Chronic Obstructive Pulmonary DiseaseNCT02278237
Pre/Post Pilot Test of Video Module Education
A study testing VME Group in people with Chronic Obstructive Pulmonary Disease and Asthma, run by University of Chicago.
Trial summary
Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million hospitalizations in the United States annually and COPD is the third leading cause of 30-day re-hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- What is being tested?
- VME Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Admission to the inpatient medical service and surgical service
- Physician-diagnosed COPD or asthma. We will enroll patients even if the primary reason for admission is not COPD or asthma (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible).
Who cannot join
- Currently in an intensive care unit
- Physician declines to provide consent
- Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
About this study
Official title: Pre/Post Pilot Test of VME for the Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN Study
Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million hospitalizations in the United States annually and COPD is the third leading cause of 30-day re-hospitalizations. Clinical trials have established the efficacy of treatments primarily dispensed via respiratory inhaler devices that reduce morbidity and health care utilization if they are used correctly. The effectiveness of these medications in real-world settings is limited by the fact that patients often do not use inhalers correctly. Current guidelines recommend assessing and teaching inhaler technique at all health care encounters, including hospitalization. Over 75% of hospitalized patients in an urban, predominantly underserved population misused their respiratory inhalers, highlighting a missed opportunity to educate these patients with high potential to benefit. Hospitalization, therefore, provides a potential 'teachable moment' to correct this misuse. My preliminary data indicate that one strategy, in-person teach-to-goal (TTG), is effective in teaching hospitalized patients proper inhaler technique and is more effective than simple verbal instruction. While TTG is a promising, several limitations prevent widespread adoption. TTG is time-consuming and costly. Also, reinforcement may be needed, which may be impractical with in-person TTG. One potential method to surmount TTG's limitations is use of interactive video module education (VME) that has the potential to be less costly, maintain fidelity, and be more easily extended into the post-discharge setting than in-person TTG. Before widespread implementation of VME, it is critical to rigorously develop and test VME for inhaler education in the hospital setting. Ultimately, it will also be important to understand patients' ability and willingness to use post-discharge VME for educational reinforcement to allow for this strategy to transition patients across care settings from hospital to home.
We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or COPD.
For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler technique prior to implementing a larger RCT to test the comparative effectiveness of VME versus TTG.
Read the detailed description
The specific aim to test this hypothesis is:
To iteratively test VME to teach correct use of metered dose inhaler (MDIs) and dry-powder Diskus® devices to hospitalized patients with Asthma or COPD. We partnered with software development companies to develop VME modules that (self)-assess and teach respiratory inhaler technique to hospitalized participants. We have tested the VME in focus groups. Now that the VME is developed we will iteratively pilot test (n=30-40) the VME strategy (up to 3 rounds (90-120 total)) to obtain important patient feedback,preferences and preliminary efficacy estimates for the module.
We hypothesize that participants' post-VME inhaler technique will be significantly better than their pre-VME inhaler technique.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Being tested
- VME Group
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VME GroupBehavioural
Also called Video Module Education (VME)
Received inhaler education through VME (virtual education module)
| Study group | Role | What they receive |
|---|---|---|
| VME Group | Experimental | Pre and post VME education group. The Intervention is the use of the virtual education module rather than the interpersonal educational strategy. Receives: Behavioral: VME Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Inhaler Misuse Pre- and Post-VME
Assess patient's inhaler technique using Inhaler checklists by the trained assessor.
The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit
We will define inhaler technique in two ways:
- Correct Use (i.e., >75% of steps correct)
- Mastery (i.e., perfect technique, 100% steps correct)
Measured: Up to 30 days
Secondary outcomes (3)
Symptom Burden
Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information.
Measured: up to 30 days
Quality of Life (QOL)
Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
Measured: up to 30 days
Self-efficacy of Inhaler Technique
Assess patient's confidence in using their inhalers.
We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly".
