ArticleTrials2021
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).
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 17 citations in OpenAlex.
- Assessing competence of primary care respiratory healthcare professionals to deliver a psychologically-based intervention for people with COPD: results from the TANDEM study.NPJ primary care respiratory medicine · 2025Trial
- A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.Health technology assessment (Winchester, England) · 2024Trial
- Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.The European respiratory journal · 2023Trial
- Beyond Spirometry: Dyspnea, Functional Limitation, and Psychological Distress Across GOLD Stages in COPD-A Multicenter Observational Study.Medicina (Kaunas, Lithuania) · 2026Observational
- Development of a Traditional Chinese Medicine Lifestyle Medicine Program for Depression: A Multi-Method Study.Healthcare (Basel, Switzerland) · 2026Article
- Identifying self-care needs of patients with chronic obstructive pulmonary disease to design a mobile phone application-based self-care program.Journal of education and health promotion · 2026Article
- Applying a cognitive behavioural approach in COPD: views of respiratory professionals.ERJ open research · 2025Article
- Patient perspectives on the Tailored intervention for Anxiety and Depression Management in COPD (TANDEM): a qualitative evaluation.BMC health services research · 2024Article
- Article
- Enhancing and assessing fidelity in the TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD) trial: development of methods and recommendations for research design.BMC medical research methodology · 2022Article
- Correlation of Serum IL-18, BDNF, and IL-1Computational and mathematical methods in medicine · 2022Article
Corrections and comments
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Authors and funding
12 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundTANDEM 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.
methodsWe 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.
conclusionDetailed 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 registrationISRCTN ISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.