Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
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
1 other identifier
interventional
152
1 country
1
Brief 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 by poor inhaler compliance and usage.
- An improvement in patient quality of life scores
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Feb 2014
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJuly 18, 2019
July 1, 2019
2.8 years
July 27, 2014
July 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of adherence
The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
2 months and 6 months
Secondary Outcomes (5)
Rescue inhaled medication use
Six months
Rescue antibiotic and/or steroid medication use
6 months
Quality of life
2 months and 6 months
Adherence in the time domain
Two months and six months
Technique adherence
Two months and six months
Study Arms (3)
Feedback
EXPERIMENTALFeedback 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 COMPARATORCurrent best practice - inhaler technique education
Control
NO INTERVENTIONUsual care in the community pharmacy setting
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beaumont Hospitallead
- Royal College of Surgeons, Irelandcollaborator
Study Sites (1)
Boots Retail (Ireland) Limited
Dublin, Ireland
Related Publications (1)
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.
PMID: 27142873DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Costello, Professor
Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Richard Costello
Study Record Dates
First Submitted
July 27, 2014
First Posted
July 29, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
July 18, 2019
Record last verified: 2019-07