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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02660879
Other study ID # STU00087922
Secondary ID
Status Completed
Phase N/A
First received January 11, 2016
Last updated January 18, 2016
Start date December 2013
Est. completion date January 2014

Study information

Verified date January 2016
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators looked at the effect that video instruction located at www.useinhalers.com would have on improving inhaler technique at a hospital in Guayaquil, Ecuador. The investigators compared this video instruction to written Spanish inhaler education. The investigators video taped participants before and after the intervention, and graded their technique on a pre-defined rubric.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinically-stable outpatient adults (=18 years) with Asthma or Chronic Obstructive Pulmonary Disease (COPD) with history of at least one exacerbation in last 1 year

- Clinical diagnoses of asthma or COPD

Exclusion Criteria:

- Patients with language barrier (unable to understand and communicate in either English or Spanish)

- Cognitive or physical dysfunction that, in the investigator's opinion, would interfere with completion of the study

- Significant co-morbidity that can confound asthma symptoms - e.g. Congestive Heart Failure, current smoker, uncontrolled Gastroesophageal Reflux Disease, neuromuscular disease, chest wall deformity

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Written Document Educational Resource
A 2 page document with pictures discussing how to use an inhaler properly.
Online Video Education
Education which included step-by-step instruction on how to use their inhalers correctly as well as a webcam element that allowed users to see themselves practice their inhalers along with actors on screen.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Romil Fenil Shah Northwestern University

References & Publications (6)

Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih S, Halwani R, Al-Muhsen S. Improper inhaler technique is associated with poor asthma control and frequent emergency department visits. Allergy Asthma Clin Immunol. 2013 Mar 6;9(1):8. doi: 10.1186/1710-1492-9-8. — View Citation

Cavender A, Albán M. Compulsory medical service in Ecuador: the physician's perspective. Soc Sci Med. 1998 Dec;47(12):1937-46. — View 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. Review. — View Citation

Hagmolen of ten Have W, van de Berg NJ, Bindels PJ, van Aalderen WM, van der Palen J. Assessment of inhalation technique in children in general practice: increased risk of incorrect performance with new device. J Asthma. 2008 Jan-Feb;45(1):67-71. doi: 10.1080/02770900701815834. — View Citation

http://www.cdc.gov/VitalSigns/Asthma (accessed: 28 July 2012)

Press VG, Arora VM, Shah LM, Lewis SL, Ivy K, Charbeneau J, Badlani S, Nareckas E, Mazurek A, Krishnan JA. Misuse of respiratory inhalers in hospitalized patients with asthma or COPD. J Gen Intern Med. 2011 Jun;26(6):635-42. doi: 10.1007/s11606-010-1624-2. Epub 2011 Jan 20. Erratum in: J Gen Intern Med. 2011 Apr;26(4):458. Naurekas, Edward [corrected to Nareckas, Edward]. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in Inhaler Technique Defined by 11 point rubric which details steps and techniques necessary for proper inhaler use Videos taken before educational interventions and directly after the 5-10 minutes allotted for the educational intervention. Videos will be assessed in the following months after using the 11 point rubric. No
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