NCT02747706

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

April 18, 2016

Last Update Submit

April 19, 2016

Conditions

Keywords

peer mentorhealth coachparent supportparent mentor

Outcome Measures

Primary Outcomes (2)

  • Number of hospital admissions

    1-year

  • Number of emergency department visits

    1-year

Study Arms (2)

Parent Mentoring

EXPERIMENTAL

1-on-1, phone, SMS/text, and smartphone-based parent-to-parent mentoring.

Behavioral: Parent-to-parent mentoring

Usual Care

NO INTERVENTION

No intervention through study.

Interventions

phone, SMS/text, and smartphone-based support

Parent Mentoring

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent of child with persistent asthma, prescription of controller medications, and at least one asthma exacerbation in the past year

You may not qualify if:

  • Parent has no access to smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InquisitHealth

River Edge, New Jersey, 07661, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ashwin Patel, MD PhD

    Chief Medical Officer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashwin Patel, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 22, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations