Study protocol for a randomized, controlled trial comparing the efficacy of two educational interventions to improve inhalation techniques in patients with chronic obstructive pulmonary disease (COPD): TIEPOC study

Drugs in Context

Volumn , Issue , 2014, Pages

  Leiva Fernández, José ^a   Leiva Fernández, Francisca ^b   Vázquez Alarcón, Rubén L ^b   García Ruiz, Antonio ^c   Prados Torres, Daniel ^b   Barnestein Fonseca, Pilar ^b  

^a Velez Sur Health Centre   (Spain)

^b Family and Community Medicine Teaching Unit of Malaga   (Spain)

^c UNIVERSITY OF MÁLAGA   (Spain)

Author keywords

COPD; Educational intervention; Inhalation techniques; Patient empowerment; Self management; Treatment adherence

Indexed keywords

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CLINICAL PROTOCOL; CONTROLLED STUDY; DRY POWDER INHALER; FEMALE; FOLLOW UP; FUNCTIONAL STATUS; GOOD CLINICAL PRACTICE; HEALTH CARE PERSONNEL; HUMAN; INHALATIONAL DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; METERED DOSE INHALER; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT EDUCATION; PRESSURIZED METERED DOSE INHALER; PRIMARY MEDICAL CARE; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; RISK REDUCTION; SAMPLE SIZE; SOCIAL SUPPORT;

EID: 84899741721     PISSN: 17451981     EISSN: 17404398     Source Type: Journal    
DOI: 10.7575/dic.212261.t001     Document Type: Article

References (36)

