15
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation

      protocol

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Introduction

          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 and analysis

          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.

          Ethics and dissemination

          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.

          Trial registration number

          NCT02085161.

          Related collections

          Most cited references20

          • Record: found
          • Abstract: found
          • Article: not found

          Characteristics of physical activities in daily life in chronic obstructive pulmonary disease.

          Quantification of physical activities in daily life in patients with chronic obstructive pulmonary disease has increasing clinical interest. However, detailed comparison with healthy subjects is not available. Furthermore, it is unknown whether time spent actively during daily life is related to lung function, muscle force, or maximal and functional exercise capacity. We assessed physical activities and movement intensity with the DynaPort activity monitor in 50 patients (age 64 +/- 7 years; FEV1 43 +/- 18% predicted) and 25 healthy elderly individuals (age 66 +/- 5 years). Patients showed lower walking time (44 +/- 26 vs. 81 +/- 26 minutes/day), standing time (191 +/- 99 vs. 295 +/- 109 minutes/day), and movement intensity during walking (1.8 +/- 0.3 vs. 2.4 +/- 0.5 m/second2; p < 0.0001 for all), as well as higher sitting time (374 +/- 139 vs. 306 +/- 108 minutes/day; p = 0.04) and lying time (87 +/- 97 vs. 29 +/- 33 minutes/day; p = 0.004). Walking time was highly correlated with the 6-minute walking test (r = 0.76, p < 0.0001) and more modestly to maximal exercise capacity, lung function, and muscle force (0.28 < r < 0.64, p < 0.05). Patients with chronic obstructive pulmonary disease are markedly inactive in daily life. Functional exercise capacity is the strongest correlate of physical activities in daily life.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Psychometric properties of the credibility/expectancy questionnaire.

            The present research evaluated the psychometric properties of the credibility/expectancy questionnaire, a quick and easy-to-administer scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. The results suggested that this questionnaire derives the two predicted factors (cognitively based credibility and relatively more affectively based expectancy) and that these factors are stable across different populations. Furthermore, the questionnaire demonstrated high internal consistency within each factor and good test-retest reliability. The expectancy factor predicted outcome on some measures, whereas the credibility factor was unrelated to outcome. The questionnaire is appended to the paper, yet the authors stress care when utilizing the scale. During the administration of the questionnaire, the participant sees two sections--one related to thinking and one related to feeling. However, the researcher needs to be aware that the 2 factors derived are not grouped into those questions. Instead credibility was found to be derived from the first three think questions and expectancy was derived from the fourth think question and the two feel questions.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors.

              Nearly 40% of mortality in the United States is linked to social and behavioral factors such as smoking, diet and sedentary lifestyle. Autonomous self-regulation of health-related behaviors is thus an important aspect of human behavior to assess. In 1997, the Behavior Change Consortium (BCC) was formed. Within the BCC, seven health behaviors, 18 theoretical models, five intervention settings and 26 mediating variables were studied across diverse populations. One of the measures included across settings and health behaviors was the Treatment Self-Regulation Questionnaire (TSRQ). The purpose of the present study was to examine the validity of the TSRQ across settings and health behaviors (tobacco, diet and exercise). The TSRQ is composed of subscales assessing different forms of motivation: amotivation, external, introjection, identification and integration. Data were obtained from four different sites and a total of 2731 participants completed the TSRQ. Invariance analyses support the validity of the TSRQ across all four sites and all three health behaviors. Overall, the internal consistency of each subscale was acceptable (most alpha values >0.73). The present study provides further evidence of the validity of the TSRQ and its usefulness as an assessment tool across various settings and for different health behaviors.
                Bookmark

                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                4 April 2016
                : 6
                : 4
                : e010109
                Affiliations
                [1 ]Respiratory Epidemiology Clinical Research Unit, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada
                [2 ]Montreal Behavioural Medicine Centre, Research Centre, Hopital du Sacré-Coeur de Montreal , Montreal, Quebec, Canada
                [3 ]Department of Psychology, University of Quebec at Montreal (UQAM) , Montreal, Quebec, Canada
                [4 ]Boehringer Ingelheim (Canada) Ltd. , Burlington, Ontario, Canada
                [5 ]Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riss, Germany
                [6 ]Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Université Laval , Quebec, Canada
                [7 ]KU Leuven, Department of Rehabilitation Sciences, Pulmonary Rehabilitation and Respiratory Division, University Hospital Leuven , Leuven, Belgium
                [8 ]Evidera , Bethesda, Maryland, USA
                Author notes
                [Correspondence to ] Dr Jean Bourbeau; jean.bourbeau@ 123456mcgill.ca
                Author information
                http://orcid.org/0000-0001-7108-1512
                Article
                bmjopen-2015-010109
                10.1136/bmjopen-2015-010109
                4823464
                27044576
                0332d5d0-5ec2-47e8-a1a9-791ef80a164d
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 25 September 2015
                : 29 January 2016
                : 1 February 2016
                Funding
                Funded by: Boehringer Ingelheim, http://dx.doi.org/10.13039/100008349;
                Categories
                Respiratory Medicine
                Protocol
                1506
                1731
                1730

                Medicine
                Medicine

                Comments

                Comment on this article