STudy of Asthma Adherence Reminders (STAAR)

November 20, 2015 updated by: Sheffield Children's NHS Foundation Trust

Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?

To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Sheffield (South Yorkshire district)
      • Sheffield, Sheffield (South Yorkshire district), United Kingdom, S10 2TH
        • Sheffield Children's NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Electronic adherence monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
6 months
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.
9 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Recorded at baseline, 3, 6, 9 and 12 months.
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.
Recorded at baseline
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.
Recorded at baseline, 3, 6, 9 and 12 months.
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.
Recorded at baseline, 3, 6, 9 and 12 months.
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.
Recorded at baseline, 3, 6, 9 and 12 months.
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
Recorded at baseline, 3, 6, 9 and 12 months.
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.
Recorded at baseline, 3, 6, 9 and 12 months.
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.
Recorded at baseline
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.
Recorded at baseline, 3, 6, 9 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Investigators

  • Principal Investigator: Robert Morton, Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH/13/041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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