AsthmaE-TRaINNCT01426581
Effectiveness of Interventions to Teach Respiratory Inhaler Technique (E-TRaIN)
A study testing Teach-To-Goal and Brief Intervention in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Teach-To-Goal and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2013
- 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
- 18 years and older
- Admitting diagnosis of asthma or COPD
- Physician- diagnosed asthma, asthma/COPD, or COPD. We will enroll patients even if the primary reason for admission is not asthma or COPD (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible)
- Patient will be discharged home on a Metered Dose Inhaler (MDI; e.g., albuterol)
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
- Previous participant in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education.
Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction.
The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to retain instructions on respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices after discharge.
Read the detailed description
Respiratory inhalers are often used incorrectly by patients with obstructive lung disorders (including patients hospitalized with exacerbations of asthma or chronic obstructive pulmonary disease (COPD). As the mainstay of bronchodilator and anti-inflammatory therapy in patients with OLD, the implication of this difficulty with self-management is that patients are at risk for under-treatment and worse health outcomes. Several factors are thought to contribute to poor self-management skills, particularly inadequate patient education at healthcare encounters and inadequate patient health literacy. However, the most effective strategy to instruct patients about respiratory inhaler use in hospital settings is unclear, particularly in populations enriched with inadequate health literacy.
Therefore, the overall goal of this study is to evaluate the relative effectiveness of two hospital-based educational interventions: Teach-To-Goal (TTG, iterative cycles of demonstration-based education and assessment) versus Brief Intervention (BI, one-time set of verbal instructions) on the durability of instructions provided in the hospital and its effect on clinical outcomes (e.g., respiratory events and/or death), post hospital discharge. The investigators also plan to evaluate whether the relative effectiveness of TTG vs. BI varies by level of health literacy. The objectives of this proposal are to conduct a study in adults hospitalized with asthma/COPD to 1) to evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI and Diskus® devices after discharge home and 2) To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy compared to those with adequate health literacy. These data will inform the development of a larger, multi-center clinical trial.
- Being tested
- Teach-To-Goal, Brief Intervention
- Keywords
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Chronic Obstructive, Lung Disease, Obstructive, Self-management, Health Literacy
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-To-GoalBehavioural
Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
Brief InterventionBehavioural
Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention A | Experimental | Intervention: Teach to Goal Receives: Behavioral: Teach-To-Goal |
| Educational Intervention B: | Experimental | Brief Intervention Receives: Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge
To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home.
Measured: 1 month
Secondary outcomes (4)
Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events
To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy using self-reported acute-care events 30 days post discharge. To measure less-than-adequate health literacy, the investigators administered the Short Test of Functional Health Literacy in Adults, a validated tool to assess whether a participant has adequate, marginal, or inadequate health literacy. Less-than-adequate included marginal and inadequate health literacy.
Measured: 1 month
Number of Participants With Self-Efficacy
This is a self-reported measure of how confident a participant is on how well they use their metered dose inhaler.
Measured: 1 month
Symptom Control
Symptom control will be assessed using interviewer-administered surveys. Using the Borg Dyspnea Scale, a validated Scale from 0 - 20 where 20 is maximal dyspnea, we took the difference between the the 30 day follow-up self reported shortness of breath from baseline to see if there was improvement in symptom control.
Measured: 1 month
Number of Participants With Acute Care Events 30 Days Post Discharge
Exacerbation/acute care events within one month of hospital discharge
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionFeb 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 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
- NCT01426581
- Sponsor's protocol ID
- 11-0248
- Acronym
- E-TRaIN
- Status last verified
- Oct 2019
- First submitted
- 29 Aug 2011
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Press VG, Arora VM, Trela KC, Adhikari R, Zadravecz FJ, Liao C, Naureckas E, White SR, Meltzer DO, Krishnan JA. Effectiveness of Interventions to Teach Metered-Dose and Diskus Inhaler Techniques. A Randomized Trial. Ann Am Thorac Soc. 2016 Jun;13(6):816-24. doi: 10.1513/AnnalsATS.201509-603OC.
