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Acute Coronary SyndromeRAPiDNCT02820103

Reducing Acute Coronary Syndrome Patient Delay

A study testing Text+Visual BCT-based intervention and Text-only BCT intervention in people with Acute Coronary Syndrome, run by Edinburgh Napier University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Text+Visual BCT-based intervention and Text-only BCT intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
1 siteUnited Kingdom
Study dates
20 Feb 2017to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Barbara Farquharson, PhD contact

0131 455 3475

b.farquharson@napier.ac.uk

Brian Williams, PhD contact

brian.williams@stir.ac.uk

United Kingdom1 site, 1 recruiting

  • NHS Tayside

    Dundee, Tayside, DD1 9SY

    Karen Smith, PhD, 01382667421, k.m.smith@dundee.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

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

  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.
Read the 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).

Being tested
Text+Visual BCT-based intervention, Text-only BCT intervention, Leaflet information (control)
Keywords
Patient delay, Behaviour change, Intervention Modelling Experiment
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text+Visual BCT-based interventionBehavioural

    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.

  • Text-only BCT interventionBehavioural

    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.

  • Leaflet information (control)Behavioural

    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.

Study groups in NCT02820103
Study groupRoleWhat they receive
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.
Receives: Behavioral: Leaflet information (control)
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
Receives: Behavioral: Text+Visual BCT-based intervention; Behavioral: Leaflet information (control)
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.
Receives: Behavioral: Text-only BCT intervention; Behavioral: Leaflet information (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately post intervention

Secondary outcomes (3)

  1. Illness and symptom perceptions measured using the brief Illness Perception Questionnaire

    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).

    Measured: Immediately post intervention

  2. Cognitive determinants of intention assessed using questionnaire based upon the theory of planned behaviour.

    : 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.

    Measured: Immediately post intervention

  3. Self-efficacy assessed using questionnaire based upon Social Cognitive theory

    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.

    Measured: Immediately post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study start20 Feb 2017
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820103
Sponsor's protocol ID
CZH/4/1025
Acronym
RAPiD
Status last verified
Aug 2017
First submitted
21 Jun 2016
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25332805

  • Farquharson 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.

    PubMed 35942523

  • 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.

    PubMed 27779777

Questions about this trial

What is this clinical trial studying?

A study testing Text+Visual BCT-based intervention and Text-only BCT intervention in people with Acute Coronary Syndrome, run by Edinburgh Napier University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barbara Farquharson, PhD (0131 455 3475, b.farquharson@napier.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820103, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.

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