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EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interactive SMS
Usual care
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring asthma, mHealth, cluster randomized controlled trial, pharmacy practice, pharmacist

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UBC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive SMS

Usual care

Arm Description

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

Pharmacist conducted patient education, counseling and action-plan

Outcomes

Primary Outcome Measures

Adherence to inhaled corticosteroid medication
Adherence assessed by medication possession ratio

Secondary Outcome Measures

Asthma control
Asthma control assessed by the Asthma Control Test
Asthma control
Asthma control assessed by the Asthma Control Test
Asthma control
Asthma control assessed by the Asthma Control Test
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Health care resource utilization
Asthma-related hospital admissions and emergency department visits
Use of reliever medication for acute asthma attacks
Use of reliever medication for acute asthma attacks

Full Information

First Posted
June 19, 2014
Last Updated
December 8, 2020
Sponsor
University of British Columbia
Collaborators
WelTel, College of Pharmacists of British Columbia, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02170883
Brief Title
EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Official Title
EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
WelTel, College of Pharmacists of British Columbia, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, mHealth, cluster randomized controlled trial, pharmacy practice, pharmacist

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive SMS
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Pharmacist conducted patient education, counseling and action-plan
Intervention Type
Other
Intervention Name(s)
Interactive SMS
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Adherence to inhaled corticosteroid medication
Description
Adherence assessed by medication possession ratio
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Asthma control
Description
Asthma control assessed by the Asthma Control Test
Time Frame
Baseline
Title
Asthma control
Description
Asthma control assessed by the Asthma Control Test
Time Frame
6 months
Title
Asthma control
Description
Asthma control assessed by the Asthma Control Test
Time Frame
12 months
Title
Quality of life measured by the Asthma Quality of Life Questionnaire
Description
Quality of life measured by the Asthma Quality of Life Questionnaire
Time Frame
Baseline
Title
Quality of life measured by the Asthma Quality of Life Questionnaire
Description
Quality of life measured by the Asthma Quality of Life Questionnaire
Time Frame
3 months
Title
Quality of life measured by the Asthma Quality of Life Questionnaire
Description
Quality of life measured by the Asthma Quality of Life Questionnaire
Time Frame
12 months
Title
Health care resource utilization
Description
Asthma-related hospital admissions and emergency department visits
Time Frame
12 months
Title
Use of reliever medication for acute asthma attacks
Description
Use of reliever medication for acute asthma attacks
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary De Vera, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25494702
Citation
De Vera MA, Sadatsafavi M, Tsao NW, Lynd LD, Lester R, Gastonguay L, Galo J, FitzGerald JM, Brasher P, Marra CA. Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial. Trials. 2014 Dec 13;15:488. doi: 10.1186/1745-6215-15-488.
Results Reference
derived

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