COPDNCT05664347
Video-based Teach-to-goal Intervention on Inhaler Technique on Jordanian Adults With Asthma and COPD
A study testing Verbal teach to goal education and Video based teach to goal education in people with COPD and Asthma, run by University of Jordan at 1 site in Jordan.
Trial summary
This study was an interventional educational study that was intended to find out the effect of a video based inhaler technique education on improving inhaler technique mastery, disease control, medication adherence and patient quality of life in comparison to verbal education among adults with asthma or COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, Asthma, Inhaled Steroid Dependent Asthma
- What is being tested?
- Verbal teach to goal education and Video based teach to goal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteJordan
- Study dates
- 9 Mar 2020to 21 Feb 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of Asthma or COPD.
- Started on one or more inhaler devices for a minimum of one month.
- Expected to continue using their inhaler devices chronically.
Who cannot join
- Patients at high risk of infection (immunocompromised).
- Patients presenting with a very severe clinical presentation (severe dyspnoea, confusion due to hypoxemia, the need for continuous oxygen therapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video-based Teach-to-goal Intervention on Inhaler Technique on Adults With Asthma and COPD: a Randomized Controlled Trial
This study was an interventional educational study that was intended to find out the effect of a video based inhaler technique education on improving inhaler technique mastery, disease control, medication adherence and patient quality of life in comparison to verbal education among adults with asthma or COPD.
- Conditions
- COPD, Asthma, Inhaled Steroid Dependent Asthma
- Being tested
- Verbal teach to goal education, Video based teach to goal education
- Keywords
- Video-Based, Teach To Goal Education, Chronic Obstructive Pulmonary Disease, Asthma, Randomized Controlled Trial, Patient Education, Quality of Life, Medication adherence, Inhaler technique
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal teach to goal educationBehavioural
Also called verbal TTG
Participants were showed how to use correctly their inhalers and then asked again to show the technique. For each incorrect step, the patients were corrected and asked to repeat the steps until they mastered the technique. This process was repeated a maximum of three times.
Video based teach to goal educationBehavioural
Also called video-based TTG
Participants were educated by the a video-based teach to goal method. using a smartphone, an educational video illustrating the correct technique for each of the inhalers used by the patient was displayed. After watching the video, the patients were asked to show again how to use their inhaler and for each wrong step the video was displayed again until mastering the correct technique a maximum of three times. At the end of the interview participants in the intervention group received a copy of the video via WhatsApp and were all invited to watch the video whenever needed.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard verbal teach to goal inhaler technique education Receives: Behavioral: Verbal teach to goal education |
| Intervention | Active comparator | Video based teach to goal inhaler technique education Receives: Behavioral: Video based teach to goal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with correct Inhaler technique
The ability of the participants to use their inhaler devices correctly: using standardized checklists
Measured: At base line "first interview"
Number of participants with correct Inhaler technique
The ability of the participants to use their inhaler devices correctly: using standardized checklists
Measured: After three months of intervention "second interview"
Secondary outcomes (10)
Number of participants with moderate-high medication adherence
Adherence to inhaled medications used for the management of Asthma or COPD using morisky-green levien scale (MGLS). This scale is a 4 point previously validated score for the assessment of medication adherence, increase in score from 1 to 4 means better medication adherence. patients with a MGLS of 1 were considered to have low medication adherence while those with a score that is equal or higher than 2 were considered to have moderate-high level of adherence.
Measured: At base line "first interview"
Number of participants with moderate-high medication adherence
Adherence to inhaled medications used for the management of Asthma or COPD using morisky-green levien scale (MGLS). This scale is a 4 point previously validated score for the assessment of medication adherence, increase in score from 1 to 4 means better medication adherence. patients with a MGLS of 1 were considered to have low medication adherence while those with a score that is equal or higher than 2 were considered to have moderate-high level of adherence.
Measured: After Three months of intervention "second interview"
Number of asthmatic patients with well-controlled Disease
Assessment of symptom frequency and severity using the Asthma control test (ACT). a scale of 25 points, the minimum score is 5 points which indicates the worst symptom control while the maximum score "best disease control" is indicated by the score of 25.
Patients with a score of 5-19 were considered having uncontrolled asthma while those with a score of 20-25 had a well controlled asthma.
Measured: At base line "first interview"
Number of asthmatic patients with well-controlled Disease
Assessment of symptom frequency and severity using the Asthma control test (ACT). a scale of 25 points, the minimum score is 5 points which indicates the worst symptom control while the maximum score "best disease control" is indicated by the score of 25.
Patients with a score of 5-19 were considered having uncontrolled asthma while those with a score of 20-25 had a well controlled asthma.
