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

Jean Bourbeau, Kim L Lavoie, Maria Sedeno, Dorothy De Sousa, Damijan Erzen, Alan Hamilton, François Maltais, Thierry Troosters, Nancy Leidy, Jean Bourbeau, Kim L Lavoie, Maria Sedeno, Dorothy De Sousa, Damijan Erzen, Alan Hamilton, François Maltais, Thierry Troosters, Nancy Leidy

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.

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/

Figures

Figure 1
Figure 1
Decline in lung function in chronic obstructive pulmonary disease is associated with inactivity and avoiding exercise, leading to a spiral of declining patient condition. Reprinted from The American Journal of Medicine, Vol 119 (10A), Reardon et al. Functional status and quality of life in chronic obstructive pulmonary disease, S32–37, Copyright 2006, with permission from Elsevier.
Figure 2
Figure 2
Overview of the behaviour-change programme. COPD, chronic obstructive pulmonary disease.
Figure 3
Figure 3
Data flow between SCMs and site coordinators. CCM, Country Case Manager; SCM, Site Case Manager.

References

    1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2015 2015. (accessed 1 Jul 2015).
    1. Pitta F, Troosters T, Spruit MA et al. . Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2005;171:972–7. 10.1164/rccm.200407-855OC
    1. Troosters T, Sciurba F, Battaglia S et al. . Physical inactivity in patients with COPD, a controlled multi-center pilot-study. Respir Med 2010;104:1005–11. 10.1016/j.rmed.2010.01.012
    1. Reardon JZ, Lareau SC, ZuWallack R. Functional status and quality of life in chronic obstructive pulmonary disease. Am J Med 2006;119:32–7. 10.1016/j.amjmed.2006.08.005
    1. Pitta F, Troosters T, Probst VS et al. . Physical activity and hospitalization for exacerbation of COPD. Chest 2006;129:536–44. 10.1378/chest.129.3.536
    1. Garcia-Aymerich J, Serra I, Gómez FP et al. . Physical activity and clinical and functional status in COPD. Chest 2009;136:62–70. 10.1378/chest.08-2532
    1. Vaes AW, Garcia-Aymerich J, Marott JL et al. . Changes in physical activity and all-cause mortality in COPD. Eur Respir J 2014;44:1199–209. 10.1183/09031936.00023214
    1. Watz H, Pitta F, Rochester CL et al. . An official European Respiratory Society statement on physical activity in COPD. Eur Respir J 2014;44:1521–37. 10.1183/09031936.00046814
    1. Maltais F, Mahler DA, Pepin V et al. . Effect of fluticasone propionate/salmeterol plus tiotropium versus tiotropium on walking endurance in COPD. Eur Respir J 2013;42:539–41. 10.1183/09031936.00074113
    1. Maltais F, Gáldiz Iturri JB, Kirsten A et al. . Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD [abstract]. Eur Respir J 2014;44(Suppl 58):abs P283 10.1183/09031936.00024314
    1. Maltais F, Singh S, Donald A et al. . Effects of a combination of vilanterol and umeclidinium on exercise endurance in subjects with COPD: two randomised clinical trials [abstract]. Eur Respir J 2013;42(Suppl 57):abs P761 10.1183/09031936.00074113
    1. Maltais F, Kirsten A-M, Hamilton A et al. . Evaluation of the effects of olodaterol on exercise endurance in patients with COPD: results from two 6-week studies [abstract]. Chest 2013;144(No.4 Meeting Abstracts):abs 748A 10.1378/chest.1701949
    1. Pitta F, Troosters T, Probst VS et al. . Are patients with COPD more active after pulmonary rehabilitation? Chest 2008;134:273–80. 10.1378/chest.07-2655
    1. Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns 2004;52:271–7. 10.1016/S0738-3991(03)00102-2
    1. Glanz K, Rimer BK, Viswanath K, eds. Health behavior and health education. Theory, research, and practice. 4th edn San Francisco, CA: John Wiley & Sons, Inc., 2008.