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie G. Press, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278237
- Sponsor's protocol ID
- IRB12-1844
- Status last verified
- Feb 2019
- First submitted
- 10 Oct 2014
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre/Post Pilot Test of VME for the Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN Study
- ClinicalTrials.gov ID
- NCT02278237
- Acronym / sponsor ID
- IRB12-1844
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million hospitalizations in the United States annually and COPD is the third leading cause of 30-day re-hospitalizations. Clinical trials have established the efficacy of treatments primarily dispensed via respiratory inhaler devices that reduce morbidity and health care utilization if they are used correctly. The effectiveness of these medications in real-world settings is limited by the fact that patients often do not use inhalers correctly. Current guidelines recommend assessing and teaching inhaler technique at all health care encounters, including hospitalization. Over 75% of hospitalized patients in an urban, predominantly underserved population misused their respiratory inhalers, highlighting a missed opportunity to educate these patients with high potential to benefit. Hospitalization, therefore, provides a potential 'teachable moment' to correct this misuse. My preliminary data indicate that one strategy, in-person teach-to-goal (TTG), is effective in teaching hospitalized patients proper inhaler technique and is more effective than simple verbal instruction. While TTG is a promising, several limitations prevent widespread adoption. TTG is time-consuming and costly. Also, reinforcement may be needed, which may be impractical with in-person TTG. One potential method to surmount TTG's limitations is use of interactive video module education (VME) that has the potential to be less costly, maintain fidelity, and be more easily extended into the post-discharge setting than in-person TTG. Before widespread implementation of VME, it is critical to rigorously develop and test VME for inhaler education in the hospital setting. Ultimately, it will also be important to understand patients' ability and willingness to use post-discharge VME for educational reinforcement to allow for this strategy to transition patients across care settings from hospital to home.
We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or COPD.
For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler technique prior to implementing a larger RCT to test the comparative effectiveness of VME versus TTG.
Detailed description
The specific aim to test this hypothesis is:
To iteratively test VME to teach correct use of metered dose inhaler (MDIs) and dry-powder Diskus® devices to hospitalized patients with Asthma or COPD. We partnered with software development companies to develop VME modules that (self)-assess and teach respiratory inhaler technique to hospitalized participants. We have tested the VME in focus groups. Now that the VME is developed we will iteratively pilot test (n=30-40) the VME strategy (up to 3 rounds (90-120 total)) to obtain important patient feedback,preferences and preliminary efficacy estimates for the module.
We hypothesize that participants' post-VME inhaler technique will be significantly better than their pre-VME inhaler technique.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VME Group | Experimental | Behavioral: VME GroupPre and post VME education group. The Intervention is the use of the virtual education module rather than the interpersonal educational strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Admission to the inpatient medical service and surgical service
- Physician-diagnosed COPD or asthma. We will enroll patients even if the primary reason for admission is not COPD or asthma (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible).
Key exclusion criteria (3 listed)
- Currently in an intensive care unit
- Physician declines to provide consent
- Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
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 |
|---|---|---|
| VME GroupAlso: Video Module Education (VME)Received inhaler education through VME (virtual education module) | Behavioural | VME Group |
Primary outcome
Number of Participants With Inhaler Misuse Pre- and Post-VME
Time frame: Up to 30 days
Assess patient's inhaler technique using Inhaler checklists by the trained assessor. The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit We will define inhaler technique in two ways: 1. Correct Use (i.e., >75% of steps correct) 2. Mastery (i.e., perfect technique, 100% steps correct)
3 secondary outcomes
Symptom Burden
Time frame: up to 30 days
Quality of Life (QOL)
Time frame: up to 30 days
Self-efficacy of Inhaler Technique
Time frame: up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Valerie G. Press, MD, MPH principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing VME Group in people with Chronic Obstructive Pulmonary Disease and Asthma, run by University of Chicago.
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 3 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 4 Jun 2019. 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. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Inhaler Misuse Pre- and Post-VME (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2019.