Measured: After Three months of intervention "second interview"
Number of COPD patients with well-controlled Disease
Assessment of symptom frequency and severity using the COPD assessment test. a scale of 40 points; disease control is considered better as the score decreases. participants with scores of 0-9 were considered having less symptoms "well controlled COPD" while those with a score between 10-40 were considered having more symptoms "less controlled COPD".
Measured: At base line "first interview"
Number of COPD patients with well-controlled Disease
Assessment of symptom frequency and severity using the COPD assessment test. a scale of 40 points; disease control is considered better as the score decreases. participants with scores of 0-9 were considered having less symptoms "well controlled COPD" while those with a score between 10-40 were considered having more symptoms "less controlled COPD".
Measured: After Three months of intervention "second interview"
Asthma related quality of life
Assessment of asthmatic patients quality of life using the mini asthma quality of life questionnaire (mini-AQLQ). A 15 questions scale with a score of 1-7 for each question. average score was calculated to give a result between 1-7. as the average score increased from 1-7 the disease related quality of life was considered better;
- total impairment
- highly impaired
- very impaired
- moderately impaired
- somehow impaired
- little impairment
- no impairment.
Measured: At base line "first interview"
Asthma related quality of life
Assessment of asthmatic patients quality of life using the mini asthma quality of life questionnaire (mini-AQLQ). A 15 questions scale with a score of 1-7 for each question. average score was calculated to give a result between 1-7. as the average score increased from 1-7 the disease related quality of life was considered better;
- total impairment
- highly impaired
- very impaired
- moderately impaired
- somehow impaired
- little impairment
- no impairment.
Measured: After Three months of intervention "second interview"
COPD related quality of life
Assessment of COPD patients quality of life using the St.George respiratory questionnaire.
a 50-item validated tool. Each question had a specific weight assigned by the developer and the SGRQ scores are calculated using an automated application that was also designed and afforded by the questionnaire developer.
The automated application can thus produce four final results; a total score that represents the total burden of COPD on the patient's quality of life, a 'symptom' score, an 'activity limitation' score and an 'impact' score.
The total SGRQ score and the score for each of the three domains can range from 0 to 100, where an increase in the score indicates more impairment exerted by the disease on the patient's QoL.
Measured: At base line "first interview"
COPD related quality of life
Assessment of COPD patients quality of life using the St.George respiratory questionnaire.
a 50-item validated tool. Each question had a specific weight assigned by the developer and the SGRQ scores are calculated using an automated application that was also designed and afforded by the questionnaire developer.
The automated application can thus produce four final results; a total score that represents the total burden of COPD on the patient's quality of life, a 'symptom' score, an 'activity limitation' score and an 'impact' score.
The total SGRQ score and the score for each of the three domains can range from 0 to 100, where an increase in the score indicates more impairment exerted by the disease on the patient's QoL.
Measured: After Three months of intervention "second interview"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start9 Mar 2020
- Primary completion21 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with asthma or COPD, who were started on any inhaler for a minimum of one month and will continue using them chronically were met in the JUH respiratory clinic and invited to participate. Patients at high risk for infection, or those presenting with a very severe clinical presentation were excluded. Taking into account the non-invasive nature of the educational intervention, and the need to reduce the risk of spread of COVID19 virus (sharing pens or papers), a verbal consent was obtained. Enrolled participants were randomized using simple randomization into two groups; odd numbers for the control group (received a verbal TTG education on their inhaler technique) and even numbers for the intervention group ( received a video based TTG education). The primary and secondary outcomes of the study were inhaler technique mastery, amelioration of disease control, disease related quality of life and medication adherence at follow-up (after 3 months).
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oriana Awwad, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664347
- Sponsor's protocol ID
- 124454
- Status last verified
- Dec 2022
- First submitted
- 30 Sep 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
G.I.f.C.O.L.D. (GOLD), Global Strategy for the Diagnosis, Managment, and Prevention of Chronic Obstructive Pulmonary Disease, 2020. https://goldcopd.org/gold-reports/. (Accessed November 11, 2019.
G.I.f.A. (GINA), Global Strategy for Ashtma Managment and Prevention, 2021. https://ginasthma.org/gina-reports/. (Accessed June 15, 2021.
W.H.O. WHO, Chronic Obstructive Pulmonary Disease (COPD) 2017. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd). (Accessed January, 22 2020.
W.H.O. WHO, Asthma, 2020. https://www.who.int/news-room/q-a-detail/asthma. (Accessed May, 24 2020.
European Respiratory Society, The Global Impact of Respiratory Disease, Sheffield, 2017.
The global asthma report (GAR), The Burden of Asthma, 2018. http://www.globalasthmareport.org/burden/mortality.php. (Accessed February, 18 2020.
Lokke A, Lange P, Lykkegaard J, Ibsen R, Andersson M, de Fine Licht S, Hilberg O. Economic Burden of COPD by Disease Severity - A Nationwide Cohort Study in Denmark. Int J Chron Obstruct Pulmon Dis. 2021 Mar 10;16:603-613. doi: 10.2147/COPD.S295388. eCollection 2021.
