Effectiveness of Pharmacist Interventions in Difficult Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmacist intervention and pharmacist support
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma focused on measuring Pharmacy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of asthma
- Fulfil the criteria for difficult asthma (defined as persistent symptoms and/or frequent exacerbations despite treatment at step 4 or step 5 of the British TYhoracic Society / SIGN asthma guidelines 2011)
- Adult patients age between 18 and 70 years
- Able to speak, read and write in English
- All patients must have received their regular medication from the same Community Pharmacy for at least 3 months prior to their baseline visit
- Their community pharmacy must be registered with Leeds Primary Care Trust(PCT) to undertake targeted Medicines Use Reviews (tMURs).
Exclusion Criteria:
- Failure to meet the inclusion criteria
- Patient is not responsible for administering their own medications
- Patient is unlikely to be available for the 6-month follow-up period
- Failure to provide written informed consent
- Patient has had an MUR within the 12 months preceding the study period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacist Intervention Group
Usual Care Group
Arm Description
Outcomes
Primary Outcome Measures
Improvement in Asthma Control, using Juiper's Asthma Control Questionnaire (ACQ).
Secondary Outcome Measures
Full Information
NCT ID
NCT02363192
First Posted
February 9, 2015
Last Updated
February 12, 2015
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02363192
Brief Title
Effectiveness of Pharmacist Interventions in Difficult Asthma
Official Title
The Effectiveness of Pharmacist Interventions in Improving Asthma Control and Quality of Life in Patients With Difficult Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Of the 5.2 million people with asthma in the UK, approximately one in every 40 have severe asthma that needs the maximum available treatments advised in national asthma guidelines (known as the 'British Thoracic Society / Scottish Intercollegiate Guidelines Network British Guideline on the Management of Asthma'). Despite this, asthma is still inadequately controlled in about half of these patients and they are classed as having 'difficult asthma'. There maybe potential for improvement of the care and health of these patients through better use of medicines and greater input from pharmacists, but more research is needed.
The aim of the study is to measure the effects over six months of coordinated information and advice about medicines from hospital and community pharmacists on asthma control in patients with difficult asthma. The patients in the study (52 in total) will be recruited from adult patients attending a specialist difficult asthma clinic in a hospital.
Patients will be randomly chosen to have either an appointment with the specialist pharmacist (intervention group), or usual medical care (control group). Usual care will involve seeing the Consultant or Specialist Registrar (doctor) in the clinic. Patients in the intervention group will receive i) assessment and education on asthma, and review of their inhaler technique, from a hospital Advanced Clinical Pharmacist and ii) will also be referred for a medicines use review from their usual community pharmacist (chemist), to take place 1-2 months after their hospital clinic appointment. The Advanced Clinical Pharmacist will be working closely with the Consultant.
Results will be measured using methods that have been developed by experts in asthma and tested in previous research. Asthma control will be measured using Juniper's Asthma Control Questionnaire. Other measurements will cover quality of life, use of medication, use of healthcare resources, and inhaler technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pharmacy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Intervention Group
Arm Type
Experimental
Arm Title
Usual Care Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist intervention and pharmacist support
Intervention Description
Patients randomised to this group will undergo an asthma assessment to assess asthma control, adherence and inhaler technique, by an Advanced Clinical Pharmacist specialising in Respiratory Medicine.
Primary Outcome Measure Information:
Title
Improvement in Asthma Control, using Juiper's Asthma Control Questionnaire (ACQ).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of asthma
Fulfil the criteria for difficult asthma (defined as persistent symptoms and/or frequent exacerbations despite treatment at step 4 or step 5 of the British TYhoracic Society / SIGN asthma guidelines 2011)
Adult patients age between 18 and 70 years
Able to speak, read and write in English
All patients must have received their regular medication from the same Community Pharmacy for at least 3 months prior to their baseline visit
Their community pharmacy must be registered with Leeds Primary Care Trust(PCT) to undertake targeted Medicines Use Reviews (tMURs).
Exclusion Criteria:
Failure to meet the inclusion criteria
Patient is not responsible for administering their own medications
Patient is unlikely to be available for the 6-month follow-up period
Failure to provide written informed consent
Patient has had an MUR within the 12 months preceding the study period.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Pharmacist Interventions in Difficult Asthma
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