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An Intervention to Support Medication Adherence Following Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention group
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Medication adherence, Behavioural intervention, Acute coronary syndrome, Medication beliefs, Implementation intentions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of ACS
  • ACS primary reason for hospitalization
  • Patients to be prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
  • Sufficient spoken English to participate in the study

Exclusion Criteria:

  • Developed ACS as a secondary condition (i.e. perioperative MI)
  • Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers)
  • Non-English speaking

Sites / Locations

  • Guy's and St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Treatment beliefs
Beliefs about medications will be compared pre-post intervention using responses from the BMQ-S, Separate necessity and concerns scores will be calculated (5-items each, total scores ranging 5-25) along with the BMQ differential (necessity score - concerns score) (Gujral et al., 2014).

Secondary Outcome Measures

Initial patient study feedback
Patients will complete a study feedback questionnaire which will determine its acceptability to patients (setting, timing, content, delivery method).
Detailed patient study feedback
Detailed patient feedback will be gathered 2-3 weeks after discharge via a phone call. A brief semi-structured interview will be undertaken and study acceptability will be assessed (setting, timing, content, delivery method). The follow up call will be audio recorded, transcribed and used to evaluate the intervention.

Full Information

First Posted
October 11, 2016
Last Updated
June 30, 2017
Sponsor
King's College London
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02967588
Brief Title
An Intervention to Support Medication Adherence Following Acute Coronary Syndrome
Official Title
Development and Feasibility of a Brief Hospital-Based Intervention to Support Medication Adherence Following Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background Medication adherence following acute coronary syndrome (ACS) is often sub-optimal and is associated with poor clinical outcomes. Non-adherence can be considered intentional or unintentional. Findings ways to improve adherence is an important area of research with widespread clinical implications, however, previous interventions have generally been ineffective. The investigators propose an intervention that challenges both intentional and unintentional non-adherence in patients hospitalised following ACS. Objectives The objective of this study is to determine the feasibility of a hospital-based intervention aimed at supporting medication adherence in patients following an ACS. Methods Patients admitted to hospital with an ACS will be recruited for this study. The study will target both intentional and unintentional non-adherence over two sessions through challenging treatment beliefs and formulating specific action plans to encourage habit formation. Patients will be asked to provide in-depth feedback around the acceptability of the intervention. As this is a feasibility study, outcomes (i.e. medication adherence) will not be collected. Dissemination If this study seems to be practical to deliver and acceptable to patients then it will inform the design of a future randomized-controlled pilot study to test the effectiveness of the intervention delivered by hospital pharmacists on a study outcome (i.e. medication adherence).
Detailed Description
Intervention details All stages of the intervention will take place during hospitalization. Firstly, patients will complete a questionnaire based on the Beliefs about Medication Questionnaire-Specific (BMQ-S) (Horne & Weinmen, 1999). Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. The aim is to identify any negative or erroneous beliefs patients have that may prevent them from taking their medicines after they leave the hospital. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose'. The aim is to make taking their medicines as much a part of their daily routine as possible. Prior to discharge, patients will complete the beliefs questionnaire again to see if there has been any shift in their beliefs about medications. Patients will also be asked to provide detailed feedback about the study. The investigators want to know whether the intervention setting (i.e. hospital-based), timing (i.e. straight after an ACS), content (i.e. targeting both intentional and unintentional non-adherence) and interventionist (i.e. PhD candidate) seem to be acceptable to patients. Feedback will be gathered after completion of the intervention and also during a follow up phone call 2-3 weeks after discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Medication adherence, Behavioural intervention, Acute coronary syndrome, Medication beliefs, Implementation intentions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
All stages of the intervention will take place during hospitalization. Patients will complete a questionnaire about their personal beliefs about medicines. Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. Any negative beliefs or concerns will be discussed and beliefs about drug necessity will be encouraged. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose'). Prior to discharge, patients will complete the beliefs questionnaire again to see if there has been any shift in their beliefs about medications. Patients will also be asked to provide detailed feedback about the study. The investigators want to know whether the intervention setting, timing, content and delivery method seem to be acceptable to patients.
Primary Outcome Measure Information:
Title
Treatment beliefs
Description
Beliefs about medications will be compared pre-post intervention using responses from the BMQ-S, Separate necessity and concerns scores will be calculated (5-items each, total scores ranging 5-25) along with the BMQ differential (necessity score - concerns score) (Gujral et al., 2014).
Time Frame
During index hospitalisation, within two days of admission.
Secondary Outcome Measure Information:
Title
Initial patient study feedback
Description
Patients will complete a study feedback questionnaire which will determine its acceptability to patients (setting, timing, content, delivery method).
Time Frame
During index hospitalisation, within two days of admission.
Title
Detailed patient study feedback
Description
Detailed patient feedback will be gathered 2-3 weeks after discharge via a phone call. A brief semi-structured interview will be undertaken and study acceptability will be assessed (setting, timing, content, delivery method). The follow up call will be audio recorded, transcribed and used to evaluate the intervention.
Time Frame
Within three weeks post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of ACS ACS primary reason for hospitalization Patients to be prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers) Sufficient spoken English to participate in the study Exclusion Criteria: Developed ACS as a secondary condition (i.e. perioperative MI) Not prescribed medications for secondary prevention (i.e. antiplatelet drugs, statins, ACEi, ARBs, β-blockers) Non-English speaking
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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An Intervention to Support Medication Adherence Following Acute Coronary Syndrome

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