NCT02660879

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

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

December 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

January 11, 2016

Last Update Submit

January 18, 2016

Conditions

Keywords

EducationInhaler

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Written Education

PLACEBO COMPARATOR

These patients were video taped before they had any inhaler education using their own inhalers. They were then given written educational materials, and given 5 minutes to read these materials. They were then re-taped for their inhaler technique.

Other: Written Document Educational Resource

Online Video Education

EXPERIMENTAL

These patients were video taped before they had any inhaler education using their own inhalers. They were then given online video education located at use-inhalers.com, and were asked to complete the education (took on average 5 minutes). They were then re-taped for their inhaler technique.

Other: Online Video Education

Interventions

A 2 page document with pictures discussing how to use an inhaler properly.

Written 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.

Online Video Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

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

    BACKGROUND
  • 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.

    PMID: 21249463BACKGROUND
  • 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.

    PMID: 18259998BACKGROUND
  • 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
  • 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.

    PMID: 23510684BACKGROUND
  • Cavender A, Alban M. Compulsory medical service in Ecuador: the physician's perspective. Soc Sci Med. 1998 Dec;47(12):1937-46. doi: 10.1016/s0277-9536(98)00335-9.

    PMID: 10075237BACKGROUND
  • Shah RF, Gupta RM. Video instruction is more effective than written instruction in improving inhaler technique. Pulm Pharmacol Ther. 2017 Oct;46:16-19. doi: 10.1016/j.pupt.2017.08.005. Epub 2017 Aug 7.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 21, 2016

Study Start

December 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 21, 2016

Record last verified: 2016-01