Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-01 @ 4:17 PM
Study NCT ID:
NCT03144557
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the inhalation technique', 'timeFrame': 'Baseline and every session (48-72 hours)', 'description': 'If the patient that presented errors or mistakes corrected inhalation technique'}], 'secondaryOutcomes': [{'measure': 'Type of error', 'timeFrame': 'Baseline', 'description': 'Frequent errors in inhalation technique using different inhaler devices'}, {'measure': 'Inhalation device', 'timeFrame': 'Baseline', 'description': 'Inhaler that presents the greatest number of mistakes'}, {'measure': "Patient's characteristics", 'timeFrame': 'Baseline', 'description': 'Characteristics of the patients who do not perform the inhalation technique correctly and those who, despite having completed the education protocol, continue to perform it incorrectly'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Education', 'COPD', 'Inhalation Devices'], 'conditions': ['COPD', 'Education']}, 'referencesModule': {'references': [{'pmid': '28182569', 'type': 'BACKGROUND', 'citation': 'Molimard M, Raherison C, Lignot S, Balestra A, Lamarque S, Chartier A, Droz-Perroteau C, Lassalle R, Moore N, Girodet PO. Chronic obstructive pulmonary disease exacerbation and inhaler device handling: real-life assessment of 2935 patients. Eur Respir J. 2017 Feb 15;49(2):1601794. doi: 10.1183/13993003.01794-2016. Print 2017 Feb.'}, {'pmid': '22878278', 'type': 'BACKGROUND', 'citation': 'Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.'}, {'pmid': '14513820', 'type': 'BACKGROUND', 'citation': 'Hess DR, Kallstrom TJ, Mottram CD, Myers TR, Sorenson HM, Vines DL; American Association for Respiratory Care. Care of the ventilator circuit and its relation to ventilator-associated pneumonia. Respir Care. 2003 Sep;48(9):869-79.'}, {'pmid': '11701099', 'type': 'BACKGROUND', 'citation': 'Brocklebank D, Ram F, Wright J, Barry P, Cates C, Davies L, Douglas G, Muers M, Smith D, White J. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. Health Technol Assess. 2001;5(26):1-149. doi: 10.3310/hta5260.'}, {'pmid': '20804428', 'type': 'BACKGROUND', 'citation': 'Rootmensen GN, van Keimpema AR, Jansen HM, de Haan RJ. Predictors of incorrect inhalation technique in patients with asthma or COPD: a study using a validated videotaped scoring method. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):323-8. doi: 10.1089/jamp.2009.0785.'}, {'pmid': '11822651', 'type': 'BACKGROUND', 'citation': 'Hesselink AE, Penninx BW, Wijnhoven HA, Kriegsman DM, van Eijk JT. Determinants of an incorrect inhalation technique in patients with asthma or COPD. Scand J Prim Health Care. 2001 Dec;19(4):255-60. doi: 10.1080/02813430152706792.'}, {'pmid': '7952549', 'type': 'BACKGROUND', 'citation': 'Goodman DE, Israel E, Rosenberg M, Johnston R, Weiss ST, Drazen JM. The influence of age, diagnosis, and gender on proper use of metered-dose inhalers. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1256-61. doi: 10.1164/ajrccm.150.5.7952549.'}, {'pmid': '9661680', 'type': 'BACKGROUND', 'citation': 'van Beerendonk I, Mesters I, Mudde AN, Tan TD. Assessment of the inhalation technique in outpatients with asthma or chronic obstructive pulmonary disease using a metered-dose inhaler or dry powder device. J Asthma. 1998;35(3):273-9. doi: 10.3109/02770909809068218.'}, {'pmid': '17267450', 'type': 'BACKGROUND', 'citation': 'Jarvis S, Ind PW, Shiner RJ. Inhaled therapy in elderly COPD patients; time for re-evaluation? Age Ageing. 2007 Mar;36(2):213-8. doi: 10.1093/ageing/afl174. Epub 2007 Jan 31.'}, {'pmid': '1290733', 'type': 'BACKGROUND', 'citation': 'Harvey J, Williams JG. Randomised cross-over comparison of five inhaler systems for bronchodilator therapy. Br J Clin Pract. 1992 Winter;46(4):249-51.'}, {'pmid': '8553275', 'type': 'BACKGROUND', 'citation': '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 Nov;50(11):1183-7. doi: 10.1136/thx.50.11.1183.'}, {'pmid': '22888221', 'type': 'BACKGROUND', 'citation': 'Yawn BP, Colice GL, Hodder R. Practical aspects of inhaler use in the management of chronic obstructive pulmonary disease in the primary care setting. Int J Chron Obstruct Pulmon Dis. 2012;7:495-502. doi: 10.2147/COPD.S32674. Epub 2012 Jul 25.'}, {'pmid': '25340245', 'type': 'BACKGROUND', 'citation': 'National Clinical Guideline Centre (UK). Chronic Kidney Disease (Partial Update): Early Identification and Management of Chronic Kidney Disease in Adults in Primary and Secondary Care. London: National Institute for Health and Care Excellence (UK); 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK248058/'}, {'pmid': '23967487', 'type': 'BACKGROUND', 'citation': 'Area de asma de SEPAR; Area de enfermeria de SEPAR; Departamento de asma ALAT. [SEPAR-ALAT consensus for inhaled therapies]. Arch Bronconeumol. 2013 Jun;49 Suppl 1:2-14. No abstract available. Spanish.'}, {'pmid': '24155355', 'type': 'BACKGROUND', 'citation': 'Myers TR. The science guiding selection of an aerosol delivery device. Respir Care. 2013 Nov;58(11):1963-73. doi: 10.4187/respcare.02812.'}, {'pmid': '22283582', 'type': 'BACKGROUND', 'citation': 'Capstick TG, Clifton IJ. Inhaler technique and training in people with chronic obstructive pulmonary disease and asthma. Expert Rev Respir Med. 2012 Feb;6(1):91-101; quiz 102-3. doi: 10.1586/ers.11.89.'}, {'pmid': '17392304', 'type': 'BACKGROUND', 'citation': 'Hendeles L, Colice GL, Meyer RJ. Withdrawal of albuterol inhalers containing chlorofluorocarbon propellants. N Engl J Med. 2007 Mar 29;356(13):1344-51. doi: 10.1056/NEJMra050380. No abstract available.'}, {'pmid': '10726183', 'type': 'BACKGROUND', 'citation': 'Giner J, Basualdo LV, Casan P, Hernandez C, Macian V, Martinez I, Mengibar A. [Guideline for the use of inhaled drugs. The Working Group of SEPAR: the Nursing Area of the Sociedad Espanola de Neumologia y Cirugia Toracica]. Arch Bronconeumol. 2000 Jan;36(1):34-43. doi: 10.1016/s0300-2896(15)30231-3. No abstract available. Spanish.'}, {'pmid': '11080609', 'type': 'BACKGROUND', 'citation': 'Pinto Pereira L, Clement Y, Simeon D. Educational intervention for correct pressurised metered dose inhaler technique in Trinidadian patients with asthma. Patient Educ Couns. 2001 Jan;42(1):91-7. doi: 10.1016/s0738-3991(00)00090-2.'}, {'pmid': '16441960', 'type': 'BACKGROUND', 'citation': 'Rau JL. Practical problems with aerosol therapy in COPD. Respir Care. 2006 Feb;51(2):158-72.'}, {'pmid': '10596686', 'type': 'BACKGROUND', 'citation': 'van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J. 1999 Nov;14(5):1034-7. doi: 10.1183/09031936.99.14510349.'}, {'pmid': '21448550', 'type': 'BACKGROUND', 'citation': 'McDonald VM, Higgins I, Simpson JL, Gibson PG. The importance of clinical management problems in older people with COPD and asthma: do patients and physicians agree? Prim Care Respir J. 2011 Dec;20(4):389-95. doi: 10.4104/pcrj.2011.00025.'}, {'pmid': '16185367', 'type': 'BACKGROUND', 'citation': 'Geller DE. Comparing clinical features of the nebulizer, metered-dose inhaler, and dry powder inhaler. Respir Care. 2005 Oct;50(10):1313-21; discussion 1321-2.'