NCT03144557

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

May 2, 2017

Last Update Submit

May 4, 2017

Conditions

Keywords

EducationCOPDInhalation Devices

Outcome Measures

Primary Outcomes (1)

  • Changes in the inhalation technique

    If the patient that presented errors or mistakes corrected inhalation technique

    Baseline and every session (48-72 hours)

Secondary Outcomes (3)

  • Type of error

    Baseline

  • Inhalation device

    Baseline

  • Patient's characteristics

    Baseline

Study Arms (1)

Intervention

EXPERIMENTAL

Education protocol to correct inhalation technique

Other: Education

Interventions

Education protocol included 4 individual sessions of verbal and graphic instructions to correct inhalation technique in patients with COPD

Intervention

Eligibility Criteria

Age40 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with COPD diagnosed by spirometry (presence of a postbronchodilator FEV1 / FVC ratio \<0.7)
  • Over 40 years old
  • Use any of the following devices: metered dose inhaler, HandiHaler, Turbuhaler, Diskus, Aerolizer
  • Have at least one error in the inhalation technique
  • Signature of informed consent.

You may not qualify if:

  • Artificial airway
  • Cognitive impairment noted in the medical history
  • Hearing loss that complicates the compression of simple orders
  • Bilateral amaurosis
  • Functional dependence for the use of inhalers
  • Presence of abnormal movements in the upper limbs that interfere and / or impede the correct use of the devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Related Publications (31)

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    PMID: 11701099BACKGROUND
  • 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: 20804428BACKGROUND
  • 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: 11822651BACKGROUND
  • 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: 7952549BACKGROUND
  • 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: 9661680BACKGROUND
  • 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: 17267450BACKGROUND
  • 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: 1290733BACKGROUND
  • 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: 8553275BACKGROUND
  • 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: 22888221BACKGROUND
  • 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: 25340245BACKGROUND
  • 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: 23967487BACKGROUND
  • 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: 24155355BACKGROUND
  • 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: 22283582BACKGROUND
  • 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: 17392304BACKGROUND
  • 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: 10726183BACKGROUND
  • 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: 11080609BACKGROUND
  • Rau JL. Practical problems with aerosol therapy in COPD. Respir Care. 2006 Feb;51(2):158-72.

    PMID: 16441960BACKGROUND
  • 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: 10596686BACKGROUND
  • 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: 21448550BACKGROUND
  • 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: 16185367BACKGROUND
  • 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: 17532698BACKGROUND
  • 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: 15712814BACKGROUND
  • 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: 16185371BACKGROUND
  • 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: 21367593BACKGROUND
  • 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: 23098685BACKGROUND
  • 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: 15654001BACKGROUND
  • 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: 12468702BACKGROUND
  • 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.

    PMID: 17923402BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Guadalupe Gracia, PT-RT

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 9, 2017

Study Start

January 2, 2017

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations