Clinical trial NCT01529697: Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
Official title: Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Inhaler use
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility 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

Primary outcomes:
measure: Adherence rate
timeFrame: at three months
Secondary outcomes:
measure: Asthma quality of life score
timeFrame: at 3 months
measure: Peak Expiratory Flow Rate
timeFrame: at 3 months
measure: Asthma Control Test
timeFrame: at 3 months
measure: Asthma Exacerbations
timeFrame: over 3 months
measure: Asthma Reliever Medication Use
timeFrame: over 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital
name: Richard Costello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.