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AzTrials

COPDNCT03144557

Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD

A study testing Education in people with COPD and Education, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD, Education
What is being tested?
Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteArgentina
Study dates
2 Jan 2017to 30 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

Other trials in Argentina

About this study

Official title: Efficacy of an Education Protocol in the Correction of Inhalation Techniques in Patients With Chronic Obstructive Pulmonary Disease

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.

Conditions
COPD, Education
Being tested
Education
Keywords
Education, COPD, Inhalation Devices
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationOther

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

Study groups in NCT03144557
Study groupRoleWhat they receive
InterventionExperimentalEducation protocol to correct inhalation technique
Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the inhalation technique

    If the patient that presented errors or mistakes corrected inhalation technique

    Measured: Baseline and every session (48-72 hours)

Secondary outcomes (3)

  1. Type of error

    Frequent errors in inhalation technique using different inhaler devices

    Measured: Baseline

  2. Inhalation device

    Inhaler that presents the greatest number of mistakes

    Measured: Baseline

  3. Patient's characteristics

    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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start2 Jan 2017
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144557
Sponsor's protocol ID
3064
Status last verified
May 2017
First submitted
2 May 2017
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28182569

  • 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.

    PubMed 22878278

  • 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.

    PubMed 14513820

  • 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.

    PubMed 11701099

  • 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.

    PubMed 20804428

  • 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.

    PubMed 11822651

  • 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.

    PubMed 7952549

  • 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.

    PubMed 9661680

  • 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.

    PubMed 17267450

  • 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.

    PubMed 1290733

  • 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.

    PubMed 8553275

  • 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.

    PubMed 22888221

  • 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/

    PubMed 25340245

  • 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.

    PubMed 23967487

  • Myers TR. The science guiding selection of an aerosol delivery device. Respir Care. 2013 Nov;58(11):1963-73. doi: 10.4187/respcare.02812.

    PubMed 24155355

Questions about this trial

What is this clinical trial studying?

A study testing Education in people with COPD and Education, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the inhalation technique (time frame: Baseline and every session (48-72 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03144557, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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