AsthmaNCT02170883
EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
A study testing Interactive SMS in people with Asthma, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Interactive SMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to communicate in English
- Under 14 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma
- Being tested
- Interactive SMS, Usual care
- Keywords
- asthma, mHealth, cluster randomized controlled trial, pharmacy practice, pharmacist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive SMSOther
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Interactive SMS |
| Usual care | Active comparator | Pharmacist conducted patient education, counseling and action-plan Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to inhaled corticosteroid medication
Adherence assessed by medication possession ratio
Measured: 12 months
Secondary outcomes (8)
Asthma control
Asthma control assessed by the Asthma Control Test
Measured: Baseline
Asthma control
Asthma control assessed by the Asthma Control Test
Measured: 6 months
Asthma control
Asthma control assessed by the Asthma Control Test
Measured: 12 months
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Measured: Baseline
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Measured: 3 months
Quality of life measured by the Asthma Quality of Life Questionnaire
Quality of life measured by the Asthma Quality of Life Questionnaire
Measured: 12 months
Health care resource utilization
Asthma-related hospital admissions and emergency department visits
Measured: 12 months
Use of reliever medication for acute asthma attacks
Use of reliever medication for acute asthma attacks
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMay 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- WelTel, College of Pharmacists of British Columbia, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Mary De Vera, University of British Columbia
- Investigators
- Mary De Vera, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170883
- Sponsor's protocol ID
- H14-01451
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2014
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25494702
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
- ClinicalTrials.gov ID
- NCT02170883
- Acronym / sponsor ID
- H14-01451
- Conditions
- Asthma
- Keywords
- asthma, mHealth, cluster randomized controlled trial, pharmacy practice, pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- WelTel, College of Pharmacists of British Columbia, Canadian Institutes of Health Research (CIHR)
- Study start
- May 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive SMS | Experimental | Other: Interactive SMSIntervention 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 |
| Usual care | Active comparator | Other: Usual carePharmacist conducted patient education, counseling and action-plan |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to communicate in English
- Under 14 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive SMS | Other | Interactive SMS |
| Usual care | Other | Usual care |
Primary outcome
Adherence to inhaled corticosteroid medication
Time frame: 12 months
Adherence assessed by medication possession ratio
8 secondary outcomes
Asthma control
Time frame: Baseline
Asthma control
Time frame: 6 months
Asthma control
Time frame: 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
Time frame: 3 months
Quality of life measured by the Asthma Quality of Life Questionnaire
Time frame: 12 months
Health care resource utilization
Time frame: 12 months
Use of reliever medication for acute asthma attacks
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 25494702De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary De Vera, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive SMS in people with Asthma, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to inhaled corticosteroid medication (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.