PubMed 33731990C.f.D.C.a.P. CDC, Chronic obstructive pulmonary disease (COPD), 2021. https://www.cdc.gov/copd/infographics/copd-costs.html. (Accessed Jan, 11 2021 2021).
Abu-Ekteish F, Otoom S, Shehabi I. Prevalence of asthma in Jordan: comparison between Bedouins and urban schoolchildren using the International Study of Asthma and Allergies in Childhood phase III protocol. Allergy Asthma Proc. 2009 Mar-Apr;30(2):181-5. doi: 10.2500/aap.2009.30.3208.
PubMed 19463207Khassawneh BY, Samrah SM, Jarrah MI, Ibdah RK, Ibnian AM, Al-Mistarehi AW, Zghayer AA, Abuqudairi SI, Khader YS. Prevalence of undiagnosed COPD in male patients with coronary artery disease: a cross-sectional study in Jordan. Int J Chron Obstruct Pulmon Dis. 2018 Sep 5;13:2759-2766. doi: 10.2147/COPD.S172679. eCollection 2018.
PubMed 30233166Lavorini F, Fontana GA, Usmani OS. New inhaler devices - the good, the bad and the ugly. Respiration. 2014;88(1):3-15. doi: 10.1159/000363390. Epub 2014 May 27.
PubMed 24902629Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.
PubMed 21367593Basheti IA, Obeidat NM, Ammari WG, Reddel HK. Associations between inhaler technique and asthma control among asthma patients using pressurised MDIs and DPIs. Int J Tuberc Lung Dis. 2016 May;20(5):689-95. doi: 10.5588/ijtld.15.0557.
PubMed 27084826Duarte-de-Araujo A, Teixeira P, Hespanhol V, Correia-de-Sousa J. COPD: misuse of inhaler devices in clinical practice. Int J Chron Obstruct Pulmon Dis. 2019 May 30;14:1209-1217. doi: 10.2147/COPD.S178040. eCollection 2019.
PubMed 31213798Basheti IA, Obeidat NM, Reddel HK. Inhaler technique education and asthma control among patients hospitalized for asthma in Jordan. Saudi Pharm J. 2018 Dec;26(8):1127-1136. doi: 10.1016/j.jsps.2018.06.002. Epub 2018 Jul 7.
PubMed 30532633
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based Teach-to-goal Intervention on Inhaler Technique on Adults With Asthma and COPD: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05664347
- Acronym / sponsor ID
- 124454
- Conditions
- COPD, Asthma, Inhaled Steroid Dependent Asthma
- Keywords
- Video-Based, Teach To Goal Education, Chronic Obstructive Pulmonary Disease, Asthma, Randomized Controlled Trial, Patient Education, Quality of Life, Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 23 Dec 2022 (actual)
- 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.
This study was an interventional educational study that was intended to find out the effect of a video based inhaler technique education on improving inhaler technique mastery, disease control, medication adherence and patient quality of life in comparison to verbal education among adults with asthma or COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients diagnosed with asthma or COPD, who were started on any inhaler for a minimum of one month and will continue using them chronically were met in the JUH respiratory clinic and invited to participate. Patients at high risk for infection, or those presenting with a very severe clinical presentation were excluded. Taking into account the non-invasive nature of the educational intervention, and the need to reduce the risk of spread of COVID19 virus (sharing pens or papers), a verbal consent was obtained. Enrolled participants were randomized using simple randomization into two groups; odd numbers for the control group (received a verbal TTG education on their inhaler technique) and even numbers for the intervention group ( received a video based TTG education). The primary and secondary outcomes of the study were inhaler technique mastery, amelioration of disease control, disease related quality of life and medication adherence at follow-up (after 3 months).
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Verbal teach to goal educationStandard verbal teach to goal inhaler technique education |
| Intervention | Active comparator | Behavioral: Video based teach to goal educationVideo based teach to goal inhaler technique education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of Asthma or COPD.
- Started on one or more inhaler devices for a minimum of one month.
- Expected to continue using their inhaler devices chronically.
Key exclusion criteria (2 listed)
- Patients at high risk of infection (immunocompromised).
- Patients presenting with a very severe clinical presentation (severe dyspnoea, confusion due to hypoxemia, the need for continuous oxygen therapy).
