AsthmaNCT06159127
SMART@Home Feasibility Trial
A study testing SMART@Home in people with Asthma and Asthma in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- SMART@Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
- Ages 12-18
- English fluency for patient and caregiver
Who cannot join
- Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Kevin, PhD
About this study
Official title: Self-Management Assistance for Recommended Treatment (SMART)@Home Care
The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.
Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.
A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.
- Conditions
- Asthma, Asthma in Children
- Being tested
- SMART@Home
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART@HomeBehavioural
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
| Study group | Role | What they receive |
|---|---|---|
| SMART@Home | Experimental | Use of the SMART@Home app for medication and symptom tracking, spirometry feedback Receives: Behavioral: SMART@Home |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Monthly adherence will be calculated by comparing doses taken to doses recommended by IMAAP. Participants will also report rescue medication use each month when completing the ACT.
Measured: 6 months
Number of days app used
Number of diaries completed by participant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start9 Sep 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Hommel, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiRachelle Ramsey, PhD, Study chair, Children's Hospital Medical Center, CincinnatiMatt Wortman, PhD, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159127
- Sponsor's protocol ID
- SMART@Home
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Assistance for Recommended Treatment (SMART)@Home Care
- ClinicalTrials.gov ID
- NCT06159127
- Acronym / sponsor ID
- SMART@Home
- Conditions
- Asthma, Asthma in Children
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Dec 2023 (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.
The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.
Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.
A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART@Home | Experimental | Behavioral: SMART@HomeUse of the SMART@Home app for medication and symptom tracking, spirometry feedback |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
- Ages 12-18
- English fluency for patient and caregiver
Key exclusion criteria (2 listed)
- Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
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 |
|---|---|---|
| SMART@HomeDaily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided. | Behavioural | SMART@Home |
Primary outcome
Medication Adherence
Time frame: 6 months
Monthly adherence will be calculated by comparing doses taken to doses recommended by IMAAP. Participants will also report rescue medication use each month when completing the ACT.
Number of days app used
Time frame: 6 months
Number of diaries completed by participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Asthma
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.
Kevin Hommel, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Rachelle Ramsey, PhD study chair
Children's Hospital Medical Center, Cincinnati
Matt Wortman, PhD study chair
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART@Home in people with Asthma and Asthma in Children, run by Children's Hospital Medical Center, Cincinnati 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 3 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Hommel, PhD (513-803-0407, kevin.hommel@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 6 months). The study lists 2 primary outcomes in all. 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 6 Oct 2026.