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Recruitment

The recruitment goal for the TANDEM main trial is 430 participants.

There are many NHS organisations collaborating in the study. The study sites include: Homerton University Hospital NHS Foundation Trust (HUHFT) plus NHS City and Hackney CCG, Imperial College Healthcare NHS Trust (ICHNT), NHS North West London CCG, Guy's and St Thomas' NHS Foundation Trust (GSTT), King's College Hospital NHS Trust (KCH), NHS South London CCGs, Berkshire Healthcare NHS Foundation Trust (BHFT), Southern Health NHS Foundation Trust (SHFT), University Hospitals of Coventry and Warwickshire (UHCW), NHS Coventry and Rugby CCG, Southern Warwickshire Foundation Trust (SWFT), University Hospitals of Leicestershire (UHL), Leicestershire Partnership Trust (LPT), NHS Leicestershire CCGs, Sandwell and West Birmingham Hospitals NHS Trust (SWBH) and the North Bristol NHS Trust (NBT).

The inclusion criteria for patients for TANDEM are:
  • Adults with a confirmed diagnosis of COPD, post bronchodilator FEV1/FVC ratio <70%
  • Moderate, severe or very severe COPD severity on spirometry, FEV1 <80% predicted
  • Patients with probable mild or moderate anxiety as determined by the Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A) scores ≥8 to ≤15; and/or probable mild or moderate depression as determined by Hospital Anxiety and Depression Scale – Depression Subscale (HADS-D) scores ≥8 to ≤15
  • Eligible to attend assessment appointment at their local pulmonary rehabilitation service at the time of randomisation i.e. 12 months have elapsed since last undertook PR or participant has another indication for PR referral (e.g. recent deterioration; recent hospitalisation with an acute exacerbation of COPD)
  • Patients who have been offered PR previously but declined the offer or did not complete PR will be included
The exclusion criteria for patients for TANDEM are:
  • Patients with both HADS-A score and a HADS-D score <8 (within normal range)
  • Unable to give valid consent
  • HADS depression or anxiety subscale score greater than 15 (suggestive of possible severe anxiety/depression)
  • If a referral to PR has been made, the patient is ineligible if they have agreed to attend PR sessions and are to commence < 4/52 at screening visit, (as confirmed in a PR appointment letter or by the PR team). The rationale for this exclusion is that the participant will not have time to receive a sufficient dose of the intervention prior to starting PR.
  • Severe uncontrolled psychological or psychiatric disorder e.g. schizophrenia, bipolar disorder, struggling to cope as a result of their personality disorder, uncontrolled substance abuse (alcoholism, illegal drugs) that would make them unsuitable for the intervention
  • Ineligible for pulmonary rehabilitation at their local PR service at the time of randomisation (typically if they had undertaken a course of PR in the last 12 months and there were no new clinical indications for PR[19]
  • A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control e.g. rheumatoid arthritis or osteoarthritis, multiple sclerosis, chronic widespread pain syndrome, previous cerebral vascular event that patient would not be eligible for pulmonary rehabilitation
  • Patients with moderate/severe cognitive impairment
  • In receipt of a psychological intervention primarily directed at helping to manage anxiety or depression in the last 6 months (NB those on antidepressants/ anxiolytics not excluded)
  • Patients currently involved in another clinical trial related to COPD (to reduce study participation burden on participants).
  • Not sufficiently fluent in English to be able to complete the intervention, questionnaires (NB the questionnaires are supervised self-complete, but can be read to participants if necessary, so poor literacy would not exclude individuals who are otherwise sufficiently fluent in English).
The inclusion criteria for carers for TANDEM are:
  • Identified by a participant with COPD in the study as a ‘particular family caregiver or friend who helps them’ whom they would be happy for us to invite to join the study
The exclusion criteria for carers for TANDEM are:
  • Unable to give valid consent
  • Not sufficiently fluent in English to be able to complete the questionnaires.