dc.contributor.author | Kelly, M | |
dc.contributor.author | Steed, L | |
dc.contributor.author | Sohanpal, R | |
dc.contributor.author | Pinnock, H | |
dc.contributor.author | Barradell, A | |
dc.contributor.author | Dibao-Dina, C | |
dc.contributor.author | Mammoliti, K-M | |
dc.contributor.author | Wileman, V | |
dc.contributor.author | Rowland, V | |
dc.contributor.author | Newton, S | |
dc.contributor.author | Moore, A | |
dc.contributor.author | Taylor, S | |
dc.date.accessioned | 2021-08-17T07:58:41Z | |
dc.date.available | 2021-07-15 | |
dc.date.available | 2021-08-17T07:58:41Z | |
dc.date.issued | 2021-07-26 | |
dc.identifier.citation | Kelly, M., Steed, L., Sohanpal, R. et al. The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD). Trials 22, 495 (2021). https://doi.org/10.1186/s13063-021-05460-w | en_US |
dc.identifier.other | ARTN 495 | |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/73658 | |
dc.description.abstract | Background: TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the
psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety
and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals
were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention)
under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process
evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and
mechanisms has been adopted.
Methods: We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods
design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with
patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of
the intervention; and exploration with all stakeholders (including management/policy-makers) on future
implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on
implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed
before the trial outcomes are known using analytic induction and constant comparison to develop themes.
Findings from the different elements will be reported separately and then integrated.
Conclusion: Detailed description and analysis of study processes in a research trial such as TANDEM enables
research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this
way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised
and makes it possible to explore issues arising for post-trial study implementation.
Trial registration: ISRCTN ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018.
Process evaluation protocol version 4.0, 1 November 2020. | en_US |
dc.publisher | BioMed Central | en_US |
dc.relation.ispartof | TRIALS | |
dc.rights | Creative Commons Attribution 4.0 International License | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Process evaluation | en_US |
dc.subject | Implementation | en_US |
dc.subject | Complex intervention | en_US |
dc.subject | Chronic obstructive pulmonary disease (COPD) | en_US |
dc.subject | Depression | en_US |
dc.subject | Anxiety | en_US |
dc.subject | Cognitive behavioural therapy (CBT) | en_US |
dc.title | The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD) | en_US |
dc.type | Article | en_US |
dc.rights.holder | © The Author(s). 2021 | |
dc.identifier.doi | 10.1186/s13063-021-05460-w | |
pubs.author-url | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000678628100009&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=612ae0d773dcbdba3046f6df545e9f6a | en_US |
pubs.issue | 1 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 22 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |
qmul.funder | A tailored, cognitive behavioural approach intervention for mild to moderate anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD): A randomised controlled trial (TANDEM Tailored intervention for ANxiety and DEpression Management in COPD)::NIHR Evaluation Trials and Studies Coordinating Centre | en_US |