AsthmaNCT03847142
An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
A study testing ASTHMAXcel mobile application and Outpatient primary care in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- ASTHMAXcel mobile application and Outpatient primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking individuals >18 years with:
- persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
- able to give informed consent
- Smartphone (iOS or Android) access
Who cannot join
- use of oral corticosteroids in the 2 weeks prior to the baseline visit
- pregnancy
- severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
- patients that previously received ASTHMAXcel
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: Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.
Read the detailed description
Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.
- Conditions
- Asthma
- Being tested
- ASTHMAXcel mobile application, Outpatient primary care
- Keywords
- informatics, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTHMAXcel mobile applicationOther
ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.
Outpatient primary careOther
Usual care delivered through the outpatient primary care setting
| Study group | Role | What they receive |
|---|---|---|
| ASTHMAXcel arm | Experimental | The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma. Receives: Other: ASTHMAXcel mobile application |
| Usual care arm | Active comparator | This arm represents usual care delivered in the outpatient primary care setting at the study sites. Receives: Other: Outpatient primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline asthma quality of life to 2, 6, and 12 months
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
Measured: Baseline, 2 months, 6 months, 12 months
Secondary outcomes (8)
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Measured: Baseline, 2 months, 6 months, 12 months
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Measured: Baseline, 2 months, 6 months, 12 months
Change from baseline asthma knowledge to 2 months, 6 months, and 12 months
Asthma knowledge as measured by the validated KASE asthma questionnaire
Measured: Baseline, 2 months, 6 months, 12 months
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Measured: Baseline, 2 months, 6 months, 12 months
Change from baseline asthma control to 2, 6, and 12 months
Asthma symptom burden as measured by the Asthma Control Test
Measured: Baseline, 2 months, 6 months, 12 months
Depression as measured by the Patient Health Questionnaire-9
Depression as measured by the Patient Health Questionnaire-9
Measured: Baseline, 2 months, 6 months, 12 months
Number of asthma emergency department visits
Number of asthma emergency department visits
Measured: Baseline, 2 months, 6 months, 12 months
Number of asthma hospitalizations
Number of asthma hospitalizations
Measured: Baseline, 2 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Mar 2020
- Primary completion1 May 2023
- Study completion1 May 2023
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 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
- Model description
- Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunit Jariwala, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847142
- Sponsor's protocol ID
- 2018-9027
- Other IDs
- R18HS025645
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2019
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silverstein GD, Styke SC, Kaur S, Singh A, Green S, Jariwala SP, Feldman J. The Relationship Between Depressive Symptoms, eHealth Literacy, and Asthma Outcomes in the Context of a Mobile Health Intervention. Psychosom Med. 2023 Sep 1;85(7):605-611. doi: 10.1097/PSY.0000000000001170. Epub 2023 Jan 27.
PubMed 36799736
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
- ClinicalTrials.gov ID
- NCT03847142
- Acronym / sponsor ID
- 2018-9027
- Conditions
- Asthma
- Keywords
- informatics, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 20 Feb 2019 (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.
Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.
Detailed description
Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.
| Arm | Type | Receives |
|---|---|---|
| ASTHMAXcel arm | Experimental | Other: ASTHMAXcel mobile applicationThe ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma. |
| Usual care arm | Active comparator | Other: Outpatient primary careThis arm represents usual care delivered in the outpatient primary care setting at the study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
- able to give informed consent
- Smartphone (iOS or Android) access
Key exclusion criteria (4 listed)
- use of oral corticosteroids in the 2 weeks prior to the baseline visit
- pregnancy
- severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
- patients that previously received ASTHMAXcel
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 |
|---|---|---|
| ASTHMAXcel mobile applicationASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education. | Other | ASTHMAXcel arm |
| Outpatient primary careUsual care delivered through the outpatient primary care setting | Other | Usual care arm |
Primary outcome
Change from baseline asthma quality of life to 2, 6, and 12 months
Time frame: Baseline, 2 months, 6 months, 12 months
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
8 secondary outcomes
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time frame: Baseline, 2 months, 6 months, 12 months
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Time frame: Baseline, 2 months, 6 months, 12 months
Change from baseline asthma knowledge to 2 months, 6 months, and 12 months
Time frame: Baseline, 2 months, 6 months, 12 months
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Time frame: Baseline, 2 months, 6 months, 12 months
Change from baseline asthma control to 2, 6, and 12 months
Time frame: Baseline, 2 months, 6 months, 12 months
Depression as measured by the Patient Health Questionnaire-9
Time frame: Baseline, 2 months, 6 months, 12 months
Number of asthma emergency department visits
Time frame: Baseline, 2 months, 6 months, 12 months
Number of asthma hospitalizations
Time frame: Baseline, 2 months, 6 months, 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 7 Jun 2023.
- Derived from this study: PubMed 36799736Silverstein GD, Styke SC, Kaur S, Singh A, Green S, Jariwala SP, Feldman J. The Relationship Between Depressive Symptoms, eHealth Literacy, and Asthma Outcomes in the Context of a Mobile Health Intervention. Psychosom Med. 2023 Sep 1;85(7):605-611. doi: 10.1097/PSY.0000000000001170. Epub 2023 Jan 27.
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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.
Sunit Jariwala 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 ASTHMAXcel mobile application and Outpatient primary care 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 4 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 7 Jun 2023. 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 from baseline asthma quality of life to 2, 6, and 12 months (time frame: Baseline, 2 months, 6 months, 12 months). 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 NCT03847142, 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 7 Jun 2023.