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Completed

NCT Number: NCT02203266

Teaching Inhaler Use With the INCA Device 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

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Key information

Conditions

Asthma Behavior Bronchial Diseases Chronic Disease Disease Attributes Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boots Retail (Ireland) Limited

Dublin, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FEEDBACK

Device

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

Education

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Collaborators

  • Royal College of Surgeons, Ireland

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 29, 2014
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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