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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
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Pharmacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 9, 2015
    Last Updated
    February 12, 2015
    Sponsor
    The Leeds Teaching Hospitals NHS Trust
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    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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