1. Dong YH, Lin HH, Shau WY, Wu YC, Chang CH, Lai MS. Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials. Thorax 2013;68:48-56. http://dx.doi.org/10.1136/thoraxjnl- 2012-201926
2. Takemura M, Mitsui K, Itotani M et al. Relationships between repeated instruction on inhalation therapy, medication adherence, and health status in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 2011;6:97-104. http://dx.doi.org/10.2147/COPD.S16173
3. Miravitlles M, Soler-Cataluña JJ, Calle M et al. Spanish COPD guidelines (GesEPOC): pharmacological treatment of stable COPD. Spanish Society of Pulmonology and Thoracic Surgery. Arch Bronconeumol 2012;48:247-57.
4. Broeders ME, Vincken W, Corbetta L. The ADMIT series - Issues in Inhalation Therapy. 7) Ways to improve pharmacological management of COPD: the importance of inhaler choice and inhalation technique. Prim Care Respir J 2011;20:338-43. http://dx.doi.org/10.4104/pcrj.2011.00062
5. Lavorini F, Magnan A, Dubus JC et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med 2008;102:593-604. http://dx.doi.org/10.1016/j.rmed.2007.11.003
6. Self TH, Wallace JL, George CM, Howard-Thompson A, Schrock SD. Inhalation therapy: help patients avoid these mistakes. J Fam Pract 2011;60:714-21.
7. Laureau SC, Hodder R. Teaching inhaler use in chronic obstructive pulmonary disease patients. J Am Acad Nurse Pract 2012;24:113-20. http://dx.doi.org/10.1111/j.1745-7599.2011.00681.x
8. Vestbo J, Anderson JA, Calverley PM et al. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax 2009;64:939-43. http://dx.doi.org/10.1136/thx.2009.113662
9. Broeders ME, Sanchis J, Levy ML, Crompton GK, Dekhuijzen PN. The ADMIT series - Issues in inhalation therapy. 2) Improving technique and clinical effectiveness. Prim Care Respir J 2009;18:76-82. http://dx.doi.org/10.4104/pcrj. 2009.00025
10. Vincken W, Deckhuijzen PR, Barnes P. The ADMIT series - Issues in inhalation therapy. 4) How to choose inhaler devices for the treatment of COPD. Prim Care Respir J 2010;19:10-20. http://dx.doi.org/10.4104/pcrj.2009.00062
11. Barnestein-Fonseca P, Leiva-Fernandez J, Acero-Guasch N, Garcia-Ruiz A, Prados-Torres JD, Leiva-Fernandez F. Técnicas de inhalación en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC). Eficácia de una instrucción periódica. Méd Fam (And) 2013;14:11-22.
12. Souza ML, Meneghini AC, Ferraz E, Vianna EO, Borges MC. Knowledge of and technique for using inhalation devices among asthma patients and COPD patients. J Bras Pneumol 2009;35:824-31.
13. van der Palen L, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J 1999;14:1034-7. http://dx.doi.org/10.1183/09031936.99.14510349
14. van der Palen J, Klein JJ, Kerkhoff AH, van Herwaarden CL. Evaluation of the effectiveness of four different inhalers in patients with chronic obstructive pulmonary disease. Thorax 1995;50:1183-7. http://dx.doi.org/10.1136/ thx.50.11.1183
15. Crompton GK, Barnes PJ, Broeders M et al. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med 2006;100:1479-94. http://dx.doi.org/10.1016/j.rmed.2006.01.008 (Pubitemid 44109117)
16. Giner J, Tálamo C, Plaza V. Consenso SEPAR-ALAT sobre terapia inhalada. Available at: http://issuu.com/separ/docs/consenso-separ-alat-sobre- terapia-i?e=3049452/6755996 [Last accessed 9 April 2014].
17. .Melani AS. Inhalatory therapy training: a priority challenge for the physician. Acta Biomed 2007;78:233-45. (Pubitemid 351599006)
18. .Melani A, Bonavia M, Cilenti V et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med 2011;105:930-8. http://dx.doi.org/10.1016/j.rmed.2011.01.005
19. Lavorini F, Corrigan CJ, Barners PJ et al. Retail sales of inhalation devices in European countries: so much for a global policy. Respir Med 2011;105:1099-113. http://dx.doi.org/10.1016/j.rmed.2011.03.012
20. Lenney J, Innes JA, Crompton CK. Inappropriate inhaler use: assessment of use and patient preference of seven inhalation devices. EDICI. Respir Med 2000;94(5):496-500. http://dx.doi.org/10.1053/rmed.1999.0767 (Pubitemid 30353008)
21. Lubin D. Inhaler use: Tell patients to purse their lips. J Fam Pract 2012;61:132.
22. Rau JL. Practical problems with aerosol therapy in COPD. Respir Care 2006;51:158-72. (Pubitemid 46888414)
23. Capstick TG, Clifton IJ. Inhaler technique and training in people with chronic obstructive pulmonary disease and asthma. Expert Rev Respir Med 2012;6:91-103. http://dx.doi.org/10.1586/ers.11.89
24. Global Initiative for Chronic Obstructive Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. Available at: http://www.goldcopd.org/guidelines-global-strategy-for- diagnosis-management.html [Last accessed April 10, 2014].
25. National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care. CG101. Available at: http://publications.nice. org.uk/chronic-obstructive-pulmonary-disease-cg101. [Last accessed April 10, 2014].
26. De Boeck K, Alifier M, Warnier G. Is the correct use of a dry powder inhaler (Turbohaler) age dependent? J Allergy Clin Immunol 1999;103:763-7. http://dx.doi.org/10.1016/S0091-6749(99)70417-3 (Pubitemid 29297576)
27. Bosnic-Anticevich SZ, Sinha H, So S, Reddel HK. Metered-dose inhaler technique: the effect of two educational interventions delivered in community pharmacy over time. J Asthma 2010;47:251-6. http://dx.doi.org/10.3109/ 02770900903580843
28. Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest 1984;85:751-8. http://dx.doi.org/10.1378/chest.85.6. 751 (Pubitemid 14121920)
29. Schilling RSF, Hughes JPW, Dingwall-Fordyce I. Disagreement between observers in an epidemiological study of respiratory disease. BMJ 1955;1:65-8. http://dx.doi.org/10.1136/bmj.1.4905.65
30. Ferrer M, Alonso J, Prieto L et al. Validity and reliability of the St George's Respiratory Questionnaire after adaptation to a different language and culture: the Spanish example. Eur Respir J 1996;9:1160-6. (Pubitemid 26231729)
31. Herdman M, Badía X, Berra S. El EuroQoL-5D: [A simple alternative for measuring health-related quality of life in primary care]. [Article in Spanish]. Aten Primaria 2001;28:425-30.
32. Bellón JA, Delgado A, del Luna-Castillo J, Lardelli P. [Validity and reliability of the family APGAR function test]. [Article in Spanish]. Aten Primaria 1996;18: 289-94.
33. Janevic MR, Janz NK, Dodge JA et al. The role of choice in health education intervention trials: a review and case study. Soc Sci Med 2003;56:1581-94. http://dx.doi.org/10.1016/S0277-9536(02)00158-2 (Pubitemid 36279490)
34. Fisher L, Dixon D, Jerson J. Intention to treat in clinical trials. In: Peace K, ed. Statistical issues in drug research and development. New York: Marcel Dekker, 1990.
35. Luque MJ. Eficacia de una intervención terapéutica multifactor sobre el exceso de peso en Atención Primaria. PhD thesis. University of Malaga, 2006.
36. Barnestein-Fonseca P, Leiva-Fernández J, Vidal-España F, García-Ruiz A, Prados-Torres D, Leiva-Fernández F. Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with Chronic Obstructive Pulmonary Disease (COPD): protocol for the ICEPOC study. Trials 2011;12:40. http://dx.doi.org/10.1186/1745-6215-12-40