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

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 Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Asthma
• Intervention / Treatment: Device: Feedback; Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Boots Retail (Ireland) Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: INCA Device
Active Comparator: Demonstration; Current best practice - inhaler technique education	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.
No Intervention: Control; Usual care in the community pharmacy setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Beaumont Hospital
• Collaborators: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Richard Costello, Professor, Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 27, 2014
• First Submitted That Met QC Criteria: July 27, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Medication Adherence; Patient Compliance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RC004