NCT02820103

Brief Summary

  1. 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. 2.To determine the most effective mode of delivery by comparing the text+visual BCT-based intervention with text-only BCT-based intervention.
  3. 3.To investigate any unintended consequences of the intervention on intentions to phone an ambulance for non-life-threatening symptoms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

June 21, 2016

Last Update Submit

August 14, 2017

Conditions

Keywords

Patient delayBehaviour changeIntervention Modelling Experiment

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 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.

Behavioral: Leaflet information (control)

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

Behavioral: Text+Visual BCT-based interventionBehavioral: Leaflet information (control)

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.

Behavioral: Text-only BCT interventionBehavioral: Leaflet information (control)

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.

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

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.

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

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.

Information leaflet (control)Text+Visual BCT-based intervention (Intervention Group 1)Text-only BCT-based intervention (Intervention Group 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

NHS Tayside

Dundee, Tayside, DD1 9SY, United Kingdom

RECRUITING

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: 25332805BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Barbara Farquharson, PhD

CONTACT

Brian Williams, PhD

CONTACT

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

Locations