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

Beaumont Hospital

Status: Completed

Conditions: Asthma

Treatments: Behavioral: Active Feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT01529697

BeaumontH

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups, including a placebo group

Active Feedback

Active Comparator group

Description:

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

Treatment:

Behavioral: Active Feedback

Control

Placebo Comparator group

Description:

In this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education.

Treatment:

Behavioral: Active Feedback