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OpenTrials
Completed

NCT Number: NCT02451709

STudy of Asthma Adherence Reminders

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

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Key information

Conditions

Childhood Asthma

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activated Smartinhaler or Smartturbo

Device

Medication reminder alarms

Other names: Electronic adherence monitor

Feedback of adherence data

Other

Review of adherence data with action planning

Deactivated Smartinhaler or Smartturbo

Device

Alarms deactivated and no feedback

Other names: Electronic adherence monitor

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: STAAR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 22, 2015
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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