NCT02170883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

3.8 years

First QC Date

June 19, 2014

Last Update Submit

December 8, 2020

Conditions

Asthma

Keywords

asthmamHealthcluster randomized controlled trialpharmacy practicepharmacist

Outcome Measures

Primary Outcomes (1)

  • Adherence to inhaled corticosteroid medication

    Adherence assessed by medication possession ratio

    12 months

Secondary Outcomes (8)

  • Asthma control

    Baseline

  • Asthma control

    6 months

  • Asthma control

    12 months

  • Quality of life measured by the Asthma Quality of Life Questionnaire

    Baseline

  • Quality of life measured by the Asthma Quality of Life Questionnaire

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Interactive SMS

EXPERIMENTAL

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

Other: Interactive SMS

Usual care

ACTIVE COMPARATOR

Pharmacist conducted patient education, counseling and action-plan

Other: Usual care

Interventions

Interactive SMSOTHER
Interactive SMS
Usual careOTHER
Usual care

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to communicate in English
  • Under 14 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25494702DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mary De Vera, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 23, 2014

Study Start

May 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations

CA(1)