Clinical trial NCT02203266: Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Pulmonary Disease, Chronic Obstructive
Keywords: Medication Adherence
Patient Compliance
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons, Ireland
First posted: 2014-07-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months

Primary outcomes:
measure: Rate of adherence
timeFrame: 2 months and 6 months
Secondary outcomes:
measure: Rescue inhaled medication use
timeFrame: Six months
measure: Rescue antibiotic and/or steroid medication use
timeFrame: 6 months
measure: Quality of life
timeFrame: 2 months and 6 months
measure: Adherence in the time domain
timeFrame: Two months and six months
measure: Technique adherence
timeFrame: Two months and six months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Boots Retail (Ireland) Limited
Study officials:
affiliation: Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
name: Richard Costello, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.