    1. Rouleau CR, Lavoie KL, Bacon SL et al. . Training healthcare providers in motivational communication for promoting physical activity and exercise in cardiometabolic health settings: do we know what we are doing? Curr Cardiovasc Risk Rep 2015;9:29 10.1007/s12170-015-0457-2
    1. Leidy NK, Kimel M, Ajagbe L et al. . Designing trials of behavioral interventions to increase physical activity in patients with COPD: insights from the chronic disease literature. Respir Med 2014;108:472–81. 10.1016/j.rmed.2013.11.011
    1. Rutledge T, Redwine LS, Linke SE et al. . A meta-analysis of mental health treatments and cardiac rehabilitation for improving clinical outcomes and depression among patients with coronary heart disease. Psychosom Med 2013;75:335–49. 10.1097/PSY.0b013e318291d798
    1. Lavoie KL, Campbell TS, Bacon SL. Behavioral medicine trial design: time for a change. Arch Intern Med 2012;172:1350–1. 10.1001/archinternmed.2012.2578
    1. Troosters T, Bourbeau J, Maltais F et al. . Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open 2016;6:e010106 10.1001/archinternmed.2012.2578
    1. Leidy NK, Knebel A. In search of parsimony: reliability and validity of the Functional Performance Inventory-Short Form. Int J Chron Obstruct Pulmon Dis 2010;5:415–23.
    1. Leidy NK, Hamilton A, Becker K. Assessing patient report of function: content validity of the Functional Performance Inventory-Short Form (FPI-SF) in patients with chronic obstructive pulmonary disease (COPD). Int J Chron Obstruct Pulmon Dis 2012;7:543–54. 10.2147/COPD.S32032
    1. Nasreddine ZS, Phillips NA, Bédirian V et al. . The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005;53:695–9. 10.1111/j.1532-5415.2005.53221.x
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x
    1. Spitzer RL, Kroenke K, Williams JBW et al. . Validation and utility of a self-report version of PRIME-MD: the PHQ Primary Care Study. JAMA 1999;282:1737–44. 10.1001/jama.282.18.1737
    1. Spitzer RL, Williams JBW, Kroenke K et al. . Validity and utility of the PRIME-MD Patient Health Questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study. Am J Obstet Gynecol 2000;183:759–69. 10.1067/mob.2000.106580
    1. Living Well with COPD™ 2015. (accessed 12 Jan 2015).
    1. Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care. Helping patients change behavior. New York, NY: The Guilford Press, 2008.
    1. American Thoracic Society. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111–17. 10.1164/ajrccm.166.1.at1102
    1. Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000;31:73–86. 10.1016/S0005-7916(00)00012-4
    1. Garber CE, Allsworth JE, Marcus BH et al. . Correlates of the stages of change for physical activity in a population survey. Am J Public Health 2008;98:897–904. 10.2105/AJPH.2007.123075
    1. Jones PW, Quirk FH, Baveystock CM et al. . A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis 1992;145:1321–7.
    1. Levesque CS, Williams GC, Elliot D et al. . Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Health Educ Res 2007;22:691–702. 10.1093/her/cyl148
    1. Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care 1998;21:1644–51. 10.2337/diacare.21.10.1644
    1. Chan AW, Tetzlaff JM, Gotzsche PC et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
    1. Bourbeau J. Making pulmonary rehabilitation a success in COPD. Swiss Med Wkly 2010;140:w13067 10.4414/smw.2010.13067
    1. Bourbeau J. The role of collaborative self-management in pulmonary rehabilitation. Semin Respir Crit Care Med 2009;30:700–7. 10.1055/s-0029-1242639
    1. Bacon SL, Lavoie KL, Ninot G et al. . An international perspective on improving the quality and potential of behavioral clinical trials. Curr Cardiovasc Risk Rep 2015;9:427 10.1007/s12170-014-0427-0

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