Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive; Asthma
• Interventions: Device: Feedback; Behavioral: Education

• Registration Number: NCT02203266
• Lead Sponsor: Beaumont Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-07-27
• Study First Submitted QC: 2014-07-27
• Study First Posted: 2014-07-29
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feedback	Feedback	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.
Demonstration	Education	Current best practice - inhaler technique education

Primary Outcome Measures

Name	Time	Method
Rate of adherence	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.

Secondary Outcome Measures

Name	Time	Method
Rescue antibiotic and/or steroid medication use	6 months
Adherence in the time domain	Two months and six months
Rescue inhaled medication use	Six months
Quality of life	2 months and 6 months
Technique adherence	Two months and six months

Trial Locations

Locations (1)

Boots Retail (Ireland) Limited; 🇮🇪 Dublin, Ireland