Childhood AsthmaSTAARNCT02451709
STudy of Asthma Adherence Reminders
A study testing Activated Smartinhaler or Smartturbo, Feedback of adherence data and Deactivated Smartinhaler or Smartturbo in people with Childhood Asthma, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- Activated Smartinhaler or Smartturbo, Feedback of adherence data and Deactivated Smartinhaler or Smartturbo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.
Read the 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.
- Conditions
- Childhood Asthma
- Being tested
- Activated Smartinhaler or Smartturbo, Feedback of adherence data, Deactivated Smartinhaler or Smartturbo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated Smartinhaler or SmartturboDevice
Also called Electronic adherence monitor
Medication reminder alarms
Feedback of adherence dataOther
Review of adherence data with action planning
Deactivated Smartinhaler or SmartturboDevice
Also called Electronic adherence monitor
Alarms deactivated and no feedback
| Study group | Role | What they receive |
|---|---|---|
| Feedback and alarms | Experimental | 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. Receives: Device: Activated Smartinhaler or Smartturbo; Other: Feedback of adherence data |
| No feedback or alarms | Active comparator | 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. Receives: Device: Deactivated Smartinhaler or Smartturbo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
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.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
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.
Measured: Recorded at baseline
Unplanned GP/ ED attendances for asthma
Number of unplanned visits to GP or A\&E for asthma in the previous 3 months.
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
Rescue beta-agonist use
Question score on the ACQ regarding recent beta agonist use.
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
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.
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
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
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
Forced Expiratory Volume in 1 second (FEV1) - % predicted
% predicted value compared with Global Lung Initiative 2012 reference values.
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
Medication beliefs
As measured by the "beliefs about medicines" questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids.
Measured: Recorded at baseline
Rescue doses of oral steroids
Number of rescue doses of oral steroids required in the previous 3 months.
Measured: Recorded at baseline, 3, 6, 9 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Morton, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451709
- Sponsor's protocol ID
- SCH/13/041
- Acronym
- STAAR
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27815524
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
- ClinicalTrials.gov ID
- NCT02451709
- Acronym / sponsor ID
- STAAR / SCH/13/041
- Conditions
- Childhood Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback and alarms | Experimental | Device: Activated Smartinhaler or Smartturbo, Other: Feedback of adherence dataStandard 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. |
| No feedback or alarms | Active comparator | Device: Deactivated Smartinhaler or SmartturboStandard 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated Smartinhaler or SmartturboAlso: Electronic adherence monitorMedication reminder alarms | Device | Feedback and alarms |
| Feedback of adherence dataReview of adherence data with action planning | Other | Feedback and alarms |
| Deactivated Smartinhaler or SmartturboAlso: Electronic adherence monitorAlarms deactivated and no feedback | Device | No feedback or alarms |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
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.
Parents' illness perceptions as measured by the "brief illness perception questionnaire.
Time frame: Recorded at baseline
Unplanned GP/ ED attendances for asthma
Time frame: Recorded at baseline, 3, 6, 9 and 12 months.
Rescue beta-agonist use
Time frame: Recorded at baseline, 3, 6, 9 and 12 months.
Adherence to ICS treatment
Time frame: Recorded at baseline, 3, 6, 9 and 12 months.
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.
Forced Expiratory Volume in 1 second (FEV1) - % predicted
Time frame: Recorded at baseline, 3, 6, 9 and 12 months.
Medication beliefs
Time frame: Recorded at baseline
Rescue doses of oral steroids
Time frame: Recorded at baseline, 3, 6, 9 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Derived from this study: PubMed 27815524Morton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Morton principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated Smartinhaler or Smartturbo, Feedback of adherence data and Deactivated Smartinhaler or Smartturbo in people with Childhood Asthma, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma control from baseline at 3 months (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.