Reducing Acute Coronary Syndrome Patient Delay

Not Applicable

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02820103
• Lead Sponsor: Edinburgh Napier University

Brief 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).

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Study Start: 2017-02-20
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Adults, aged > 18 years
• Experience of Acute Coronary Syndrome within the previous six months

Exclusion Criteria

• Anyone still hospitalised
• People who have experienced ACS within the previous two weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intentions to phone an ambulance immediately in response to scenarios representing possible symptoms of ACS using a 7-point Likert scale.	Immediately post intervention	Intention: Informed by the Theory of Planned Behaviour (Ajzen 1991), participants' intentions to phone an ambulance immediately will be assessed in response to each scenario using a single Likert-type item ('For these symptoms, after this amount of time, I would phone an ambulance immediately') scored 1=strongly disagree to 7=strongly agree.

Secondary Outcome Measures

Name	Time	Method
Illness and symptom perceptions measured using the brief Illness Perception Questionnaire	Immediately post intervention	Participants' illness representations in relation to symptoms presented in each scenario will be assessed using the Brief Illness Perception Questionnaire (B-IPQ) (Broadbent et al. 2006). The questionnaire consists of 9 items assessing the five components that make up a person's perception of their illness - identity (beliefs about the illness label and symptoms), cause (beliefs about factors responsible for causing illness), timeline (beliefs and expectations about the course of illness), consequences (beliefs and expectations about the impact of illness) and cure-control (beliefs about the efficacy of treatment or coping behaviours). The questionnaire has good test-retest reliability, has been validated among people with Myocardial Infarction (MI) and has been shown able to distinguish between different illnesses (Broadbent et al. 2006).
Cognitive determinants of intention assessed using questionnaire based upon the theory of planned behaviour.	Immediately post intervention	: Informed by the Theory of Planned Behaviour (Ajzen 1991), the questionnaire will include - three items assessing attitude toward phoning an ambulance immediately using semantic differential scales (e.g. Useless-Useful) scored 1 to 7; three subjective norm items (e.g. people who are important to me think I should phone ambulance immediately in this situation) scored 1=Strongly disagree to 7=Strongly agree; and three perceived behavioural control items (e.g. Phoning an ambulance immediately in this situation is beyond my control) scored 1=Strongly disagree to 7=Strongly agree.
Self-efficacy assessed using questionnaire based upon Social Cognitive theory	Immediately post intervention	Informed by the Social Cognitive Model (Bandura 1998), people's generic self-efficacy to call an ambulance immediately will be assessed once before and once after the intervention. Participants will be asked to rate how certain they are that they could phone an ambulance immediately in nine different situations which vary in how difficult it would be to phone an ambulance (e.g. if you were out with friends). Responses will be elicited on a scale ranging from 0=not at all certain to 100=highly certain.

Trial Locations

Locations (1)

NHS Tayside; 🇬🇧 Dundee, Tayside, United Kingdom