AsthmaNCT02913092
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
A study testing Electronic sensor and OW education in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Electronic sensor and OW education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2017to 23 May 2022
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
- Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
- Use of daily controller inhaler medications
- Adult non-smokers, or lifetime use <5 pack years with no smoking in last 1 yr
- Smartphone required
- English or Spanish speaking
Who cannot join
- No smartphone
- Use of oral corticosteroids in prior 4 weeks
- Pregnancy
- Psychiatric conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control
Read the detailed description
This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.
Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.
- Conditions
- Asthma
- Being tested
- Electronic sensor and OW education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic sensor and OW educationBehavioural
MDI sensor-generated alerts will be relayed via app platform on participant's phone and responded to (e.g. outreach worker contacts the patient for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide education over the phone
| Study group | Role | What they receive |
|---|---|---|
| Electronic sensor and OW education | Experimental | MDI sensor-generated alerts will be relayed and responded to (e.g. outreach worker contacts the participant for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide asthma education over the phone Receives: Behavioral: Electronic sensor and OW education |
| Usual Care | No intervention | Usual care group will receive the electronic tracker but the sensor-generated alerts will not be delivered. If the usual care group rescue inhaler data reveals frequent use of rescue medication (daily use for >3 days) investigators will reach out (via app or phone call) to advise the participant to see their physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test
validated asthma control measure
Measured: change from baseline to 6 months
Secondary outcomes (2)
Medication adherence
measured by electronic sensor
Measured: change from baseline to 6 months
Health care utilization
ED visits and hospitalizations will be assessed via electronic health records
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start17 May 2017
- Primary completion15 Jul 2019
- Study completion23 May 2022
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 Montefiore 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stony Wold-Herbert Fund, Inc.
- Responsible party
- Principal investigator, Marina Reznik, Montefiore Medical Center
- Investigators
- Marina Reznik, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913092
- Sponsor's protocol ID
- 2016-7001
- Other IDs
- Community Service Award
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2016
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT02913092
- Acronym / sponsor ID
- 2016-7001
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Stony Wold-Herbert Fund, Inc.
- Study start
- 17 May 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 23 Sep 2016 (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 will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control
Detailed description
This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.
Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic sensor and OW education | Experimental | Behavioral: Electronic sensor and OW educationMDI sensor-generated alerts will be relayed and responded to (e.g. outreach worker contacts the participant for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide asthma education over the phone |
| Usual Care | No intervention | –Usual care group will receive the electronic tracker but the sensor-generated alerts will not be delivered. If the usual care group rescue inhaler data reveals frequent use of rescue medication (daily use for >3 days) investigators will reach out (via app or phone call) to advise the participant to see their physician |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
- Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
- Use of daily controller inhaler medications
- Adult non-smokers, or lifetime use <5 pack years with no smoking in last 1 yr
- Smartphone required
Key exclusion criteria (4 listed)
- No smartphone
- Use of oral corticosteroids in prior 4 weeks
- Pregnancy
- Psychiatric conditions
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 |
|---|---|---|
| Electronic sensor and OW educationMDI sensor-generated alerts will be relayed via app platform on participant's phone and responded to (e.g. outreach worker contacts the patient for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide education over the phone | Behavioural | Electronic sensor and OW education |
Primary outcome
Asthma Control Test
Time frame: change from baseline to 6 months
validated asthma control measure
2 secondary outcomes
Medication adherence
Time frame: change from baseline to 6 months
Health care utilization
Time frame: change from baseline to 6 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 22 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Marina Reznik, MD, MS principal investigator
Montefiore 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 Electronic sensor and OW education in people with Asthma, run by Montefiore 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 6 inclusion and 4 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 22 Aug 2022. 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?
Asthma Control Test (time frame: change from baseline to 6 months). 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 22 Aug 2022.