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Clinical Trials/NCT02820103
NCT02820103UnknownNot Applicable

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

Edinburgh Napier University2 sites in 1 country177 target enrollmentStarted: February 20, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
177
Locations
2
Primary Endpoint
Intentions to phone an ambulance immediately in response to scenarios representing possible symptoms of ACS using a 7-point Likert scale.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Information leaflet (control)

Active Comparator

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. The information from two leaflets: 1. 'Using GTN', produced by the hospital and 'Angina' produced by the British Heart Foundation, published 08/04/2014 and available at https://www.bhf.org.uk/publications/heart-conditions/angina . The information explains the symptoms of angina and heart attack and advises what to do in the event of experiencing these symptoms. This information will be presented in written text format on screen.

Intervention: Leaflet information (control) (Behavioral)

Text+Visual BCT-based intervention (Intervention Group 1)

Experimental

Participants in the visual intervention group will receive the control condition specified above PLUS a specifically developed Text+Visual BCT-based intervention, comprising the 12 BCTs identified earlier in a Systematic Review and expert consensus study. The BCTs are Problem solving; Action planning; Social support (practical); Social support (emotional); Instruction on how to perform the behaviour; Information about health consequences; Salience of health consequences; Prompts/cues; Credible source; Pro's & Con's; Comparative imagining of future outcomes; Mental rehearsal of successful performance

Intervention: Text+Visual BCT-based intervention (Behavioral)

Text+Visual BCT-based intervention (Intervention Group 1)

Experimental

Participants in the visual intervention group will receive the control condition specified above PLUS a specifically developed Text+Visual BCT-based intervention, comprising the 12 BCTs identified earlier in a Systematic Review and expert consensus study. The BCTs are Problem solving; Action planning; Social support (practical); Social support (emotional); Instruction on how to perform the behaviour; Information about health consequences; Salience of health consequences; Prompts/cues; Credible source; Pro's & Con's; Comparative imagining of future outcomes; Mental rehearsal of successful performance

Intervention: Leaflet information (control) (Behavioral)

Text-only BCT-based intervention (Intervention Group 2)

Experimental

Information leaflet (usual care) plus text-only BCT-based intervention (Intervention group 2) Participants in the text-only BCT-based intervention group will receive the control condition 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 instead.

Intervention: Text-only BCT intervention (Behavioral)

Text-only BCT-based intervention (Intervention Group 2)

Experimental

Information leaflet (usual care) plus text-only BCT-based intervention (Intervention group 2) Participants in the text-only BCT-based intervention group will receive the control condition 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 instead.

Intervention: Leaflet information (control) (Behavioral)

Outcomes

Primary Outcomes

Intentions to phone an ambulance immediately in response to scenarios representing possible symptoms of ACS using a 7-point Likert scale.

Time Frame: 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 Outcomes

  • Illness and symptom perceptions measured using the brief Illness Perception Questionnaire(Immediately post intervention)
  • Cognitive determinants of intention assessed using questionnaire based upon the theory of planned behaviour.(Immediately post intervention)
  • Self-efficacy assessed using questionnaire based upon Social Cognitive theory(Immediately post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Barbara Farquharson

Dr Barbara Farquharson

Edinburgh Napier University

Study Sites (2)

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