Clinical trial NCT02820103: Reducing Acute Coronary Syndrome Patient Delay
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Patient delay
Behaviour change
Intervention Modelling Experiment
Lead sponsor: Edinburgh Napier University
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: University of Aberdeen
name: University of Dundee
name: The University of New South Wales
First posted: 2016-06-30
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Intentions to phone an ambulance immediately in response to scenarios representing possible symptoms of ACS using a 7-point Likert scale.
timeFrame: Immediately post intervention
Secondary outcomes:
measure: Illness and symptom perceptions measured using the brief Illness Perception Questionnaire
timeFrame: Immediately post intervention
measure: Cognitive determinants of intention assessed using questionnaire based upon the theory of planned behaviour.
timeFrame: Immediately post intervention
measure: Self-efficacy assessed using questionnaire based upon Social Cognitive theory
timeFrame: Immediately post intervention
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside
state: Tayside
Study officials:
References:
citation: Farquharson B, Dombrowski S, Pollock A, Johnston M, Treweek S, Williams B, Smith K, Dougall N, Jones C, Pringle S. Reducing patient delay with symptoms of acute coronary syndrome: a research protocol for a systematic review of previous interventions to investigate which behaviour change techniques are associated with effective interventions. Open Heart. 2014 Aug 12;1(1):e000079. doi: 10.1136/openhrt-2014-000079. eCollection 2014.
citation: Farquharson B, Johnston M, Smith K, Williams B, Treweek S, Dombrowski SU, Dougall N, Abhyankar P, Grindle M. Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention. J Adv Nurs. 2017 May;73(5):1220-1234. doi: 10.1111/jan.13191. Epub 2016 Nov 18.