Asthma in ChildrenNCT06531096
Optimising Inhaler Technique and Asthma Self-management in Children and Young People
A study testing v-DOT in people with Asthma in Children, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The aim of this randomised pilot study is to explore ways to optimise a care pathway that results in children and young people with asthma being better trained in the basics of asthma care and better able to apply self-management at the earliest possible stage. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- v-DOT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2022to 1 Sep 2024
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-15 years of age (up to 16th birthday)
- Established asthmatic children (prescribed an inhaled corticosteroid preventer), who have been admitted or referred for paediatric ward review or attended A\&E with their 2nd acute wheeze episode within a 6-month period.
- Established asthmatic children (prescribed an inhaled corticosteroid preventer), with inadequate control whom medical staff feel would benefit from further education.
- 3rd viral induced wheezing episode within 6 months, in those already prescribed an inhaled corticosteroid preventer (but not formally 'asthma').
- English and non-English speaking children and young people will be eligible as we have access to translation services that are already utilised at our asthma clinics.
Who cannot join
- Children who have previously received intervention through the safe asthma discharge care pathway service.
- < 1 year of age.
- Children and young people with cough but no wheeze.
- Those children who are referred to paediatric asthma clinic or nurse led asthma clinic, where they have received teach back training on inhaler technique/nasal spray technique and PAAP training.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Belfast Health and Social care trust
Belfast, BT12 6BA
About this study
The aim of this randomised pilot study is to explore ways to optimise a care pathway that results in children and young people with asthma being better trained in the basics of asthma care and better able to apply self-management at the earliest possible stage.
This will involve comparing a novel augmented teaching method (Video directly observed therapy (v-DOT)) with standard training in achieving and sustaining mastery of inhaler and nasal spray technique and the understanding of a personalised asthma action plan (PAAP).
Read the detailed description
The aim of this randomised pilot study is to explore ways to optimise a care pathway that results in children and young people with asthma being better trained in the basics of asthma care and better able to apply self-management at the earliest possible stage.
This will involve comparing a novel augmented teaching method (Video directly observed therapy (v-DOT)) with standard training in achieving and sustaining mastery of inhaler and nasal spray technique and the understanding of a personalised asthma action plan (PAAP).
Children with acute wheezing referred to the Safe Asthma Discharge Care Pathway (SADCP) service will be approached for participation. Participants will then be randomised 1:1 to either remain in the SADCP (control) or to receive the v-DOT enhancement (intervention).
All enrolled patients will have an educational session with an asthma nurse using teach back methodology to teach inhaler and/or nasal spray technique and personalised asthma action plan (PAAP). During this session education is given on what asthma is, identifying and avoiding triggers, asthma treatments, and side effects of treatment.
The control participants will have a further assessment and educational sessions using teach back methodology to ensure correct inhaler technique is mastered and understanding of how to action the three zones of the PAAP until they have achieved 'mastery' of the technique and understanding of PAAP.
The intervention group will immediately have the v-DOT App downloaded to their phone or tablet and will be instructed on how to take and upload audio-videos of themselves or their child taking their inhaler and/or nasal spray. The use of v-DOT to upload audio videos with feedback will continue until the patient has uploaded 3 consecutive days of correct technique (up to a maximum of 21 days). Reminders will be sent via email if the patient fails to upload any videos for 24 hours to serve as a prompt for uploading the daily videos.
It is not possible to blind either the participants or the assessors due to the nature of the intervention itself. As this is a pilot study, no sample size has been calculated. A convenience sample will be enrolled over the course of 6-9 months.
Mastery of inhaler technique will be defined as absence of healthcare professional detected errors. Inhaler technique and nasal spray technique will be scored on locally agreed checklists, informed by a scoping review on how inhaler technique is assessed in children and young people and reviewed by the local Asthma multidisciplinary team to agree critical steps. These checklists have been adapted to include "critical errors" in the steps. In addition, a global assessment will be made: correct, partially correct and poor technique. Scoring of inhaler technique will be performed independently by two members of the research team to account for inter-observer variability.