}, {'pmid': '17532698', 'type': 'BACKGROUND', 'citation': 'Melani AS, Bracci LS, Rossi M. Reduced Peak Inspiratory Effort through the Diskus((R)) and the Turbuhaler((R)) due to Mishandling is Common in Clinical Practice. Clin Drug Investig. 2005;25(8):543-9. doi: 10.2165/00044011-200525080-00007.'}, {'pmid': '15712814', 'type': 'BACKGROUND', 'citation': 'Georges CA, Bolton LB, Bennett C. Functional health literacy: an issue in African-American and other ethnic and racial communities. J Natl Black Nurses Assoc. 2004 Jul;15(1):1-4.'}, {'pmid': '16185371', 'type': 'BACKGROUND', 'citation': 'Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care. 2005 Oct;50(10):1360-74; discussion 1374-5.'}, {'pmid': '21367593', 'type': 'BACKGROUND', 'citation': 'Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.'}, {'pmid': '23098685', 'type': 'BACKGROUND', 'citation': 'Inhaler Error Steering Committee; Price D, Bosnic-Anticevich S, Briggs A, Chrystyn H, Rand C, Scheuch G, Bousquet J. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respir Med. 2013 Jan;107(1):37-46. doi: 10.1016/j.rmed.2012.09.017. Epub 2012 Oct 23.'}, {'pmid': '15654001', 'type': 'BACKGROUND', 'citation': 'Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.'}, {'pmid': '12468702', 'type': 'BACKGROUND', 'citation': 'Wright J, Brocklebank D, Ram F. Inhaler devices for the treatment of asthma and chronic obstructive airways disease (COPD). Qual Saf Health Care. 2002 Dec;11(4):376-82. doi: 10.1136/qhc.11.4.376.'}, {'pmid': '17923402', 'type': 'BACKGROUND', 'citation': 'Virchow JC, Crompton GK, Dal Negro R, Pedersen S, Magnan A, Seidenberg J, Barnes PJ. Importance of inhaler devices in the management of airway disease. Respir Med. 2008 Jan;102(1):10-9. doi: 10.1016/j.rmed.2007.07.031. Epub 2007 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the implementation of an education protocol and its impact on the correct inhalation technique in COPD patients presenting errors or mistakes. There will be 4 sessions, in each one the inhalation technique will be evaluated using a checklist of steps. Whenever errors are found, the correct use of each device will be educated through verbal explanation and written material will be delivered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD diagnosed by spirometry (presence of a postbronchodilator FEV1 / FVC ratio \\<0.7)\n* Over 40 years old\n* Use any of the following devices: metered dose inhaler, HandiHaler, Turbuhaler, Diskus, Aerolizer\n* Have at least one error in the inhalation technique\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Artificial airway\n* Cognitive impairment noted in the medical history\n* Hearing loss that complicates the compression of simple orders\n* Bilateral amaurosis\n* Functional dependence for the use of inhalers\n* Presence of abnormal movements in the upper limbs that interfere and / or impede the correct use of the devices'}, 'identificationModule': {'nctId': 'NCT03144557', 'briefTitle': 'Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Efficacy of an Education Protocol in the Correction of Inhalation Techniques in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '3064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Education protocol to correct inhalation technique', 'interventionNames': ['Other: Education']}], 'interventions': [{'name': 'Education', 'type': 'OTHER', 'description': 'Education protocol included 4 individual sessions of verbal and graphic instructions to correct inhalation technique in patients with COPD', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Guadalupe Gracia, PT-RT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}