- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170883
EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
December 8, 2020 updated by: Mary De Vera, University of British Columbia
Between 8% and 12% of Canadians suffer from asthma.
Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
271
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- UBC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- individuals who fill a (incident or prevalent) prescription for inhaled corticosteroids (either monotherapy or in combination inhaler with long-acting beta-agonists) who have been diagnosed by a doctor as having asthma
- possessing a cell-phone with ability to send/receive text messages
- residing in British Columbia (BC), Canada and planning to reside in BC for the next 12 months
- registered with the medical services plan (MSP, the provincial insure of medically-required services) in the past 12 months, and planning to remain registered for the next 12 months
- designated pharmacy being the main drugstore for patient
- not participating in another interventional study
- consent to participate in the study.
Exclusion Criteria:
- Unable to communicate in English
- Under 14 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interactive SMS
Intervention with interactive SMS (text messaging) by which patients are asked to disclose their level of agreement with the following statement "I follow my asthma medication plan" and pharmacist follow-up
|
|
Active Comparator: Usual care
Pharmacist conducted patient education, counseling and action-plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to inhaled corticosteroid medication
Time Frame: 12 months
|
Adherence assessed by medication possession ratio
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma control
Time Frame: Baseline
|
Asthma control assessed by the Asthma Control Test
|
Baseline
|
Asthma control
Time Frame: 6 months
|
Asthma control assessed by the Asthma Control Test
|
6 months
|
Asthma control
Time Frame: 12 months
|
Asthma control assessed by the Asthma Control Test
|
12 months
|
Quality of life measured by the Asthma Quality of Life Questionnaire
Time Frame: Baseline
|
Quality of life measured by the Asthma Quality of Life Questionnaire
|
Baseline
|
Quality of life measured by the Asthma Quality of Life Questionnaire
Time Frame: 3 months
|
Quality of life measured by the Asthma Quality of Life Questionnaire
|
3 months
|
Quality of life measured by the Asthma Quality of Life Questionnaire
Time Frame: 12 months
|
Quality of life measured by the Asthma Quality of Life Questionnaire
|
12 months
|
Health care resource utilization
Time Frame: 12 months
|
Asthma-related hospital admissions and emergency department visits
|
12 months
|
Use of reliever medication for acute asthma attacks
Time Frame: 12 months
|
Use of reliever medication for acute asthma attacks
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary De Vera, PhD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
June 19, 2014
First Submitted That Met QC Criteria
June 19, 2014
First Posted (Estimate)
June 23, 2014
Study Record Updates
Last Update Posted (Actual)
December 10, 2020
Last Update Submitted That Met QC Criteria
December 8, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H14-01451
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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