All participants (control and intervention) will be followed up at 1 month, 3 months and 6 months after achieving mastery of technique.
Teaching of the unique personalised asthma action plan (PAAP) is an integral part of the teach back process at the safe asthma discharge care pathway service. The investigators will assess new patient's understanding of their PAAP as they enter the SADCP (prior to education) and compare this to their understanding at follow up. The investigators will compare long term PAAP understanding of the control group (who will have received additional teach back sessions) to the intervention group (who will have received only 1 teach back session). The investigators will also compare patient's understanding of their PAAP with clinical outcomes.
In order to determine if v-DOT has promise of being cost effective in comparison to standard care, a within-study cost-effectiveness analysis will be conducted from the provider perspective (health services).
To explore potential reasons for poor inhaler technique, incorrect implementation of personalised asthma action plans and potential barriers encountered and to evaluate the experiences of the participants to determine if they feel that this method of teaching and monitoring technique is acceptable, participants will be invited to participate in semi-structured interviews.
- Conditions
- Asthma in Children
- Being tested
- v-DOT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
v-DOTBehavioural
Video directly observed therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group- v-DOT | Experimental | The intervention group will have the v-DOT (video directly observed therapy) App downloaded to their Phone or Tablet and will be instructed on how to take and upload audio-videos of themselves or their child taking their inhaler and/or nasal spray.
The audio videos will be time/date stamped and forwarded to the secure repository. Depending on the prescribed frequency of the preventer asthma and allergic rhinitis inhalers or sprays these audio videos will be uploaded once or twice-daily. These videos will be reviewed every morning by the lead researcher (trained in inhaler and nasal spray technique assessment and training) who will provide feedback via email or an instant messenger service. Videos will be evaluated using an inhaler/ nasal spray checklist.
The use of v-DOT to upload audio videos with feedback will continue until the patient has uploaded 3 consecutive days of correct technique (up to a maximum of 21 days). Receives: Behavioral: v-DOT |
| Control group- standard care | No intervention | All enrolled patients will have an educational session with an asthma nurse using teach back methodology to teach inhaler and/or nasal spray technique and personalised asthma action plan (PAAP). During this session education is given on what asthma is, identifying and avoiding triggers, asthma treatments, and side effects of treatment. The control participants will have further assessment and educational sessions using teach back methodology to ensure correct inhaler technique is mastered and understanding of how to action the three zones of the PAAP until they have achieved 'mastery' of the technique and understanding of their PAAP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mastery of technique
Number of days of video directly observed therapy (v-DOT) required to achieve 'mastery' following one initial educational session using teach back methodology for asthma inhaler +/- nasal spray (for those with concomitant allergic rhinitis).
Measured: Once mastery of technique established which is defined as 3 consecutive days of correct technique.
Technique score
Inhaler with or without nasal spray technique at baseline and 1,3 and 6 months after achieving technique mastery. Technique will be scored as a proportion of the correct steps taken (using locally agreed inhaler and nasal spray checklists). Scores range from 0 to 5, with 5 being the maximum and a higher score having a better outcome. This will then be converted to a percentage. Mastery of inhaler technique will be defined as absence of healthcare professional detected errors. The proportion of correct steps taken will be described for each group using descriptive statistical measures. In addition, a global assessment will be made: correct, partially correct and poor technique.
Measured: Baseline and 1, 3 and 6 months after achieving technique mastery
Personalised asthma action plan (PAAP) understanding.
Understanding of their personalised asthma action plan will be measured at baseline and 1,3 and 6 months after achieving technique mastery. This will be assessed by asking questions using a pre-defined checklist to clarify if they know which medications they should take every day and what they should do if they become unwell with regards to their treatment regime.
Maximum value = 5. Minimum value = 0. A score of 5 means complete understanding of the personalised asthma action plan. A higher score means a better outcome.
Measured: Baseline and 1, 3 and 6 months after achieving technique mastery
Recruitment rates
Recruitment rates and a description of barriers to and how to facilitate.
