Prospective Study of the Feedback From an Adherence Monitor on Asthma Control (INCA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital
ClinicalTrials.gov Identifier:
NCT01529697
First received: February 7, 2012
Last updated: January 11, 2016
Last verified: January 2016
  Purpose

Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration

The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.

In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.


Condition Intervention
Asthma
Behavioral: Active Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

Further study details as provided by Beaumont Hospital:

Primary Outcome Measures:
  • Adherence rate [ Time Frame: at three months ] [ Designated as safety issue: No ]
    The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.) and incorporating, by audio analysis, if the inhaler was used correctly.


Secondary Outcome Measures:
  • Asthma quality of life score [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    The asthma quality of life score will be related to adherence, The baseline asthma quality of life score and the quality of life score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.

  • Peak Expiratory Flow Rate [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    The peak expiratory flow rate will be related to adherence, The baseline peak expiratory flow rate and the peak expiratory flow rate at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.

  • Asthma Control Test [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    The asthma control test score will be related to adherence, The baseline asthma control test score and the score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.

  • Asthma Exacerbations [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
    The frequency in exacerbations over the three months will be compared between the active and control arms.

  • Asthma Reliever Medication Use [ Time Frame: over 3 months ] [ Designated as safety issue: No ]
    The change in frequency of reliever use per month from baseline to the end of the study will be compared between active and control patients.


Enrollment: 220
Study Start Date: February 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Feedback
In this arm patients will receive monthly review and education on inhaler technique and use based on a computer download of their last month of inhaler use
Behavioral: Active Feedback
The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.
Other Name: Feedback from a computer log of inhaler use
Placebo Comparator: Control
In this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education.
Behavioral: Active Feedback
The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.
Other Name: Feedback from a computer log of inhaler use

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
  • At least one exacerbation in the previous year with systemic glucocorticoids
  • Uncontrolled/Partially Controlled Asthma by GINA guidelines

Exclusion Criteria:

  • Allergy to salmeterol/fluticasone
  • Patients Controlled by GINA guidelines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529697

Locations
Ireland
Beaumont Hospital
Dublin, Ireland, Dublin 9
Sponsors and Collaborators
Beaumont Hospital
Investigators
Principal Investigator: Richard Costello, MD Beaumont Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Richard Costello, Professor of Medicine, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT01529697     History of Changes
Other Study ID Numbers: BeaumontH 
Study First Received: February 7, 2012
Last Updated: January 11, 2016
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Beaumont Hospital:
Asthma
Inhaler use

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2016