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)
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 mod...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-07-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05460-w |
| _version_ | 1819151820924125184 |
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| author | Moira Kelly Liz Steed Ratna Sohanpal Hilary Pinnock Amy Barradell Clarisse Dibao-Dina Kristie-Marie Mammoliti Vari Wileman Vickie Rowland Sian Newton Anna Moore Stephanie Taylor |
| author_facet | Moira Kelly Liz Steed Ratna Sohanpal Hilary Pinnock Amy Barradell Clarisse Dibao-Dina Kristie-Marie Mammoliti Vari Wileman Vickie Rowland Sian Newton Anna Moore Stephanie Taylor |
| author_sort | Moira Kelly |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-22T14:39:29Z |
| format | Article |
| id | doaj.art-733bcdcadd6f4542b5575c855f345af6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-22T14:39:29Z |
| publishDate | 2021-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-733bcdcadd6f4542b5575c855f345af62022-12-21T18:22:34ZengBMCTrials1745-62152021-07-0122111110.1186/s13063-021-05460-wThe 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)Moira Kelly0Liz Steed1Ratna Sohanpal2Hilary Pinnock3Amy Barradell4Clarisse Dibao-Dina5Kristie-Marie Mammoliti6Vari Wileman7Vickie Rowland8Sian Newton9Anna Moore10Stephanie Taylor11Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and DentistryCentre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and DentistryCentre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and DentistryAllergy and Respiratory Research Group, Usher Institute of Population Health Sciences and InformaticsDepartment of Respiratory Sciences, College of Life Sciences, NIHR Leicester Biomedical Research Centre- Respiratory Glenfield Hospital, University of LeicesterUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246Birmingham Clinical Trials Unit and WHO Collaborating Centre for Global Women’s Health Research, University of BirminghamCentre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and DentistryDepartment of Health & Social Sciences, University of the West of England, Frenchay CampusCentre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and DentistryThe Education Academy, Barts Health NHS Trust, Royal London HospitalCentre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and DentistryAbstract 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.https://doi.org/10.1186/s13063-021-05460-wProcess evaluationImplementationComplex interventionChronic obstructive pulmonary disease (COPD)DepressionAnxiety |
| spellingShingle | Moira Kelly Liz Steed Ratna Sohanpal Hilary Pinnock Amy Barradell Clarisse Dibao-Dina Kristie-Marie Mammoliti Vari Wileman Vickie Rowland Sian Newton Anna Moore Stephanie Taylor 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 Process evaluation Implementation Complex intervention Chronic obstructive pulmonary disease (COPD) Depression Anxiety |
| 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Process evaluation Implementation Complex intervention Chronic obstructive pulmonary disease (COPD) Depression Anxiety |
| url | https://doi.org/10.1186/s13063-021-05460-w |
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