AsthmaCAMPPNCT02747706
Childhood Asthma Mentoring Program for Parents
A study testing Parent-to-parent mentoring in people with Asthma, run by InquisitHealth, Inc. at 1 site in United States.
Trial summary
There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Parent-to-parent mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Mar 2018
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent of child with persistent asthma, prescription of controller medications, and at least one asthma exacerbation in the past year
Who cannot join
- Parent has no access to smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
InquisitHealth
River Edge, New Jersey, 07661
Ashwin Patel, MD PhD, 855-412-1787, ashwin@inquisithealth.com
About this study
Official title: Peer Mentor Training to Reduce Hospitalizations for Children With Asthma
There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the community) can be effective in reducing hospitalizations for asthmatic children.
This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to reduce asthma-related pediatric hospitalizations and emergency department visits.
- Conditions
- Asthma
- Being tested
- Parent-to-parent mentoring
- Keywords
- peer mentor, health coach, parent support, parent mentor
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-to-parent mentoringBehavioural
phone, SMS/text, and smartphone-based support
| Study group | Role | What they receive |
|---|---|---|
| Parent Mentoring | Experimental | 1-on-1, phone, SMS/text, and smartphone-based parent-to-parent mentoring. Receives: Behavioral: Parent-to-parent mentoring |
| Usual Care | No intervention | No intervention through study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital admissions
Measured: 1-year
Number of emergency department visits
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017 (estimated)
- Study completionMar 2018 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InquisitHealth, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Montefiore Medical Center, University of North Carolina, Chapel Hill, Washington University School of Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ashwin Patel, InquisitHealth, Inc.
- Investigators
- Ashwin Patel, MD PhD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747706
- Sponsor's protocol ID
- Asthma23
- Other IDs
- 4R44HD081830
- Acronym
- CAMPP
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Mentor Training to Reduce Hospitalizations for Children With Asthma
- ClinicalTrials.gov ID
- NCT02747706
- Acronym / sponsor ID
- CAMPP / Asthma23
- Conditions
- Asthma
- Keywords
- peer mentor, health coach, parent support, parent mentor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- InquisitHealth, Inc.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Montefiore Medical Center, University of North Carolina, Chapel Hill, Washington University School of Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 22 Apr 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.
There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the community) can be effective in reducing hospitalizations for asthmatic children.
This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to reduce asthma-related pediatric hospitalizations and emergency department visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Mentoring | Experimental | Behavioral: Parent-to-parent mentoring1-on-1, phone, SMS/text, and smartphone-based parent-to-parent mentoring. |
| Usual Care | No intervention | –No intervention through study. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parent of child with persistent asthma, prescription of controller medications, and at least one asthma exacerbation in the past year
Key exclusion criteria (1 listed)
- Parent has no access to smartphone
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 |
|---|---|---|
| Parent-to-parent mentoringphone, SMS/text, and smartphone-based support | Behavioural | Parent Mentoring |
Primary outcome
Number of hospital admissions
Time frame: 1-year
Number of emergency department visits
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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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.
Ashwin Patel, MD PhD principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-to-parent mentoring in people with Asthma, run by InquisitHealth, Inc. 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashwin Patel, MD PhD (855-412-1787, ashwin@inquisithealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital admissions (time frame: 1-year). 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 22 Apr 2016.