search
Back to results

STudy of Asthma Adherence Reminders (STAAR)

Primary Purpose

Childhood Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Activated Smartinhaler or Smartturbo
Feedback of adherence data
Deactivated Smartinhaler or Smartturbo
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Asthma

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheffield Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Feedback and alarms

No feedback or alarms

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Unplanned GP/ ED attendances for asthma
Number of unplanned visits to GP or A&E for asthma in the previous 3 months.
Rescue beta-agonist use
Question score on the ACQ regarding recent beta agonist use.
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.
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
Forced Expiratory Volume in 1 second (FEV1) - % predicted
% predicted value compared with Global Lung Initiative 2012 reference values.
Medication beliefs
As measured by the "beliefs about medicines" questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids.
Rescue doses of oral steroids
Number of rescue doses of oral steroids required in the previous 3 months.

Full Information

First Posted
May 5, 2015
Last Updated
November 20, 2015
Sponsor
Sheffield Children's NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02451709
Brief Title
STudy of Asthma Adherence Reminders
Acronym
STAAR
Official Title
Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback and alarms
Arm Type
Experimental
Arm Description
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.
Arm Title
No feedback or alarms
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Activated Smartinhaler or Smartturbo
Other Intervention Name(s)
Electronic adherence monitor
Intervention Description
Medication reminder alarms
Intervention Type
Other
Intervention Name(s)
Feedback of adherence data
Intervention Description
Review of adherence data with action planning
Intervention Type
Device
Intervention Name(s)
Deactivated Smartinhaler or Smartturbo
Other Intervention Name(s)
Electronic adherence monitor
Intervention Description
Alarms deactivated and no feedback
Primary Outcome Measure Information:
Title
Change in asthma control from baseline at 3 months
Description
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Time Frame
3 months
Title
Change in asthma control from baseline at 6 months
Description
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Time Frame
6 months
Title
Change in asthma control from baseline at 9 months
Description
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Time Frame
9 months
Title
Change in asthma control from baseline at 12 months
Description
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Asthma-related quality of life, as measured by the "Mini Paediatric Asthma Quality of Life Questionnaire" (Mini PAQLQ)
Description
Mean score of 0-7, lower score indicating poorer asthma - related quality of life.
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.
Title
Parents' illness perceptions as measured by the "brief illness perception questionnaire.
Description
As measured by the "brief illness perception questionnaire. A higher score indicates a more threatening view of the illness.
Time Frame
Recorded at baseline
Title
Unplanned GP/ ED attendances for asthma
Description
Number of unplanned visits to GP or A&E for asthma in the previous 3 months.
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.
Title
Rescue beta-agonist use
Description
Question score on the ACQ regarding recent beta agonist use.
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.
Title
Adherence to ICS treatment
Description
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.
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.
Title
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
Description
Dose of ICS
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.
Title
Forced Expiratory Volume in 1 second (FEV1) - % predicted
Description
% predicted value compared with Global Lung Initiative 2012 reference values.
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.
Title
Medication beliefs
Description
As measured by the "beliefs about medicines" questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids.
Time Frame
Recorded at baseline
Title
Rescue doses of oral steroids
Description
Number of rescue doses of oral steroids required in the previous 3 months.
Time Frame
Recorded at baseline, 3, 6, 9 and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Morton
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire district)
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27815524
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.
Results Reference
derived

Learn more about this trial

STudy of Asthma Adherence Reminders

We'll reach out to this number within 24 hrs