Interpreting the Processes of the UMPIRE Trial (INPUT): the design of a process evaluation of a fixed dose combination (FDC) strategy to improve adherence to cardiovascular medications – a qualitative study.

Salam, Abdul; Stewart, Frances; Singh, Kavita; Thom, Simon; Jame Williams, Hilarie; Patel, Anushka; Jan, Stephen; Laba, Tracey; Prabhakaran, Dorairaj; Maulik, Pallab; Day, Sophie E. and Ward, Helen. 2013. Interpreting the Processes of the UMPIRE Trial (INPUT): the design of a process evaluation of a fixed dose combination (FDC) strategy to improve adherence to cardiovascular medications – a qualitative study. INterpreting the Processes of the UMPIRE Trial (INPUT): protocol for a qualitative process evaluation study of a fixed-dose combination (FDC) strategy to improve adherence to cardiovascular medications, 3, [Article]

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Abstract or Description

Introduction This paper describes a planned process evaluation of the Use of a Multidrug Pill In Reducing Cardiovascular Events (UMPIRE) trial, one of several randomised clinical trials taking place globally to assess the potential of cardiovascular drugs as a fixed-dose combination (polypill) in cardiovascular disease prevention. A fixed-dose combination may be a promising strategy for promoting adherence to medication; alleviating pill burden through simplifying regimens and reducing cost. This process evaluation will complement the UMPIRE trial by using qualitative research methods to inform understanding of the complex interplay of factors that underpin trial outcomes.

Methods A series of semistructured, in-depth interviews with local health professionals and UMPIRE trial participants in India and the UK will be undertaken. The aim is to understand their views and experiences of the trial context and of day-to-day use of medications more generally. The grounded theory approach will be used to analyse data and help inform the processes of the UMPIRE trial.

Ethics and dissemination The study has received ethical approval for all sites in the UK and India where trial participant interviews will be undertaken. The process evaluation will help inform and enhance the understanding of the UMPIRE trial results and its applicability to clinical practice as well as shaping policy regarding strategies for improving cardiovascular medication adherence.

Item Type:

Article

Identification Number (DOI):

https://doi.org/10.1136/bmjopen-2012-002313

Additional Information:

Copyright information: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

Departments, Centres and Research Units:

Anthropology

Dates:

DateEvent
2 April 2012Accepted
1 January 2013Published
22 May 2013Published Online

Item ID:

19972

Date Deposited:

03 Mar 2017 17:48

Last Modified:

29 Apr 2020 16:25

Peer Reviewed:

Yes, this version has been peer-reviewed.

URI:

https://research.gold.ac.uk/id/eprint/19972

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