Ellard, David R., Taylor, Stephanie J. C., Parsons, Suzanne and Thorogood, Margaret (2011) The OPERA trial : a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation. Trials, Vol.12 (No.28). doi:10.1186/1745-6215-12-28 ISSN 1745-6215.

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Abstract

Background: The OPERA trial is large cluster randomised trial testing a physical activity intervention to address
depression amongst people living in nursing and residential homes for older people. A process evaluation was
commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the
cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including
study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the
structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation
are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential
implementation of the physical activity intervention on a wider scale.
Methods/design: Quantitative data on recruitment of homes and individuals is being collected. For homes in the
intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation
in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is
monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of
eight homes (six intervention and two control).
Discussion: Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings
published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the
potential to assist in interpreting and understanding trial results as well as informing future roll-outs of
interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the
trial outcome evaluation.

Item Type:	Journal Article
Subjects:	R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Depression in old age -- Treatment, Exercise for older people, Old age homes
Journal or Publication Title:	Trials
Publisher:	BioMed Central Ltd.
ISSN:	1745-6215
Official Date:	2 February 2011
Dates:	Date Event 2 February 2011 Published
Volume:	Vol.12
Number:	No.28
DOI:	10.1186/1745-6215-12-28
Status:	Peer Reviewed
Access rights to Published version:	Open Access (Creative Commons)
Funder:	National Institute for Health Research (Great Britain) (NIHR), NHS R & D HTA Programme (Great Britain) (HTA), Advantage West Midlands (AWM), Birmingham Science City
Grant number:	06/02/01 (HTA)

Data sourced from Thomson Reuters' Web of Knowledge

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