Measured: Through study recruitment, an average of 1 year.
Retention rates
Patients who complete full follow up and those who withdraw or fail to complete the full study.
Measured: At study completion for all participants, up to 2 years.
Qualitative interviews to identify barriers to using video directly observed therapy (v-DOT)
Barriers to using video directly observed therapy (v-DOT) for example participation rates, technical considerations, ability to correct inhaler error using v-DOT and use of resources.
Measured: 3-6 months after achieving mastery of technique.
Secondary outcomes (9)
Health service resource use and incremental cost-effectiveness.
In order to determine if v-DOT has promise of being cost effective in comparison to standard care, a within-study cost-effectiveness analysis will be conducted from the provider perspective (health services).
Measured: Through study completion, up to 1 year.
Spirometry
Each child who is old enough to perform spirometry in clinic will have their FEV1 and FVC measured using standardised spirometry equipment. The forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximal inspiration. Forced vital capacity (FVC), the maximum amount of air that can be exhaled when blowing out as fast as possible. Expressed in litres. This will then be converted to a percentage predicted when compared to others of the same sex, height and weight and expressed as a percentage. A higher percentage meaning better outcomes.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Fractional exhaled nitric oxide (FeNO)
Each child who is old enough to perform spirometry in clinic will have their Fractional exhaled nitric oxide (FeNO) measured using standardised equipment. Result expressed as parts per billion. Minimum value of 0. No maximum value cut off defined. A higher value means worse outcomes.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Number of prescribed oral corticosteroids
Number of prescribed oral corticosteroids in previous 12 months prior to recruitment and since achieving mastery of technique.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Number of emergency department and out of hours attendances
Number of emergency department and out of hours attendances with acute wheeze in previous 12 months prior to recruitment and since achieving mastery of technique.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Number of admissions with acute wheeze
Number of admissions with acute wheeze in previous 12 months prior to recruitment and the 6 months since achieving mastery of technique. Including length of stay in hospital.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Adherence to inhaled corticosteroid medication.
Adherence to inhaled corticosteroid medication (as determined by General Practitioner prescription pick-ups) and analysed using the medication refill adherence approach. Medication refill adherence is the total days supply divided by the total number of days of study participation and multiplied by 100 to provide a percentage adherence value. Minimum value is 0% and maximum is 100%. A value of 100% having the best outcome.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Children's asthma control test (c-ACT) score.
A validated questionnaire which is scored from 0 to 27. A higher score has a better outcome. A score of 19 or lower means the child's asthma has not been well controlled.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Mini- paediatric quality of life questionnaire score.
A validated quality of life questionnaire. Scored from 13 (minimum score) to 91 (maximum score). A higher scores means a better outcome/ less impact on their quality of life.
Measured: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start17 Nov 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dara O'Donoghue, Queen's University, Belfast
- Investigators
- Dara O'Donoghue, MD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531096
- Sponsor's protocol ID
- 293828
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Inhaler Technique and Asthma Self-management in Children and Young People
- ClinicalTrials.gov ID
- NCT06531096
- Acronym / sponsor ID
- 293828
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 31 Jul 2024 (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.
The aim of this randomised pilot study is to explore ways to optimise a care pathway that results in children and young people with asthma being better trained in the basics of asthma care and better able to apply self-management at the earliest possible stage.
This will involve comparing a novel augmented teaching method (Video directly observed therapy (v-DOT)) with standard training in achieving and sustaining mastery of inhaler and nasal spray technique and the understanding of a personalised asthma action plan (PAAP).
Detailed description
The aim of this randomised pilot study is to explore ways to optimise a care pathway that results in children and young people with asthma being better trained in the basics of asthma care and better able to apply self-management at the earliest possible stage.
This will involve comparing a novel augmented teaching method (Video directly observed therapy (v-DOT)) with standard training in achieving and sustaining mastery of inhaler and nasal spray technique and the understanding of a personalised asthma action plan (PAAP).
