AsthmaADEPT4NCT01710059
Using Mobile Phones to Improve Adherence to Inhaled Steroids
A study testing Asthma Supervision, Mobile Phone and Inhaled Corticosteroid Mobile Phone Application in people with Asthma, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study has two main goals. The first goal is to test whether a mobile phone intervention can increase adherence to daily inhaled steroid medications in African American adolescents prescribed this type of medication by his/her asthma doctor. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma Supervision, Mobile Phone and Inhaled Corticosteroid Mobile Phone Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Nov 2013
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 11-16 years of age
- self-identify as African American
- have persistent asthma
- be on a prescription daily inhaled corticosteroid medication for asthma
- be on a prescription inhaled beta2-adrenergic agonist medication for asthma
Who cannot join
- candidate refusal
- the presence of other co-morbidities that could interfere wtih study participation
- > 60% adherence to inhaled corticosteroid medication, measured by the electronic dose counter, during the run-in period
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Refined ADEPT: Human Augmentics for Sustained Wellbeing
This study has two main goals. The first goal is to test whether a mobile phone intervention can increase adherence to daily inhaled steroid medications in African American adolescents prescribed this type of medication by his/her asthma doctor. The second goal is to use a mobile phone intervention to better understand real life patterns of use of quick-relief (beta2-adrenergic agonist) asthma medication in this population.
- Conditions
- Asthma
- Being tested
- Asthma Supervision, Mobile Phone, Inhaled Corticosteroid Mobile Phone Application, Beta2-adrenergic agonist Mobile Phone Application
- Keywords
- Health Status Disparities, Minority Health, Pediatrics, Behavioral Intervention, Cellular Phone, Peer Group
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma SupervisionBehavioural
Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.
Mobile PhoneBehavioural
Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.
Inhaled Corticosteroid Mobile Phone ApplicationBehavioural
The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.
Beta2-adrenergic agonist Mobile Phone ApplicationBehavioural
The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | Experimental: Intervention Group
1) Asthma Supervision; 2) Mobile Phone with talking, texting, and data plan; 3) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 4) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma. Receives: Behavioral: Asthma Supervision; Behavioral: Mobile Phone; Behavioral: Inhaled Corticosteroid Mobile Phone Application; Behavioral: Beta2-adrenergic agonist Mobile Phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter
Adherence is measured as the mean of daily adherence to prescription inhaled corticosteroid dose over 14 days both at baseline and at week 10 of the active treatment phase. For the primary outcome, we will compare adherence at week 10 to adherence at baseline.
Measured: 10 weeks
Secondary outcomes (1)
To understand patterns of use of quick-relief medication for asthma
This study will use an electronic dose counter and mobile phone technology to track participants real time use of quick-relief (beta2-adrenergic agonist) medication for asthma during the 10 weeks of active treatment.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Mosnaim, Rush University Medical Center
- Investigators
- Giselle S. Mosnaim, MD, MS, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710059
- Sponsor's protocol ID
- 10010402
- Other IDs
- 5K23HL092292-04
- Acronym
- ADEPT4
- Status last verified
- Feb 2014
- First submitted
- 16 Oct 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refined ADEPT: Human Augmentics for Sustained Wellbeing
- ClinicalTrials.gov ID
- NCT01710059
- Acronym / sponsor ID
- ADEPT4 / 10010402
- Conditions
- Asthma
- Keywords
- Health Status Disparities, Minority Health, Pediatrics, Behavioral Intervention, Cellular Phone, Peer Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), GlaxoSmithKline
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Oct 2012 (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.
This study has two main goals. The first goal is to test whether a mobile phone intervention can increase adherence to daily inhaled steroid medications in African American adolescents prescribed this type of medication by his/her asthma doctor. The second goal is to use a mobile phone intervention to better understand real life patterns of use of quick-relief (beta2-adrenergic agonist) asthma medication in this population.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Behavioral: Asthma Supervision, Behavioral: Mobile Phone, Behavioral: Inhaled Corticosteroid Mobile Phone Application, Behavioral: Beta2-adrenergic agonist Mobile Phone ApplicationExperimental: Intervention Group 1) Asthma Supervision; 2) Mobile Phone with talking, texting, and data plan; 3) Inhaled Corticosteroid Mobile Phone Application to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated; and 4) Beta2-adrenergic agonist Mobile Phone Application to monitor real time patterns of use of beta2-adrenergic agonist medication for asthma. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 11-16 years of age
- self-identify as African American
- have persistent asthma
- be on a prescription daily inhaled corticosteroid medication for asthma
- be on a prescription inhaled beta2-adrenergic agonist medication for asthma
Key exclusion criteria (3 listed)
- candidate refusal
- the presence of other co-morbidities that could interfere wtih study participation
- > 60% adherence to inhaled corticosteroid medication, measured by the electronic dose counter, during the run-in period
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 |
|---|---|---|
| Asthma SupervisionEach participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication. | Behavioural | Experimental: Intervention Group |
| Mobile PhoneEach participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study. | Behavioural | Experimental: Intervention Group |
| Inhaled Corticosteroid Mobile Phone ApplicationThe Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated. | Behavioural | Experimental: Intervention Group |
| Beta2-adrenergic agonist Mobile Phone ApplicationThe Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication. | Behavioural | Experimental: Intervention Group |
Primary outcome
Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter
Time frame: 10 weeks
Adherence is measured as the mean of daily adherence to prescription inhaled corticosteroid dose over 14 days both at baseline and at week 10 of the active treatment phase. For the primary outcome, we will compare adherence at week 10 to adherence at baseline.
1 secondary outcome
To understand patterns of use of quick-relief medication for asthma
Time frame: 10 weeks
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 12 Feb 2014.
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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.
Giselle S. Mosnaim, MD, MS principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Supervision, Mobile Phone and Inhaled Corticosteroid Mobile Phone Application in people with Asthma, run by Rush University Medical Center 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 5 inclusion and 3 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 12 Feb 2014. 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?
Adherence to inhaled corticosteroids, measured objectively using an electronic dose counter (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2014.