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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Active Feedback

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, Dublin 9
    • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Feedback from a computer log of inhaler use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Asthma Exacerbations	The frequency in exacerbations over the three months will be compared between the active and control arms.	over 3 months
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

Collaborators and Investigators

• Sponsor: Beaumont Hospital
• Investigators: Principal Investigator: Richard Costello, MD, Beaumont Hospital

Publications and helpful links

General Publications

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
• Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018 Jan 4;51(1):1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.
• Sulaiman I, Seheult J, MacHale E, Boland F, O'Dwyer SM, Rapcan V, D'Arcy S, Cushen B, Mokoka M, Killane I, Ryder SA, Reilly RB, Costello RW. A Method to Calculate Adherence to Inhaled Therapy that Reflects the Changes in Clinical Features of Asthma. Ann Am Thorac Soc. 2016 Nov;13(11):1894-1903. doi: 10.1513/AnnalsATS.201603-222OC.
• Sulaiman I, Mac Hale E, Holmes M, Hughes C, D'Arcy S, Taylor T, Rapcan V, Doyle F, Breathnach A, Seheult J, Murphy D, Hunt E, Lane SJ, Sahadevan A, Crispino G, Diette G, Killane I, Reilly RB, Costello RW. A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma. BMJ Open. 2016 Jan 4;6(1):e009350. doi: 10.1136/bmjopen-2015-009350.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimate): February 9, 2012

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Inhaler use
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: BeaumontH