AsthmaNCT03515499
Incentives for Adherence in Adolescent Asthma
A study testing Incentives and Medication device monitoring and reminders in people with Asthma and Asthma in Children, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- Incentives and Medication device monitoring and reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2018to 5 Feb 2020
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- physician diagnosed asthma
- on at least one inhaled controller medication
Who cannot join
- language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
- other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incentives for Medication Adherence in Adolescents With Asthma
Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.
Read the detailed description
Two groups will be enrolled. The control group will have mediation monitoring sensors placed on their controller inhalers. The treatment group will also have the monitoring sensors placed on their medications, however they will be paid up to $1 per day for perfect adherence for 3 months. Both groups will be monitored for 4 months. 10 subjects will be chosen from each group to complete semi-structured phone interviews
- Conditions
- Asthma, Asthma in Children
- Being tested
- Incentives, Medication device monitoring and reminders
- Keywords
- Adherence, Incentives
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncentivesBehavioural
Subjects in the treatment arm will be paid up to $1 per day over 3 months for perfect medication adherence. Adherence rates will then be compared between the 2 groups.
Medication device monitoring and remindersBehavioural
Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. Receives: Behavioral: Medication device monitoring and reminders |
| Treatment arm | Experimental | The treatment arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. Additionally, they will be paid up to $1 per day for perfect medication adherence. Receives: Behavioral: Incentives; Behavioral: Medication device monitoring and reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence rates
This Outcome will measure the difference in adherence at the end of the study period between the 2 groups as measured by the adherence devices (calculated as percent adherence per week over the 12 week study period).
Measured: Daily for 12 weeks
Secondary outcomes (3)
Changes in Qualitative outcomes - Barriers
Qualitative methodology will be used to evaluate patient attitudes towards the incentive program, as well as barriers of adherence, using semi-structured interviews. The investigators will obtain information on attitudes regarding barriers to medication adherence
Measured: After 3 months of monitoring
Changes in Qualitative outcomes - Facilitators
Qualitative methodology will be used to evaluate patient attitudes towards the incentive program, as well as facilitators of adherence, using semi-structured interviews. The investigators will obtain information on attitudes regarding facilitators to adequate medication adherence.
Measured: After 3 months of monitoring
Changes in Qualitative outcomes - Incentives
Qualitatively assessed feelings regarding incentives
Qualitative methodology will be used to evaluate patient feelings towards the incentive program.The investigators will obtain information on incentives to adequate medication adherence.
Measured: After 3 months of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start6 Jul 2018
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
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 AsthmaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Hoch, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515499
- Sponsor's protocol ID
- 18-0089
- Status last verified
- Jun 2020
- First submitted
- 5 Feb 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers
Publications
Keyser HH, Brinton JT, Bothwell S, Camacho M, Kempe A, Szefler SJ. Encouraging adherence in adolescents with asthma using financial incentives: An RCT. Pediatr Pulmonol. 2023 Oct;58(10):2823-2831. doi: 10.1002/ppul.26594. Epub 2023 Jul 14.
PubMed 37449768
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives for Medication Adherence in Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT03515499
- Acronym / sponsor ID
- 18-0089
- Conditions
- Asthma, Asthma in Children
- Keywords
- Adherence, Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 3 May 2018 (actual)
- 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.
Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.
Detailed description
Two groups will be enrolled. The control group will have mediation monitoring sensors placed on their controller inhalers. The treatment group will also have the monitoring sensors placed on their medications, however they will be paid up to $1 per day for perfect adherence for 3 months. Both groups will be monitored for 4 months. 10 subjects will be chosen from each group to complete semi-structured phone interviews
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Medication device monitoring and remindersThe control arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. |
| Treatment arm | Experimental | Behavioral: Incentives, Behavioral: Medication device monitoring and remindersThe treatment arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. Additionally, they will be paid up to $1 per day for perfect medication adherence. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- physician diagnosed asthma
- on at least one inhaled controller medication
Key exclusion criteria (2 listed)
- language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
- other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.
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 |
|---|---|---|
| IncentivesSubjects in the treatment arm will be paid up to $1 per day over 3 months for perfect medication adherence. Adherence rates will then be compared between the 2 groups. | Behavioural | Treatment arm |
| Medication device monitoring and remindersBluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use. | Behavioural | Control, Treatment arm |
Primary outcome
Change in adherence rates
Time frame: Daily for 12 weeks
This Outcome will measure the difference in adherence at the end of the study period between the 2 groups as measured by the adherence devices (calculated as percent adherence per week over the 12 week study period).
3 secondary outcomes
Changes in Qualitative outcomes - Barriers
Time frame: After 3 months of monitoring
Changes in Qualitative outcomes - Facilitators
Time frame: After 3 months of monitoring
Changes in Qualitative outcomes - Incentives
Time frame: After 3 months of monitoring
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 11 Jun 2020.
- Derived from this study: PubMed 37449768Keyser HH, Brinton JT, Bothwell S, Camacho M, Kempe A, Szefler SJ. Encouraging adherence in adolescents with asthma using financial incentives: An RCT. Pediatr Pulmonol. 2023 Oct;58(10):2823-2831. doi: 10.1002/ppul.26594. Epub 2023 Jul 14.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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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.
Heather Hoch, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives and Medication device monitoring and reminders in people with Asthma and Asthma in Children, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 2 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 11 Jun 2020. 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 States. 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 adherence rates (time frame: Daily for 12 weeks). 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 NCT03515499, 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 11 Jun 2020.