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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203266
• Other study ID #: RC004
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2019
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 by poor inhaler compliance and usage.

• An improvement in patient quality of life scores

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Behavioral:
• Education
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.

Locations

Country	Name	City	State
Ireland	Boots Retail (Ireland) Limited	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Beaumont Hospital	Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rescue inhaled medication use		Six months
Secondary	Rescue antibiotic and/or steroid medication use		6 months
Secondary	Quality of life		2 months and 6 months
Secondary	Adherence in the time domain		Two months and six months
Secondary	Technique adherence		Two months and six months