Back to resultsTeaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
Primary Purpose
Asthma, Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Feedback
Education
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring Medication Adherence, Patient Compliance
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
Sites / Locations
- Boots Retail (Ireland) Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Feedback
Demonstration
Control
Arm Description
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.
Current best practice - inhaler technique education
Usual care in the community pharmacy setting
Outcomes
Primary Outcome Measures
Rate of adherence
The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
Secondary Outcome Measures
Rescue inhaled medication use
Rescue antibiotic and/or steroid medication use
Quality of life
Adherence in the time domain
Technique adherence
Full Information
NCT ID
NCT02203266
First Posted
July 27, 2014
Last Updated
July 17, 2019
Sponsor
Beaumont Hospital
Collaborators
Royal College of Surgeons, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT02203266
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beaumont Hospital
Collaborators
Royal College of Surgeons, Ireland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Pulmonary Disease, Chronic Obstructive
Keywords
Medication Adherence, Patient Compliance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Demonstration
Arm Type
Active Comparator
Arm Description
Current best practice - inhaler technique education
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care in the community pharmacy setting
Intervention Type
Device
Intervention Name(s)
Feedback
Other Intervention Name(s)
INCA Device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of adherence
Description
The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.
Time Frame
2 months and 6 months
Secondary Outcome Measure Information:
Title
Rescue inhaled medication use
Time Frame
Six months
Title
Rescue antibiotic and/or steroid medication use
Time Frame
6 months
Title
Quality of life
Time Frame
2 months and 6 months
Title
Adherence in the time domain
Time Frame
Two months and six months
Title
Technique adherence
Time Frame
Two months and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Costello, Professor
Organizational Affiliation
Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boots Retail (Ireland) Limited
City
Dublin
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27142873
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.
Results Reference
derived
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Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
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