Children with acute wheezing referred to the Safe Asthma Discharge Care Pathway (SADCP) service will be approached for participation. Participants will then be randomised 1:1 to either remain in the SADCP (control) or to receive the v-DOT enhancement (intervention).
All enrolled patients will have an educational session with an asthma nurse using teach back methodology to teach inhaler and/or nasal spray technique and personalised asthma action plan (PAAP). During this session education is given on what asthma is, identifying and avoiding triggers, asthma treatments, and side effects of treatment.
The control participants will have a further assessment and educational sessions using teach back methodology to ensure correct inhaler technique is mastered and understanding of how to action the three zones of the PAAP until they have achieved 'mastery' of the technique and understanding of PAAP.
The intervention group will immediately have the v-DOT App downloaded to their phone or tablet and will be instructed on how to take and upload audio-videos of themselves or their child taking their inhaler and/or nasal spray. The use of v-DOT to upload audio videos with feedback will continue until the patient has uploaded 3 consecutive days of correct technique (up to a maximum of 21 days). Reminders will be sent via email if the patient fails to upload any videos for 24 hours to serve as a prompt for uploading the daily videos.
It is not possible to blind either the participants or the assessors due to the nature of the intervention itself. As this is a pilot study, no sample size has been calculated. A convenience sample will be enrolled over the course of 6-9 months.
Mastery of inhaler technique will be defined as absence of healthcare professional detected errors. Inhaler technique and nasal spray technique will be scored on locally agreed checklists, informed by a scoping review on how inhaler technique is assessed in children and young people and reviewed by the local Asthma multidisciplinary team to agree critical steps. These checklists have been adapted to include "critical errors" in the steps. In addition, a global assessment will be made: correct, partially correct and poor technique. Scoring of inhaler technique will be performed independently by two members of the research team to account for inter-observer variability.
All participants (control and intervention) will be followed up at 1 month, 3 months and 6 months after achieving mastery of technique.
Teaching of the unique personalised asthma action plan (PAAP) is an integral part of the teach back process at the safe asthma discharge care pathway service. The investigators will assess new patient's understanding of their PAAP as they enter the SADCP (prior to education) and compare this to their understanding at follow up. The investigators will compare long term PAAP understanding of the control group (who will have received additional teach back sessions) to the intervention group (who will have received only 1 teach back session). The investigators will also compare patient's understanding of their PAAP with clinical outcomes.
In order to determine if v-DOT has promise of being cost effective in comparison to standard care, a within-study cost-effectiveness analysis will be conducted from the provider perspective (health services).
To explore potential reasons for poor inhaler technique, incorrect implementation of personalised asthma action plans and potential barriers encountered and to evaluate the experiences of the participants to determine if they feel that this method of teaching and monitoring technique is acceptable, participants will be invited to participate in semi-structured interviews.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group- v-DOT | Experimental | Behavioral: v-DOTThe intervention group will have the v-DOT (video directly observed therapy) App downloaded to their Phone or Tablet and will be instructed on how to take and upload audio-videos of themselves or their child taking their inhaler and/or nasal spray. The audio videos will be time/date stamped and forwarded to the secure repository. Depending on the prescribed frequency of the preventer asthma and allergic rhinitis inhalers or sprays these audio videos will be uploaded once or twice-daily. These videos will be reviewed every morning by the lead researcher (trained in inhaler and nasal spray technique assessment and training) who will provide feedback via email or an instant messenger service. Videos will be evaluated using an inhaler/ nasal spray checklist. The use of v-DOT to upload audio videos with feedback will continue until the patient has uploaded 3 consecutive days of correct technique (up to a maximum of 21 days). |
| Control group- standard care | No intervention | –All enrolled patients will have an educational session with an asthma nurse using teach back methodology to teach inhaler and/or nasal spray technique and personalised asthma action plan (PAAP). During this session education is given on what asthma is, identifying and avoiding triggers, asthma treatments, and side effects of treatment. The control participants will have further assessment and educational sessions using teach back methodology to ensure correct inhaler technique is mastered and understanding of how to action the three zones of the PAAP until they have achieved 'mastery' of the technique and understanding of their PAAP. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1-15 years of age (up to 16th birthday)
- Established asthmatic children (prescribed an inhaled corticosteroid preventer), who have been admitted or referred for paediatric ward review or attended A\&E with their 2nd acute wheeze episode within a 6-month period.
