ACTRN12616000422426.
| Study name | Text4Heart Partnership: a text messaging programme to enhance self‐management of cardiovascular disease. |
| Methods | RCT Participants will be randomised via a central randomisation service accessed by computer at the time of allocation. Blinded (masking used) |
| Participants | A documented diagnosis of an acute coronary syndrome (including myocardial infarction, unstable angina) or percutaneous coronary revascularisation procedure, are 18 years or older, eligible for cardiac rehabilitation. 18 years to 80 years, both men and women. Exclusion: Untreated ventricular tachycardia, severe heart failure, life‐threatening co‐existing disease with life expectancy < 1 year, and significant exercise limitations other than cardiovascular disease. |
| 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 participants 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 messages sent and received. Particpants in the intervention group will also complete questions on adherence to the intervention (number of messages received 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. Participants in the control arm will be offered the standard outpatient CR programme provided by each hospital, which involves support and education provision to discharged patients, with supervised exercise offered at all 3 participating hospitals for those wishing to participate (Phase 2 CR usually of 6 ‐ 12 weeks duration). During Phase 3 participants are encouraged to continue with their lifestyle changes and join a cardiac club. Heart Guide Aotearoa is also offered at the discretion of cardiac nurses. Given the proven effectiveness of CR, it would be unethical not to offer usual CR to all participants; therefore the Intervention arm participants will be advised that they are able to access the usual CR programme in addition to the mHealth intervention, if they wish to do so. |
| Outcomes | PRIMARY OUTCOMES: Proportion of participants adhering to medication at 24 weeks. The medication adherence measure in this trial will be prescription record‐assessed adherence, defined as: a dispensed medication ratio of 80% for each of the classes of medications consistent with guideline recommended therapy (e.g. antiplatelet, statin, and blood pressure‐lowering therapy, ACE‐inhibitor and/or a beta blocker). SECONDARY OUTCOMES:
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| Starting date | 18/04/2016 |
| Contact information | Prof Ralph Maddison National Institute for Health Innovation University of Auckland, Private Bag 92019, Auckland 1142, New Zealand Phone +6421470710 Email r.maddison@auckland.ac.nz |
| Notes | Registered 23/03/2016; ACTRN12616000422426 |