title: Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation.
abstract: BACKGROUND
  Chronic obstructive pulmonary disease is generally progressive and associated with reduced physical activity. Both pharmacological therapy and exercise training can improve exercise capacity; however, these are often not sufficient to change the amount of daily physical activity a patient undertakes. Behaviour-change self-management programmes are designed to address this, including setting motivational goals and providing social support. We present and discuss the necessary methodological considerations when integrating behaviour-change interventions into a multicentre study.
  
  
  METHODS
  PHYSACTO is a 12-week phase IIIb study assessing the effects on exercise capacity and physical activity of once-daily tiotropium+olodaterol 5/5 µg with exercise training, tiotropium+olodaterol 5/5 µg without exercise training, tiotropium 5 µg or placebo, with all pharmacological interventions administered via the Respimat inhaler. Patients in all intervention arms receive a behaviour-change self-management programme to provide an optimal environment for translating improvements in exercise capacity into increases in daily physical activity. To maximise the likelihood of success, special attention is given in the programme to: (1) the Site Case Manager, with careful monitoring of programme delivery; (2) the patient, incorporating patient-evaluation/programme-evaluation measures to guide the Site Case Manager in the self-management intervention; and (3) quality assurance, to help identify and correct any problems or shortcomings in programme delivery and ensure the effectiveness of any corrective steps. This paper documents the comprehensive methods used to optimise and standardise the behaviour-change self-management programme used in the study to facilitate dialogue on the inclusion of this type of programme in multicentre studies.
  
  
  BACKGROUND
  The study has been approved by the relevant Institutional Review Boards, Independent Ethics Committee and Competent Authority according to national and international regulations. The results of this study will be disseminated through relevant, peer-reviewed journals and international conference presentations.
  
  
  BACKGROUND
  NCT02085161.
authors.affiliation: Respiratory Epidemiology Clinical Research Unit, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
authors.forename: Jean
authors.initials: J
authors.lastname: Bourbeau
authors.affiliation: Montreal Behavioural Medicine Centre, Research Centre, Hopital du Sacré-Coeur de Montreal, Montreal, Quebec, Canada Department of Psychology, University of Quebec at Montreal (UQAM), Montreal, Quebec, Canada.
authors.forename: Kim L
authors.initials: KL
authors.lastname: Lavoie
authors.affiliation: Respiratory Epidemiology Clinical Research Unit, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
authors.forename: Maria
authors.identifier: http://orcid.org/0000-0001-7108-1512
authors.initials: M
authors.lastname: Sedeno
authors.affiliation: Boehringer Ingelheim (Canada) Ltd., Burlington, Ontario, Canada.
authors.forename: Dorothy
authors.initials: D
authors.lastname: De Sousa
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
authors.forename: Damijan
authors.initials: D
authors.lastname: Erzen
authors.affiliation: Boehringer Ingelheim (Canada) Ltd., Burlington, Ontario, Canada.
authors.forename: Alan
authors.initials: A
authors.lastname: Hamilton
authors.affiliation: Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Université Laval, Quebec, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Maltais
authors.affiliation: KU Leuven, Department of Rehabilitation Sciences, Pulmonary Rehabilitation and Respiratory Division, University Hospital Leuven, Leuven, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Troosters
authors.affiliation: Evidera, Bethesda, Maryland, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Leidy
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia; D048588:Benzoxazines / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002170:Canada; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005060:Europe; D005080:Exercise Test; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D000069447:Tiotropium Bromide / Q000008:administration & dosage*; D016896:Treatment Outcome; D014481:United States; D016138:Walking
chemical_list: D048588:Benzoxazines; D001993:Bronchodilator Agents; C549647:olodaterol; D000069447:Tiotropium Bromide