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

Asthma Clinical Trial

— INCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529697
• Other study ID #: BeaumontH
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: January 11, 2016
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Beaumont Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate	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.	at three months	No
Secondary	Asthma quality of life score	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.	at 3 months	No
Secondary	Peak Expiratory Flow Rate	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.	at 3 months	No
Secondary	Asthma Control Test	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.	at 3 months	No
Secondary	Asthma Exacerbations	The frequency in exacerbations over the three months will be compared between the active and control arms.	over 3 months	No
Secondary	Asthma Reliever Medication Use	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.	over 3 months	No