Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial

Autor: Chan, Claire L, Smuk, Melanie, Sohanpal, Ratna, Pinnock, Hilary, Taylor, Stephanie JC, TANDEM Investigators
Rok vydání: 2020
Předmět:
Statistical analysis plan
medicine.medical_specialty
Referral
Cost-Benefit Analysis
medicine.medical_treatment
Psychological intervention
Medicine (miscellaneous)
Anxiety
Psychosocial Intervention
Hospital Anxiety and Depression Scale
01 natural sciences
Update
law.invention
Pulmonary Disease
Chronic Obstructive
010104 statistics & probability
03 medical and health sciences
0302 clinical medicine
Complex intervention
Multi-centre
Randomized controlled trial
law
Intervention (counseling)
Partial clustering
medicine
Humans
Pharmacology (medical)
Pulmonary rehabilitation
Cognitive behavioural approach
030212 general & internal medicine
0101 mathematics
lcsh:R5-920
Pragmatic randomised controlled trial
Internal pilot
Depression
business.industry
Chronic obstructive pulmonary disease
Tailored Intervention
Clinical effectiveness
Quality of Life
Physical therapy
medicine.symptom
lcsh:Medicine (General)
business
Zdroj: Trials, Vol 21, Iss 1, Pp 1-9 (2020)
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04786-1
Popis: Background The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease. Methods and design TANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6 months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales. Results This article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant. Trial registration ISRCTN registry ISRCTN59537391. Registered on 20 March 2017.
Databáze: OpenAIRE
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