that the messages are for general heart health issues and that all emergency issues should be managed as per normal procedures. All participants will be offered brief training at enrolment on how to read a text message and how to delete or save messages. Participants will be able to request additional text messages based on the suboptimal behaviour (see below) they wish to modify (identified at their baseline assessment). 1. How to start and maintain a regular exercise program 2. How to start and maintain a heart healthy diet 3. How to reduce stress and increase relaxation 4. How to stop smoking These modules involve 1-2 additional messages per week for 12-weeks. After 12 weeks, participants can choose an new module for the remaining 12-weeks. Each message is sent once. Using the gateway company we will monitor the number of mesages sent and received. Particpants in the intervention group will also complete questions on adherence to the intervention (number of messages recevied and read). The intervention is completely automated and no person delivers the intervention. However. all intervention content was developed by specialists in their respective fields with more than 5 years of experience each (including cardiology, nursing, exercise/physical activity, diet, psychology, smoking cessation). Apart from the messages, no intervention materials are provided to participants.
Sponsors
Ralph Maddison
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
A documented diagnosis of an acute coronary syndrome (including myocardial infarction [MI], unstable angina) or percutaneous coronary revascularisation procedure, are 18 years or older, eligible for cardiac rehabilitation.
Exclusion criteria
Untreated ventricular tachycardia, severe heart failure, life threatening co-existing disease with life expectancy < 1 year, and significant exercise limitations other than cardiovascular disease.
Outcome results
None listed