- Established asthmatic children (prescribed an inhaled corticosteroid preventer), with inadequate control whom medical staff feel would benefit from further education.
- 3rd viral induced wheezing episode within 6 months, in those already prescribed an inhaled corticosteroid preventer (but not formally 'asthma').
- English and non-English speaking children and young people will be eligible as we have access to translation services that are already utilised at our asthma clinics.
Key exclusion criteria (4 listed)
- Children who have previously received intervention through the safe asthma discharge care pathway service.
- < 1 year of age.
- Children and young people with cough but no wheeze.
- Those children who are referred to paediatric asthma clinic or nurse led asthma clinic, where they have received teach back training on inhaler technique/nasal spray technique and PAAP training.
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 |
|---|---|---|
| v-DOTVideo directly observed therapy | Behavioural | Intervention group- v-DOT |
Primary outcome
Mastery of technique
Time frame: Once mastery of technique established which is defined as 3 consecutive days of correct technique.
Number of days of video directly observed therapy (v-DOT) required to achieve 'mastery' following one initial educational session using teach back methodology for asthma inhaler +/- nasal spray (for those with concomitant allergic rhinitis).
Technique score
Time frame: Baseline and 1, 3 and 6 months after achieving technique mastery
Inhaler with or without nasal spray technique at baseline and 1,3 and 6 months after achieving technique mastery. Technique will be scored as a proportion of the correct steps taken (using locally agreed inhaler and nasal spray checklists). Scores range from 0 to 5, with 5 being the maximum and a higher score having a better outcome. This will then be converted to a percentage. Mastery of inhaler technique will be defined as absence of healthcare professional detected errors. The proportion of correct steps taken will be described for each group using descriptive statistical measures. In addition, a global assessment will be made: correct, partially correct and poor technique.
Personalised asthma action plan (PAAP) understanding.
Time frame: Baseline and 1, 3 and 6 months after achieving technique mastery
Understanding of their personalised asthma action plan will be measured at baseline and 1,3 and 6 months after achieving technique mastery. This will be assessed by asking questions using a pre-defined checklist to clarify if they know which medications they should take every day and what they should do if they become unwell with regards to their treatment regime. Maximum value = 5. Minimum value = 0. A score of 5 means complete understanding of the personalised asthma action plan. A higher score means a better outcome.
Recruitment rates
Time frame: Through study recruitment, an average of 1 year.
Recruitment rates and a description of barriers to and how to facilitate.
Retention rates
Time frame: At study completion for all participants, up to 2 years.
Patients who complete full follow up and those who withdraw or fail to complete the full study.
Qualitative interviews to identify barriers to using video directly observed therapy (v-DOT)
Time frame: 3-6 months after achieving mastery of technique.
Barriers to using video directly observed therapy (v-DOT) for example participation rates, technical considerations, ability to correct inhaler error using v-DOT and use of resources.
9 secondary outcomes
Health service resource use and incremental cost-effectiveness.
Time frame: Through study completion, up to 1 year.
Spirometry
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Fractional exhaled nitric oxide (FeNO)
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Number of prescribed oral corticosteroids
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Number of emergency department and out of hours attendances
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Number of admissions with acute wheeze
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Adherence to inhaled corticosteroid medication.
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Children's asthma control test (c-ACT) score.
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Mini- paediatric quality of life questionnaire score.
Time frame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Dara O'Donoghue, MD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing v-DOT in people with Asthma in Children, run by Queen's University, Belfast at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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 Kingdom. 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?
Results are not available in the source record.
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?
Mastery of technique (time frame: Once mastery of technique established which is defined as 3 consecutive days of correct technique.). The study lists 6 primary outcomes in all. 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 31 Jul 2024.