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STudy of Asthma Adherence Reminders (STAAR)

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ClinicalTrials.gov Identifier: NCT02451709
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

Study Description
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Brief Summary:
To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.

Condition or disease Intervention/treatment Phase
Childhood Asthma Device: Activated Smartinhaler or Smartturbo Other: Feedback of adherence data Device: Deactivated Smartinhaler or Smartturbo Not Applicable

Detailed Description:
This study will investigate whether adding an electronic adherence monitor to inhaled steroids, and feeding this information back to patients and families can improve adherence and outcomes in childhood asthma. The devices will also sound twice daily reminder alarms to act as direct medication prompts. This intervention will be compared to a control group in which adherence is monitored, but with no feedback or alarms.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Feedback and alarms

Standard education about importance of inhaled steroids and regular adherence to inhaled steroids after recruitment to study.

Randomized to receive an electronic adherence device ( activated smartinhaler or smartturbo - Nexus 6) with twice daily alarm reminders activated. Patient decides times, different times on weekdays and weekends if required. This device fitted to their regular preventer inhaler, patient aware of its presence and its purpose in the context of the study.

Reviewed in standard asthma clinic every 3 months for 12 months. At each clinic visit, adherence information downloaded from device and data shared with patient and family (feedback of adherence data). Discussion about adherence rates, and action planning for the next 3 months to improve adherence if necessary.

 Device: Activated Smartinhaler or Smartturbo
Medication reminder alarms
Other Name: Electronic adherence monitor

Other: Feedback of adherence data
Review of adherence data with action planning
Active Comparator: No feedback or alarms

Standard education about importance of inhaled steroids and regular adherence to inhaled steroids after recruitment to study.

Randomized to receive an electronic adherence device. Deactivated Smartinhaler or Smartturbo.

Device not activated to play reminder alarms. This device fitted to their regular preventer inhaler, patient aware of its presence and its purpose in the context of the study.

Reviewed in standard asthma clinic every 3 months for 12 months. At each clinic visit, adherence information downloaded from device but data not shared with patient, and no adherence discussion.

 Device: Deactivated Smartinhaler or Smartturbo
Alarms deactivated and no feedback
Other Name: Electronic adherence monitor


Outcome Measures
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Primary Outcome Measures :
  1. Change in asthma control from baseline at 3 months [ Time Frame: 3 months ]
    Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.

  2. Change in asthma control from baseline at 6 months [ Time Frame: 6 months ]
    Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.

  3. Change in asthma control from baseline at 9 months [ Time Frame: 9 months ]
    Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.

  4. Change in asthma control from baseline at 12 months [ Time Frame: 12 months ]
    Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.


Secondary Outcome Measures :
  1. Asthma-related quality of life, as measured by the "Mini Paediatric Asthma Quality of Life Questionnaire" (Mini PAQLQ) [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    Mean score of 0-7, lower score indicating poorer asthma - related quality of life.

  2. Parents' illness perceptions as measured by the "brief illness perception questionnaire. [ Time Frame: Recorded at baseline ]
    As measured by the "brief illness perception questionnaire. A higher score indicates a more threatening view of the illness.

  3. Unplanned GP/ ED attendances for asthma [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    Number of unplanned visits to GP or A&E for asthma in the previous 3 months.

  4. Rescue beta-agonist use [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    Question score on the ACQ regarding recent beta agonist use.

  5. Adherence to ICS treatment [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    Electronic adherence rate as measured by the smartinhaler or smartturbo. Adherence rate calculated as percentage of prescribed doses actually taken. Adherence rate capped at 100% for any single day.

  6. Level of maintenance asthma therapy. Treatment level (modified BTS step) at 12 months and individual change in modified BTS step between baseline and 12 months [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    Dose of ICS

  7. Forced Expiratory Volume in 1 second (FEV1) - % predicted [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    % predicted value compared with Global Lung Initiative 2012 reference values.

  8. Medication beliefs [ Time Frame: Recorded at baseline ]
    As measured by the "beliefs about medicines" questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids.

  9. Rescue doses of oral steroids [ Time Frame: Recorded at baseline, 3, 6, 9 and 12 months. ]
    Number of rescue doses of oral steroids required in the previous 3 months.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Doctor diagnosed asthma.
  • On at least BTS stage 2, which means they will be on regular inhaled steroids.

  • No change in regular asthma treatment in the last 1 month (on regular inhaled steroids, no change in steroid dose for

    1 month, no change in add on therapy in the last month).

  • ACQ (Asthma Control Questionnaire) score more than or equal to 1.5.
  • Can speak and understand English.

Exclusion Criteria:

  • BTS stage 5 asthma (complex issues, too unstable).
  • Recent changes to asthma treatment within the last month. (see above)
  • ACQ (Asthma Control Questionnaire) score < 1.5.
  • Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis).
  • Can't speak or understand English.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451709


Locations
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United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire district), United Kingdom, S10 2TH
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
Investigators
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Principal Investigator: Robert Morton Investigator
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02451709    
Other Study ID Numbers: SCH/13/041
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases