NCT02205723

Brief Summary

The objective of this protocol is to pilot an innovative approach to medication adherence to determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence, a critical gap in improving the health of children with asthma. SNAPP incorporates monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS medication adherence and that the investigators believe will influence the child's future independence and chronic disease-management skills.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
7.3 years until next milestone

Study Start

First participant enrolled

December 3, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

July 28, 2014

Last Update Submit

November 11, 2020

Conditions

Keywords

AsthmaAsthma exacerbationsPediatric

Outcome Measures

Primary Outcomes (1)

  • Childhood asthma control test

    Measurement of change of C-ACT at 6 months.

    6 months

Secondary Outcomes (1)

  • Fractional excretion of exhaled nitric oxide

    6 months

Study Arms (2)

Smartphone Asthma Control

EXPERIMENTAL

Smartphone Asthma Control

Behavioral: Asthma teaching in ERBehavioral: Smartphone Asthma Control

Control

ACTIVE COMPARATOR

Control group

Behavioral: Asthma teaching in ER

Interventions

Asthma teaching

Also known as: Asthma teaching
ControlSmartphone Asthma Control

Smartphone Asthma Control

Also known as: SNAPP
Smartphone Asthma Control

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • TennCare Medicaid insurance, and an acute exacerbation (45% of our ED patients with acute asthma, section C.11.)
  • Parent has a smartphone and wireless account that they agree to use for this study (if randomized to intervention group), anticipated residence in the Nashville Metropolitan Service Area for at least 12 months, willingness to participate in phone-based (wireless or landline) ACT-scoring monthly, and willingness to return at 3, 6 and 12 months for FeNO testing.
  • The participant's PCP agrees that patient has moderate or severe persistent asthma and should be on ICS for at least the subsequent 12 months in accordance with NIH-NAEPP expert panel guidelines.87,88

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Donald H Arnold, MD, MPH

    Vanderbilt University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 31, 2014

Study Start

December 3, 2021

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations