Reducing Acute Coronary Syndrome Patient Delay
RAPiD
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 other identifier
interventional
177
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
February 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 16, 2017
August 1, 2017
7 months
June 21, 2016
August 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intentions to phone an ambulance immediately in response to scenarios representing possible symptoms of ACS using a 7-point Likert scale.
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.
Immediately post intervention
Secondary Outcomes (3)
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
Study Arms (3)
Information leaflet (control)
ACTIVE COMPARATORParticipants 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.
Text+Visual BCT-based intervention (Intervention Group 1)
EXPERIMENTALParticipants 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
Text-only BCT-based intervention (Intervention Group 2)
EXPERIMENTALInformation 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Adults, aged \> 18 years
- Experience of Acute Coronary Syndrome within the previous six months
You may not qualify if:
- Anyone still hospitalised
- People who have experienced ACS within the previous two weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Edinburgh Napier Universitylead
- University of Stirlingcollaborator
- University of Aberdeencollaborator
- University of Dundeecollaborator
- The University of New South Walescollaborator
Study Sites (1)
NHS Tayside
Dundee, Tayside, DD1 9SY, United Kingdom
Related Publications (3)
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.
PMID: 25332805BACKGROUNDFarquharson B, Johnston M, Williams B, Smith K, Dombrowski S, Jones C, Treweek S, Dougall N, Grindle M, Savinc J, Abyhankar P. Reducing patient delay in acute coronary syndrome: Randomized controlled trial testing effect of behaviour change intervention on intentions to seek help. Br J Health Psychol. 2023 Feb;28(1):188-207. doi: 10.1111/bjhp.12619. Epub 2022 Aug 8.
PMID: 35942523DERIVEDFarquharson 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.
PMID: 27779777DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Barbara Farquharson
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 30, 2016
Study Start
February 20, 2017
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
August 16, 2017
Record last verified: 2017-08