PubMed 26998961
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interventions to Teach Respiratory Inhaler techNique (E-TRaIN)
- ClinicalTrials.gov ID
- NCT01426581
- Acronym / sponsor ID
- E-TRaIN / 11-0248
- Keywords
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease, Chronic Obstructive, Lung Disease, Obstructive, Self-management, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 29 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education.
Teach-to-Goal (TTG) education employs instruction followed by patient "teach-back," then repeated cycles of learning and assessment until a skill is mastered. By contrast, Brief Intervention (BI) education only consists of providing the patient with verbal and written instruction.
The investigators hypothesize that hospital-based TTG compared to BI increases a patient's ability to retain instructions on respiratory inhaler technique. The investigators will test this hypothesis separately for the MDI and Diskus® devices after discharge.
Detailed description
Respiratory inhalers are often used incorrectly by patients with obstructive lung disorders (including patients hospitalized with exacerbations of asthma or chronic obstructive pulmonary disease (COPD). As the mainstay of bronchodilator and anti-inflammatory therapy in patients with OLD, the implication of this difficulty with self-management is that patients are at risk for under-treatment and worse health outcomes. Several factors are thought to contribute to poor self-management skills, particularly inadequate patient education at healthcare encounters and inadequate patient health literacy. However, the most effective strategy to instruct patients about respiratory inhaler use in hospital settings is unclear, particularly in populations enriched with inadequate health literacy.
Therefore, the overall goal of this study is to evaluate the relative effectiveness of two hospital-based educational interventions: Teach-To-Goal (TTG, iterative cycles of demonstration-based education and assessment) versus Brief Intervention (BI, one-time set of verbal instructions) on the durability of instructions provided in the hospital and its effect on clinical outcomes (e.g., respiratory events and/or death), post hospital discharge. The investigators also plan to evaluate whether the relative effectiveness of TTG vs. BI varies by level of health literacy. The objectives of this proposal are to conduct a study in adults hospitalized with asthma/COPD to 1) to evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI and Diskus® devices after discharge home and 2) To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy compared to those with adequate health literacy. These data will inform the development of a larger, multi-center clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention A | Experimental | Behavioral: Teach-To-GoalIntervention: Teach to Goal |
| Educational Intervention B: | Experimental | Behavioral: Brief InterventionBrief Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Admitting diagnosis of asthma or COPD
- Physician- diagnosed asthma, asthma/COPD, or COPD. We will enroll patients even if the primary reason for admission is not asthma or COPD (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible)
- Patient will be discharged home on a Metered Dose Inhaler (MDI; e.g., albuterol)
Key exclusion criteria (4 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
- Previous participant in this study
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 |
|---|---|---|
| Teach-To-GoalParticipants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback" or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) | Behavioural | Educational Intervention A |
| Brief InterventionParticipants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions) | Behavioural | Educational Intervention B: |
Primary outcome
Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge
Time frame: 1 month
To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home.
4 secondary outcomes
Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events
Time frame: 1 month
Number of Participants With Self-Efficacy
Time frame: 1 month
Symptom Control
Time frame: 1 month
Number of Participants With Acute Care Events 30 Days Post Discharge
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26998961Press VG, Arora VM, Trela KC, Adhikari R, Zadravecz FJ, Liao C, Naureckas E, White SR, Meltzer DO, Krishnan JA. Effectiveness of Interventions to Teach Metered-Dose and Diskus Inhaler Techniques. A Randomized Trial. Ann Am Thorac Soc. 2016 Jun;13(6):816-24. doi: 10.1513/AnnalsATS.201509-603OC.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-To-Goal and Brief Intervention in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by University of Chicago at 1 site in United States.
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 4 inclusion and 4 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 29 Oct 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?
Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (time frame: 1 month). 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 NCT01426581, which also lists 1 linked publication.
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 19 Nov 2019.