NCT02820103

Reducing Acute Coronary Syndrome Patient Delay

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Edinburgh Napier University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Text+Visual BCT-based intervention	Participants in the visual intervention group will receive usual care specified below plus a specifically developed Text + Visual BCT-based intervention, comprising 12 BCTs identified from SR and expert consensus study. An animated video, just under 8 minutes in length is hosted online in the Intervention Modelling Experiment. The animation contains 9 of the 12 BCTs and tells the 'delay stories' of three different characters. It was not possible to deliver all of the 12 BCTs comprehensively in the relatively passive media of the animation as some techniques require active participation from participants (e.g. action planning). Thus, n=7 BCTs (1 2 Problem-solving; 1 4 Action planning; 5 2 Salience of consequences; 7 1 Prompts/cues; 9 3 Comparative imagining of future outcomes; 15 2 Mental rehearsal of successful performance) are also delivered via short web-based exercises which follow the animation.
BEHAVIORAL	Text-only BCT intervention	Participants in the text-only BCT-based intervention group will receive the usual care specified above plus a text-only BCT-based intervention. This was developed in the same way as the text + visual BCT-based intervention but does not include the visual elements (i.e. animation). Instead, the voiceover from the animated film is displayed in text on screen and narrated in audio. The BCTs which require active engagement are delivered via identical web-based exercises as the text + visual BCT-based intervention.
BEHAVIORAL	Leaflet information (control)	Participants in the control group will receive information that is currently used routinely in the NHS site to inform patients with ACS what to do if they experience symptoms after discharge.

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-06-30
• Last updated: 2017-08-16

Locations

1 site across 1 country: United Kingdom