Uncontrolled AsthmaNCT02768623
Evaluation of a Community Pharmacist Managed Asthma Consultation Service
A study testing Pharmacist led Asthma Management and Pharmacist Intervention (when requested by patient) in people with Uncontrolled Asthma, run by Zahava Rosenberg-Yunger.
Trial summary
Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4 million Canadians and over 300 million people worldwide. Unlike most other chronic diseases, asthma affects a significant proportion of children - an estimated 21% in Ontario. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled Asthma
- What is being tested?
- Pharmacist led Asthma Management and Pharmacist Intervention (when requested by patient)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 16 Apr 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provided written consent
- Intending to refill all asthma-related prescriptions at the study pharmacy
- Diagnosed with asthma by a physician or nurse practitioner
- Taking inhaled corticosteroids for which the dose and/or medication has remained unchanged for at least 2 months
- 18 years of age or older
- Uncontrolled asthma (defined as in the past 4 weeks the patient has used their rescue medications 4 or more times in a given week and/or the patient has woken up in the night from their asthma in a given week).
Who cannot join
- Pregnant women
- Unable or unwilling to return to the pharmacy for scheduled visits
- Unable to speak English language well enough to communicate with the pharmacist and complete the questionnaires independently
- Terminal illness or poor prognosis (life expectancy less than 3 years)
- History of alcoholism or drug abuse
- Comorbidities/health issues:
Show all 17Show fewer
- Chronic obstructive pulmonary disorder (emphysema; chronic bronchitis)
- Acute respiratory infection
- Pulmonary fibrosis
- Cancer (in the past 5 years preceding enrolment)
- Organ transplantation
- Dementia, cognitive impairment or other psychiatric disorder (Cognitive Impairments such as those found under the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) common Axis I and Axis II disorders
- Any other health issue that may hinder performance on pulmonary function test
- Enrolled in an Employee Assistance Program for disease management within 6 months preceding the study enrolment date OR planning to enroll in the next 12 months
- Enrolled in another asthma management/clinical study OR planning to enroll in a similar study in the next 12 months
- Had a MedsCheck or MedsCheck Follow-Up done within the 3-month period preceding the anticipated date of the first study appointment
- Patients who do not wish their physician to be notified of their participation
About this study
Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4 million Canadians and over 300 million people worldwide. Unlike most other chronic diseases, asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is also the leading cause of hospitalization for children in Canada and is a significant cause of school and work absenteeism. Though asthma is generally considered a chronic disease, it can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition. Effective management of asthma can prevent exacerbation and more severe negative health consequences. In fact, estimates show that over 80% of the asthma-related deaths could be prevented through proper education. However, evidence also shows that over 55% of patients with moderate to severe asthma do not have their asthma symptoms under control, despite regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma action plan from their physicians, although such plans are associated with fewer ER visits, lower hospitalization rates and improved lung function. Hence, there is a clear opportunity to improve the management of asthma and reduce the incidence of related complications.
Given the scientific evidence of pharmacists effect on asthma management there is a strong rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians suffering from this chronic disease. However, the implementation of such a program should be preceded by a pilot test to ensure that the program parameters are optimized to drive improved patient outcomes and maximum quality of service. The primary goals of this research project are to examine the impact of a pharmacist led asthma management intervention on patient health outcomes and to determine the optimum program structure to ensure quality of service delivery.
This study employs a mixed-methods study design. Investigators will begin with a cluster randomized controlled trial and end with exit interviews.This study will consist of a prospective, randomized controlled trial conducted in the community setting. A total of 12 pharmacies across the Greater Toronto Region will be recruited for this study. Each of these pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. All data will be analyzed using statistical software. Significance level will be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard deviation for the number of patients will be reported. There is a low perceived risk for this study; however, the investigators will take every precaution to ensure this study is conducted in an ethical manner, including protecting patient confidentiality and anonymity.
- Conditions
- Uncontrolled Asthma
- Being tested
- Pharmacist led Asthma Management, Pharmacist Intervention (when requested by patient)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist led Asthma ManagementOther
Also called Pharmacist Asthma Intervention
Pharmacist Intervention (when requested by patient)Other
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in the control group will receive standard, dispensing services they currently receive from pharmacists. Control group pharmacists will continue to provide these services in accordance with the standards of practice adopted by the Ontario College of Pharmacists. They will not provide either of the 3 intervention components outlined above. Should a control group patient request additional information and/or services, the pharmacist will comply and provide these as deemed necessary for the particular patient. This could include the full range of educational and drug therapy optimization services outlined for the intervention group. If this occurs then the pharmacists will document all services provided in order for the research team to account for this in the analysis. Receives: Other: Pharmacist Intervention (when requested by patient) |
| Intervention Group | Experimental | Pharmacists in the intervention group will provide patients with a comprehensive disease management program for asthma. The 3 major components of pharmacists' intervention are outlined below. The services delivered will be customized based on each patient's case.
1. Medication review and drug therapy optimization
2. Patient education
3. Improving patient adherence Receives: Other: Pharmacist led Asthma Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow Rate (PEF)
A peak flow meter will be used to measure PEF.
Measured: Pharmacist will measure peak flow rate incrementally each month for 12 months total.
Secondary outcomes (9)
Peak Flow Diary
The peak flow diary is a chart given to patients to assist in recording their peak flow measurement using the peak flow meter.
Measured: Patients will measure their peak flow twice daily (morning and night) throughout the duration of the study (i.e., 12 months) with their peak flow meter. They will document their peak flow measurements in a diary.
Asthma Control
The Asthma Control Questionnaire will be used to measure Asthma Control.
Measured: Pharmacist will measure Asthma control twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
The Medication Adherence Report Scale for Asthma
The Medication Adherence Report Scale for Asthma will be used to measure adherence to asthma medication.
Measured: Pharmacist will measure Medication Adherence twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Health Care Service Usage Questionnaire
The Health Care Service Usage Questionnaire will be used to measure a patient's utilization of health care services.
Measured: Pharmacist will measure Health Care Service Usage twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Asthma Quality of Life Questionnaire (AQLQ)
The AQLQ will be used to measure patient's quality of life.
Measured: Pharmacist will measure Asthma related quality of life twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Heath and Work Performance Questionnaire
The Heath and Work Performance Questionnaire will be used to measure patient's presenteeism and absenteeism due to asthma.
Measured: Pharmacist will measure health and work performance twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Asthma Self-Management Questionnaire
The Asthma Self-Management Questionnaire will be used to assess the patient's asthma management techniques.
Measured: Pharmacist will measure Asthma self-management twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Asthma General Knowledge Questionnaire for Adults
The Asthma General Knowledge Questionnaire for Adult will be used to assess patient's asthma knowledge.
Measured: Pharmacist will measure Asthma general knowledge twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Patient Satisfaction Questionnaire
The Patient Satisfaction Questionnaire will be used to assess patients' satisfaction with the services they received over the study duration.
Measured: The pharmacist will distribute this questionnaire to patients at the final appointment (12 months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled AsthmaStudies of the same condition, open and under way.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahava Rosenberg-Yunger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zahava Rosenberg-Yunger, Toronto Metropolitan University
- Investigators
- Zahava Rosenberg-Yunger, PhD, Principal investigator, Ryerson University; Ontario Pharmacists Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768623
- Sponsor's protocol ID
- RyersonU1
- Status last verified
- Aug 2018
- First submitted
- 8 Mar 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Community Pharmacist Managed Asthma Consultation Service
- ClinicalTrials.gov ID
- NCT02768623
- Acronym / sponsor ID
- RyersonU1
- Conditions
- Uncontrolled Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Zahava Rosenberg-YungerUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 11 May 2016 (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.
Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4 million Canadians and over 300 million people worldwide. Unlike most other chronic diseases, asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is also the leading cause of hospitalization for children in Canada and is a significant cause of school and work absenteeism. Though asthma is generally considered a chronic disease, it can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition. Effective management of asthma can prevent exacerbation and more severe negative health consequences. In fact, estimates show that over 80% of the asthma-related deaths could be prevented through proper education. However, evidence also shows that over 55% of patients with moderate to severe asthma do not have their asthma symptoms under control, despite regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma action plan from their physicians, although such plans are associated with fewer ER visits, lower hospitalization rates and improved lung function. Hence, there is a clear opportunity to improve the management of asthma and reduce the incidence of related complications.
Given the scientific evidence of pharmacists effect on asthma management there is a strong rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians suffering from this chronic disease. However, the implementation of such a program should be preceded by a pilot test to ensure that the program parameters are optimized to drive improved patient outcomes and maximum quality of service. The primary goals of this research project are to examine the impact of a pharmacist led asthma management intervention on patient health outcomes and to determine the optimum program structure to ensure quality of service delivery.
This study employs a mixed-methods study design. Investigators will begin with a cluster randomized controlled trial and end with exit interviews.This study will consist of a prospective, randomized controlled trial conducted in the community setting. A total of 12 pharmacies across the Greater Toronto Region will be recruited for this study. Each of these pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. All data will be analyzed using statistical software. Significance level will be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard deviation for the number of patients will be reported. There is a low perceived risk for this study; however, the investigators will take every precaution to ensure this study is conducted in an ethical manner, including protecting patient confidentiality and anonymity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Pharmacist Intervention (when requested by patient)Patients in the control group will receive standard, dispensing services they currently receive from pharmacists. Control group pharmacists will continue to provide these services in accordance with the standards of practice adopted by the Ontario College of Pharmacists. They will not provide either of the 3 intervention components outlined above. Should a control group patient request additional information and/or services, the pharmacist will comply and provide these as deemed necessary for the particular patient. This could include the full range of educational and drug therapy optimization services outlined for the intervention group. If this occurs then the pharmacists will document all services provided in order for the research team to account for this in the analysis. |
| Intervention Group | Experimental | Other: Pharmacist led Asthma ManagementPharmacists in the intervention group will provide patients with a comprehensive disease management program for asthma. The 3 major components of pharmacists' intervention are outlined below. The services delivered will be customized based on each patient's case. 1. Medication review and drug therapy optimization 2. Patient education 3. Improving patient adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provided written consent
- Intending to refill all asthma-related prescriptions at the study pharmacy
- Diagnosed with asthma by a physician or nurse practitioner
- Taking inhaled corticosteroids for which the dose and/or medication has remained unchanged for at least 2 months
- 18 years of age or older
Key exclusion criteria (17 listed)
- Pregnant women
- Unable or unwilling to return to the pharmacy for scheduled visits
- Unable to speak English language well enough to communicate with the pharmacist and complete the questionnaires independently
- Terminal illness or poor prognosis (life expectancy less than 3 years)
- History of alcoholism or drug abuse
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 |
|---|---|---|
| Pharmacist led Asthma ManagementAlso: Pharmacist Asthma Intervention | Other | Intervention Group |
| Pharmacist Intervention (when requested by patient) | Other | Control Group |
Primary outcome
Peak Expiratory Flow Rate (PEF)
Time frame: Pharmacist will measure peak flow rate incrementally each month for 12 months total.
A peak flow meter will be used to measure PEF.
9 secondary outcomes
Peak Flow Diary
Time frame: Patients will measure their peak flow twice daily (morning and night) throughout the duration of the study (i.e., 12 months) with their peak flow meter. They will document their peak flow measurements in a diary.
Asthma Control
Time frame: Pharmacist will measure Asthma control twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
The Medication Adherence Report Scale for Asthma
Time frame: Pharmacist will measure Medication Adherence twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Health Care Service Usage Questionnaire
Time frame: Pharmacist will measure Health Care Service Usage twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Pharmacist will measure Asthma related quality of life twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Heath and Work Performance Questionnaire
Time frame: Pharmacist will measure health and work performance twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Asthma Self-Management Questionnaire
Time frame: Pharmacist will measure Asthma self-management twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Asthma General Knowledge Questionnaire for Adults
Time frame: Pharmacist will measure Asthma general knowledge twice throughout duration of study. First, it will be measured at baseline (month 1) and lastly it will be measured at the final appointment (12 months after baseline).
Patient Satisfaction Questionnaire
Time frame: The pharmacist will distribute this questionnaire to patients at the final appointment (12 months after baseline).
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 28 Aug 2018.
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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.
Zahava Rosenberg-Yunger, PhD principal investigator
Ryerson University; Ontario Pharmacists Association
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist led Asthma Management and Pharmacist Intervention (when requested by patient) in people with Uncontrolled Asthma, run by Zahava Rosenberg-Yunger.
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 6 inclusion and 17 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak Expiratory Flow Rate (PEF) (time frame: Pharmacist will measure peak flow rate incrementally each month for 12 months total.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2018.