- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660879
The Effect of Video Education on Inhaler Use Technique (InhalerEdu)
January 18, 2016 updated by: Romil Fenil Shah
The Effect of Video Education on Improving Inhaler Use Technique
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Written Education
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.
|
A 2 page document with pictures discussing how to use an inhaler properly.
|
Experimental: Online Video Education
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in Inhaler Technique Defined by 11 point rubric which details steps and techniques necessary for proper inhaler use
Time Frame: 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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].
- 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.
- 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.
- 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.
- 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.
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
January 11, 2016
First Submitted That Met QC Criteria
January 18, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Estimate)
January 21, 2016
Last Update Submitted That Met QC Criteria
January 18, 2016
Last Verified
January 1, 2016
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nebulizers and Vaporizers
-
Inhalation Sciences Sweden ABCTC Clinical Trial Consultants AB; Pharm-Analyt Labor GmbH; PlantVision ABCompletedNebulizers and VaporizersSweden
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingAdult Fathers and Mothers | Children and Adolescents, Boys and GirlsBrazil
-
Smith & Nephew, Inc.WithdrawnWounds and InjuriesUnited States
-
Arava Bio Tech Ltd.UnknownWounds | Other Ulcers Wounds and Skin ProblemsIsrael
-
Arthrex, Inc.RecruitingDegenerative and Traumatic Pathology of the Knee | Degenerative and Traumatic Pathology of the Shoulder and Elbow | Degenerative and Traumatic Pathology of the Foot and Ankle | Degenerative and Traumatic Pathology of the Hand and Wrist | Degenerative and Traumatic Pathology of the HipUnited States, United Kingdom, Canada, Puerto Rico, South Africa
-
Centre Francois BaclesseMinistry of Health, FranceCompleted
-
Shanghai Children's Medical CenterNot yet recruitingTo Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy
-
Centro Cardiologico MonzinoUnknown
-
International Centre for Diarrhoeal Disease Research...Population Council; Marie Stopes International; Bangladesh Legal Aid and Services... and other collaboratorsCompletedSexual and Reproductive Health and Rights | Violence Against Women and Girls
Clinical Trials on Written Document Educational Resource
-
Universidad de GranadaNot yet recruitingAsthma | Allergy
-
Boston Medical CenterCompleted
-
Mayo ClinicMountain Park Health CenterActive, not recruiting
-
University Hospital, Clermont-FerrandInnovatherm; Clermont CommunautéCompletedPhysical Activity | Knee Osteoarthritis | Exercise | Education | Self-managementFrance
-
Ariel UniversityCompleted
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedSkin Carcinoma | Skin MelanomaUnited States
-
University of Alabama at BirminghamProcter and GambleCompleted
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR); York UniversityUnknownColorectal Cancer | Sexual DysfunctionCanada
-
University Hospital, GrenobleCompletedPost Traumatic Stress DisorderFrance