Nebulizers and VaporizersInhalerEduNCT02660879
The Effect of Video Education on Inhaler Use Technique
A study testing Written Document Educational Resource and Online Video Education in people with Nebulizers and Vaporizers and Patient Education, run by Romil Fenil Shah.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nebulizers and Vaporizers, Patient Education, E Learning
- What is being tested?
- Written Document Educational Resource and Online Video Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jan 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Nebulizers and Vaporizers, Patient Education, E Learning
- Being tested
- Written Document Educational Resource, Online Video Education
- Keywords
- Education, Inhaler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Document Educational ResourceOther
A 2 page document with pictures discussing how to use an inhaler properly.
Online Video EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Online Video Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Inhaler Technique Defined by 11 point rubric which details steps and techniques necessary for proper inhaler use
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nebulizers and VaporizersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romil Fenil Shah
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor-investigator, Romil Fenil Shah, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660879
- Sponsor's protocol ID
- STU00087922
- Acronym
- InhalerEdu
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21249463Hagmolen 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.
PubMed 18259998Fink 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.
PubMed 16185371Al-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.
PubMed 23510684Cavender 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.
PubMed 10075237Shah 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.
PubMed 28797611
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Education on Improving Inhaler Use Technique
- ClinicalTrials.gov ID
- NCT02660879
- Acronym / sponsor ID
- InhalerEdu / STU00087922
- Conditions
- Nebulizers and Vaporizers, Patient Education, E Learning
- Keywords
- Education, Inhaler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Romil Fenil ShahUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Education | Placebo comparator | Other: Written Document Educational ResourceThese 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. |
| Online Video Education | Experimental | Other: Online Video EducationThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Document Educational ResourceA 2 page document with pictures discussing how to use an inhaler properly. | Other | Written Education |
| Online Video EducationEducation 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. | Other | Online Video Education |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Backgroundhttp://www.cdc.gov/VitalSigns/Asthma (accessed: 28 July 2012)
- Background: PubMed 21249463Press 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.
- Background: PubMed 18259998Hagmolen 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.
- Background: PubMed 16185371Fink 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.
- Background: PubMed 23510684Al-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.
- Background: PubMed 10075237Cavender 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.
- Derived from this study: PubMed 28797611Shah 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Written Document Educational Resource and Online Video Education in people with Nebulizers and Vaporizers and Patient Education, run by Romil Fenil Shah.
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 2 inclusion and 3 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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.). 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 NCT02660879, which also lists 7 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 21 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.