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 |
|---|---|---|
| Verbal teach to goal educationAlso: verbal TTGParticipants were showed how to use correctly their inhalers and then asked again to show the technique. For each incorrect step, the patients were corrected and asked to repeat the steps until they mastered the technique. This process was repeated a maximum of three times. | Behavioural | Control |
| Video based teach to goal educationAlso: video-based TTGParticipants were educated by the a video-based teach to goal method. using a smartphone, an educational video illustrating the correct technique for each of the inhalers used by the patient was displayed. After watching the video, the patients were asked to show again how to use their inhaler and for each wrong step the video was displayed again until mastering the correct technique a maximum of three times. At the end of the interview participants in the intervention group received a copy of the video via WhatsApp and were all invited to watch the video whenever needed. | Behavioural | Intervention |
Primary outcome
Number of participants with correct Inhaler technique
Time frame: At base line "first interview"
The ability of the participants to use their inhaler devices correctly: using standardized checklists
Number of participants with correct Inhaler technique
Time frame: After three months of intervention "second interview"
The ability of the participants to use their inhaler devices correctly: using standardized checklists
10 secondary outcomes
Number of participants with moderate-high medication adherence
Time frame: At base line "first interview"
Number of participants with moderate-high medication adherence
Time frame: After Three months of intervention "second interview"
Number of asthmatic patients with well-controlled Disease
Time frame: At base line "first interview"
Number of asthmatic patients with well-controlled Disease
Time frame: After Three months of intervention "second interview"
Number of COPD patients with well-controlled Disease
Time frame: At base line "first interview"
Number of COPD patients with well-controlled Disease
Time frame: After Three months of intervention "second interview"
Asthma related quality of life
Time frame: At base line "first interview"
Asthma related quality of life
Time frame: After Three months of intervention "second interview"
COPD related quality of life
Time frame: At base line "first interview"
COPD related quality of life
Time frame: After Three months of intervention "second interview"
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 23 Dec 2022.
- BackgroundG.I.f.C.O.L.D. (GOLD), Global Strategy for the Diagnosis, Managment, and Prevention of Chronic Obstructive Pulmonary Disease, 2020. https://goldcopd.org/gold-reports/. (Accessed November 11, 2019.
- BackgroundG.I.f.A. (GINA), Global Strategy for Ashtma Managment and Prevention, 2021. https://ginasthma.org/gina-reports/. (Accessed June 15, 2021.
- BackgroundW.H.O. WHO, Chronic Obstructive Pulmonary Disease (COPD) 2017. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd). (Accessed January, 22 2020.
- BackgroundW.H.O. WHO, Asthma, 2020. https://www.who.int/news-room/q-a-detail/asthma. (Accessed May, 24 2020.
- BackgroundEuropean Respiratory Society, The Global Impact of Respiratory Disease, Sheffield, 2017.
- BackgroundThe global asthma report (GAR), The Burden of Asthma, 2018. http://www.globalasthmareport.org/burden/mortality.php. (Accessed February, 18 2020.
- Background: PubMed 33731990Lokke A, Lange P, Lykkegaard J, Ibsen R, Andersson M, de Fine Licht S, Hilberg O. Economic Burden of COPD by Disease Severity - A Nationwide Cohort Study in Denmark. Int J Chron Obstruct Pulmon Dis. 2021 Mar 10;16:603-613. doi: 10.2147/COPD.S295388. eCollection 2021.
- BackgroundC.f.D.C.a.P. CDC, Chronic obstructive pulmonary disease (COPD), 2021. https://www.cdc.gov/copd/infographics/copd-costs.html. (Accessed Jan, 11 2021 2021).
- Background: PubMed 19463207Abu-Ekteish F, Otoom S, Shehabi I. Prevalence of asthma in Jordan: comparison between Bedouins and urban schoolchildren using the International Study of Asthma and Allergies in Childhood phase III protocol. Allergy Asthma Proc. 2009 Mar-Apr;30(2):181-5. doi: 10.2500/aap.2009.30.3208.
- Background: PubMed 30233166Khassawneh BY, Samrah SM, Jarrah MI, Ibdah RK, Ibnian AM, Al-Mistarehi AW, Zghayer AA, Abuqudairi SI, Khader YS. Prevalence of undiagnosed COPD in male patients with coronary artery disease: a cross-sectional study in Jordan. Int J Chron Obstruct Pulmon Dis. 2018 Sep 5;13:2759-2766. doi: 10.2147/COPD.S172679. eCollection 2018.
- Background: PubMed 24902629Lavorini F, Fontana GA, Usmani OS. New inhaler devices - the good, the bad and the ugly. Respiration. 2014;88(1):3-15. doi: 10.1159/000363390. Epub 2014 May 27.
- Background: PubMed 21367593Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.
- Individual participant dataSharing planned: No
Related trials for COPD
Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal teach to goal education and Video based teach to goal education in people with COPD and Asthma, run by University of Jordan at 1 site in Jordan.
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 2 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 23 Dec 2022. 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 Jordan. 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?
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?
Number of participants with correct Inhaler technique (time frame: At base line "first interview"). The study lists 2 primary outcomes in all. 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 NCT05664347, which also lists 69 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 23 Dec 2022.