Clinical trial NCT02451709: STudy of Asthma Adherence Reminders
Official title: Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in asthma control from baseline at 3 months
timeFrame: 3 months
measure: Change in asthma control from baseline at 6 months
timeFrame: 6 months
measure: Change in asthma control from baseline at 9 months
timeFrame: 9 months
measure: Change in asthma control from baseline at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Asthma-related quality of life, as measured by the "Mini Paediatric Asthma Quality of Life Questionnaire" (Mini PAQLQ)
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
measure: Parents' illness perceptions as measured by the "brief illness perception questionnaire.
timeFrame: Recorded at baseline
measure: Unplanned GP/ ED attendances for asthma
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
measure: Rescue beta-agonist use
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
measure: Adherence to ICS treatment
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
measure: 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
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
measure: Forced Expiratory Volume in 1 second (FEV1) - % predicted
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
measure: Medication beliefs
timeFrame: Recorded at baseline
measure: Rescue doses of oral steroids
timeFrame: Recorded at baseline, 3, 6, 9 and 12 months.
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: Sheffield (South Yorkshire district)
Study officials:
affiliation: Investigator
name: Robert Morton
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morton RW, Elphick HE, Rigby AS, Daw WJ, King DA, Smith LJ, Everard ML. STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma. Thorax. 2017 Apr;72(4):347-354. doi: 10.1136/thoraxjnl-2015-208171. Epub 2016 Nov 4.