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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
|Official Title:||Prospective Study of the Feedback From an Adherence Monitor on Asthma Control|
- Adherence rate [ Time Frame: at three months ] [ Designated as safety issue: No ]The rate of adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The adherence will be the number of doses taken at the correct time. The 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.
- 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.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529697
|Contact: Richard W Costello, MDfirstname.lastname@example.org|
|Contact: Elaine MacHale, RN MScemail@example.com|
|Dublin, Ireland, Dublin 9|
|Contact: Elaine MacHale, Rn MSc firstname.lastname@example.org|
|Contact: Imran Sulaiman, MD email@example.com|
|Principal Investigator:||Richard Costello, MD||Beaumont Hospital|