An Intervention to Support Medication Adherence Following Acute Coronary Syndrome

NCT02967588 | Completed

• 1 other identifier: v1 06-09-16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndrome

Keywords

Medication adherence; Behavioural intervention; Acute coronary syndrome; Medication beliefs; Implementation intentions

Outcome Measures

Primary Outcomes (1)

• 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).

  During index hospitalisation, within two days of admission.

Secondary Outcomes (2)

• Initial patient study feedback

  During index hospitalisation, within two days of admission.

• Detailed patient study feedback

  Within three weeks post-discharge

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Intervention group

Interventions

Intervention group BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: November 18, 2016
• Study Start: March 6, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: July 2, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)