STudy of Asthma Adherence Reminders

Not Applicable

Completed

• Conditions: Childhood Asthma

• Registration Number: NCT02451709
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Status Verified: 2015-05
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in asthma control from baseline at 9 months	9 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Change in asthma control from baseline at 3 months	3 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Change in asthma control from baseline at 6 months	6 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Change in asthma control from baseline at 12 months	12 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.

Secondary Outcome Measures

Name	Time	Method
Medication beliefs	Recorded at baseline	As measured by the "beliefs about medicines" questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids.
Rescue beta-agonist use	Recorded at baseline, 3, 6, 9 and 12 months.	Question score on the ACQ regarding recent beta agonist use.
Forced Expiratory Volume in 1 second (FEV1) - % predicted	Recorded at baseline, 3, 6, 9 and 12 months.	% predicted value compared with Global Lung Initiative 2012 reference values.
Unplanned GP/ ED attendances for asthma	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.
Adherence to ICS treatment	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.
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	Recorded at baseline, 3, 6, 9 and 12 months.	Dose of ICS
Rescue doses of oral steroids	Recorded at baseline, 3, 6, 9 and 12 months.	Number of rescue doses of oral steroids required in the previous 3 months.
Asthma-related quality of life, as measured by the "Mini Paediatric Asthma Quality of Life Questionnaire" (Mini PAQLQ)	Recorded at baseline, 3, 6, 9 and 12 months.	Mean score of 0-7, lower score indicating poorer asthma - related quality of life.
Parents' illness perceptions as measured by the "brief illness perception questionnaire.	Recorded at baseline	As measured by the "brief illness perception questionnaire. A higher score indicates a more threatening view of the illness.

Trial Locations

Locations (1)

Sheffield Children's NHS Foundation Trust; 🇬🇧 Sheffield, Sheffield (South Yorkshire district), United Kingdom