AsthmaNCT02363192
Effectiveness of Pharmacist Interventions in Difficult Asthma
A study testing Pharmacist intervention and pharmacist support in people with Asthma, run by The Leeds Teaching Hospitals NHS Trust.
Trial 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'). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pharmacist intervention and pharmacist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: The Effectiveness of Pharmacist Interventions in Improving Asthma Control and Quality of Life in Patients With Difficult Asthma
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.
Read more
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.
- Conditions
- Asthma
- Being tested
- Pharmacist intervention and pharmacist support
- Keywords
- Pharmacy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist intervention and pharmacist supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Intervention Group | Experimental | Not described Receives: Behavioral: Pharmacist intervention and pharmacist support |
| Usual Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Asthma Control, using Juiper's Asthma Control Questionnaire (ACQ).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363192
- Sponsor's protocol ID
- PH10/9328
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Pharmacist Interventions in Improving Asthma Control and Quality of Life in Patients With Difficult Asthma
- ClinicalTrials.gov ID
- NCT02363192
- Acronym / sponsor ID
- PH10/9328
- Conditions
- Asthma
- Keywords
- Pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Feb 2015 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Intervention Group | Experimental | Behavioral: Pharmacist intervention and pharmacist support |
| Usual Care Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 intervention and pharmacist supportPatients 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. | Behavioural | Pharmacist Intervention Group |
Primary outcome
Improvement in Asthma Control, using Juiper's Asthma Control Questionnaire (ACQ).
Time frame: 6 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 13 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist intervention and pharmacist support in people with Asthma, run by The Leeds Teaching Hospitals NHS Trust.
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 5 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 13 Feb 2015. 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?
Improvement in Asthma Control, using Juiper's Asthma Control Questionnaire (ACQ). (time frame: 6 months). 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 13 Feb 2015.