STudy of Asthma Adherence Reminders

Childhood Asthma Clinical Trial

— STAAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451709
• Other study ID #: SCH/13/041
• Status: Completed
• Phase: N/A
• First received: May 5, 2015
• Last updated: November 20, 2015
• Start date: October 2013
• Est. completion date: November 2015

Study information

• Verified date: May 2015
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Device:
• Activated Smartinhaler or Smartturbo
Medication reminder alarms

Other:
• Feedback of adherence data
Review of adherence data with action planning

Device:
• Deactivated Smartinhaler or Smartturbo
Alarms deactivated and no feedback

Locations

Country	Name	City	State
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	Sheffield (South Yorkshire district)

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in asthma control from baseline at 3 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.	3 months	No
Primary	Change in asthma control from baseline at 6 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.	6 months	No
Primary	Change in asthma control from baseline at 9 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.	9 months	No
Primary	Change in asthma control from baseline at 12 months	Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.	12 months	No
Secondary	Asthma-related quality of life, as measured by the "Mini Paediatric Asthma Quality of Life Questionnaire" (Mini PAQLQ)	Mean score of 0-7, lower score indicating poorer asthma - related quality of life.	Recorded at baseline, 3, 6, 9 and 12 months.	No
Secondary	Parents' illness perceptions as measured by the "brief illness perception questionnaire.	As measured by the "brief illness perception questionnaire. A higher score indicates a more threatening view of the illness.	Recorded at baseline	No
Secondary	Unplanned GP/ ED attendances for asthma	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.	No
Secondary	Rescue beta-agonist use	Question score on the ACQ regarding recent beta agonist use.	Recorded at baseline, 3, 6, 9 and 12 months.	No
Secondary	Adherence to ICS treatment	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.	No
Secondary	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	Dose of ICS	Recorded at baseline, 3, 6, 9 and 12 months.	No
Secondary	Forced Expiratory Volume in 1 second (FEV1) - % predicted	% predicted value compared with Global Lung Initiative 2012 reference values.	Recorded at baseline, 3, 6, 9 and 12 months.	No
Secondary	Medication beliefs	As measured by the "beliefs about medicines" questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids.	Recorded at baseline	No
Secondary	Rescue doses of oral steroids	Number of rescue doses of oral steroids required in the previous 3 months.	Recorded at baseline, 3, 6, 9 and 12 months.	No