NCT02481024

Brief Summary

Background: Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. After a cardiac event, transitioning from hospital into primary care can be problematic if it is not organised or coordinated properly. Patients can often find themselves unprepared and lacking the necessary information for self-management of their disease. The impact of care transition on medication adherence has not been studied in ACS. Objectives: This study will explore how an ACS patients' journey from hospital into primary care affects medicines use. Further, to understand how medicine information is communicated and how this influences patient beliefs about medicines. Methods: This is an interview study with recently hospitalised ACS patients discussing medication beliefs, communication of medicine information and the challenges when transitioning from specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An inductive thematic analysis will be used to identify, construct and analyse patterns in the data and to develop a framework analysis. Analysis will be an iterative process conducted in parallel with data collection to highlight when data saturation has been reached. Dissemination: The primary objective is to develop a pharmacist-led behaviour change intervention to improve rates of medication adherence following an ACS. The in-depth patient data collected in this current study will contribute to the design and development of the intervention. Understanding the research topic from the patients' perspective is a necessity when designing an intervention targeting behaviour change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 18, 2018

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

June 18, 2015

Last Update Submit

January 17, 2018

Conditions

Keywords

QualitativeCare transitionMedication

Outcome Measures

Primary Outcomes (1)

  • Patient experiences

    Analysing patients' experiences of care transition and its impact on adherence and treatment beliefs. This will be done using thematic analysis to identify, construct and assess patterns in the qualitative data to develop a framework analysis.

    3-4 weeks after discharged from hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalised after an acute coronary syndrome event.

You may qualify if:

  • over 18 years of age
  • have a confirmed index diagnosis of ACS
  • have sufficient spoken English to partake in an interview

You may not qualify if:

  • under 18 years of age
  • lack the level of spoken English required to be interviewed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 25, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 18, 2018

Record last verified: 2016-08

Locations