A Study of Inhaler Use in the Community

Haphazard and Careless Use of Inhalers, an Observational Study

This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Airways Disease

Detailed Description

Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D9
    • 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

• Sampling Method: Non-Probability Sample

Study Population

The study population will be a random sample of patients with a known history of respiratory illness and already prescribed a salmeterol/fluticosone Diskus inhaler. Patients will be identified in both community pharmacy centres and general practice clinics within Ireland.

Description

Inclusion Criteria:

• Known history of Respiratory Illness
• Prescribed salmeterol/fluticasone Diskus Inhaler

Exclusion Criteria:

• Unable to understand study protocol
• Refusal to sign consent form

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhaler Adherence in Time	This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use.	One month
Inhaler Technique Adherence	This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate.	One Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age Measured in Years at time of recruitment	Relationship of Age to Adherence	one month
Gender Measured as Male or Female	Relationship of Gender to Adherence	One Month
Education Level Measured as either primary, secondary or tertiary school at recruitment.	Relationship of Education Level (Primary/Secondary/Tertiary) to Adherence	One Month
Socio-economic Class Measured as the patient having either Private or Public Health Insurance	Relationship of Socio-economic class (Private or Public Health Insurance) to Adherence	One Month
Health Care Use Measured as the number of visits to a General Practitioner in the previous Year	Relationship of Health Care Use (Frequency of visit to General Practitioner) to Adherence	Previous Year
Hospitalisation Measured as the number of hospital admissions in the previous year	Relationship of Hospitalisation in the prevoius year to Adherence	Previous Year
Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year	Relationship of Exacerbation (Respiratory related in the prevoius year) to Adherence	Previous Year
Background Respiratory Diagnosis, divided into Asthma, COPD and other.	Relationship of Respiratory Diagnosis (Asthma, COPD, other) to Adherence	Previous History
Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker	Relationship of Smoking History (Current, Ex-smoker, never smoker) to Adherence	Previous History

Collaborators and Investigators

• Sponsor: Beaumont Hospital
• Collaborators: GlaxoSmithKline; Health Research Board, Ireland; Asthma Society Ireland; Irish Thoracic Society; Vitalograph Ireland
• Investigators: Principal Investigator: Richard W Costello, MD, RCSI, Beaumont Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

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: Adherence; Asthma; Chronic Obstructive Pulmonary Disease; Inhaler Use
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: INCA-CC