AsthmaNCT02203266
Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
A study testing Feedback and Education in people with Asthma and Pulmonary Disease, Chronic Obstructive, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to: Improved compliance with prescribed inhaler use Improved technique of inhaler use A reduction in respiratory health related outcomes caused… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Feedback and Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 years old or above
- Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
- Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
- Able and willing to take inhaled medication.
- Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
- Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.
Who cannot join
- Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting
The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:
- Improved compliance with prescribed inhaler use
- Improved technique of inhaler use
- A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
- An improvement in patient quality of life scores
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Being tested
- Feedback, Education
- Keywords
- Medication Adherence, Patient Compliance
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackDevice
Also called INCA Device
Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.
EducationBehavioural
Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Experimental | Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months. Receives: Device: Feedback |
| Demonstration | Active comparator | Current best practice - inhaler technique education Receives: Behavioral: Education |
| Control | No intervention | Usual care in the community pharmacy setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence
The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
Measured: 2 months and 6 months
Secondary outcomes (5)
Rescue inhaled medication use
Measured: Six months
Rescue antibiotic and/or steroid medication use
Measured: 6 months
Quality of life
Measured: 2 months and 6 months
Adherence in the time domain
Measured: Two months and six months
Technique adherence
Measured: Two months and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard Costello, Professor, Principal investigator, Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203266
- Sponsor's protocol ID
- RC004
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2014
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Dwyer SM, MacHale E, Sulaiman I, Holmes M, Hughes C, D'Arcy S, Rapcan V, Taylor T, Boland F, Bosnic-Anticevich S, Reilly RB, Ryder SA, Costello RW. The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA(R), in a community pharmacy setting: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):226. doi: 10.1186/s13063-016-1362-9.
PubMed 27142873
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting
- ClinicalTrials.gov ID
- NCT02203266
- Acronym / sponsor ID
- RC004
- Conditions
- Asthma, Pulmonary Disease, Chronic Obstructive
- Keywords
- Medication Adherence, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:
- Improved compliance with prescribed inhaler use
- Improved technique of inhaler use
- A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
- An improvement in patient quality of life scores
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Device: FeedbackFeedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months. |
| Demonstration | Active comparator | Behavioral: EducationCurrent best practice - inhaler technique education |
| Control | No intervention | –Usual care in the community pharmacy setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be 18 years old or above
- Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
- Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
- Able and willing to take inhaled medication.
- Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
Key exclusion criteria (1 listed)
- Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months
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 |
|---|---|---|
| FeedbackAlso: INCA DeviceFeedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months. | Device | Feedback |
| EducationFeedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months. | Behavioural | Demonstration |
Primary outcome
Rate of adherence
Time frame: 2 months and 6 months
The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
5 secondary outcomes
Rescue inhaled medication use
Time frame: Six months
Rescue antibiotic and/or steroid medication use
Time frame: 6 months
Quality of life
Time frame: 2 months and 6 months
Adherence in the time domain
Time frame: Two months and six months
Technique adherence
Time frame: Two months and six months
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 18 Jul 2019.
- Derived from this study: PubMed 27142873O'Dwyer SM, MacHale E, Sulaiman I, Holmes M, Hughes C, D'Arcy S, Rapcan V, Taylor T, Boland F, Bosnic-Anticevich S, Reilly RB, Ryder SA, Costello RW. The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA(R), in a community pharmacy setting: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):226. doi: 10.1186/s13063-016-1362-9.
Related trials for Asthma
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)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
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.
Richard Costello, Professor principal investigator
Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback and Education in people with Asthma and Pulmonary Disease, Chronic Obstructive, run by Beaumont Hospital at 1 site in Ireland.
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 6 inclusion and 1 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 18 Jul 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 Ireland. 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?
Rate of adherence (time frame: 2 months and 6 months). 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 NCT02203266, 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 18 Jul 2019.