Acute Coronary Syndrome Clinical Trial
Official title:
Reducing Patient Delay in Acute Coronary Syndrome (RAPiD): A Web-based Randomised Controlled Trial Examining the Effect of a Behaviour Change Intervention on Participants' Intentions to Seek Help
1. To test the effectiveness of the theory-based interventions (text+visual and text-only
BCT-based interventions) against usual care in changing patients' intentions to phone
ambulance immediately with symptoms of ACS ≥ 15 minutes duration.
2. To determine the most effective mode of delivery by comparing the text+visual BCT-based
intervention with text-only BCT-based intervention.
3. To investigate any unintended consequences of the intervention on intentions to phone an
ambulance for non-life-threatening symptoms.
Patient delay means many people do not achieve optimal benefit of time-dependent treatments
for Acute Coronary Syndrome (ACS). Reducing delay would reduce mortality and morbidity but to
date, interventions to change behaviour have had mixed results. Systematic inclusion of
behaviour-change techniques (BCTs) or a visual mode of delivery might improve the efficacy of
interventions.
Aim To evaluate the efficacy of a BCT-based intervention and to compare two possible modes of
delivery (text+visual and text-only).
Design A 3-arm web-based, parallel randomised, controlled trial of a theory-based
intervention.
Methods and analysis The intervention comprises 12 BCTs systematically identified following
systematic review and a consensus exercise undertaken with behaviour change experts. We aim
to recruit n=177 participants who have experienced ACS in the previous 6 months from a local
National Health Service (NHS) Teaching Hospital. Participants will be identified by Cardiac
Rehabilitation staff and invited by letter to take part in the study. Those who wish to take
part will be asked to access the experiment at a secure web-address and consent re-checked.
Consenting participants will be randomly allocated in equal numbers to one of three study
groups: i) usual care ii) usual care plus text-only BCT-based intervention or iii) usual care
plus text+visual BCT-based intervention. The outcome variable will be the change in intention
to phone an ambulance immediately with symptoms of ACS ≥15 minutes duration assessed using
two randomised series of 8 scenarios representing varied symptoms before and after delivery
of the interventions or control condition (usual care).
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