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

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ClinicalTrials.gov Identifier: NCT02203266
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Royal College of Surgeons, Ireland
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Asthma Pulmonary Disease, Chronic Obstructive Device: Feedback Behavioral: Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of adherence [ Time Frame: 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 :
  1. Rescue inhaled medication use [ Time Frame: Six months ]
  2. Rescue antibiotic and/or steroid medication use [ Time Frame: 6 months ]
  3. Quality of life [ Time Frame: 2 months and 6 months ]
  4. Adherence in the time domain [ Time Frame: Two months and six months ]
  5. Technique adherence [ Time Frame: Two months and six months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203266


Locations
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Ireland
Boots Retail (Ireland) Limited
Dublin, Ireland
Sponsors and Collaborators
Beaumont Hospital
Royal College of Surgeons, Ireland
Investigators
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Principal Investigator: Richard Costello, Professor Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Richard Costello, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT02203266    
Other Study ID Numbers: RC004
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Keywords provided by Professor Richard Costello, Beaumont Hospital:
Medication Adherence
Patient Compliance
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive