NCT02435394

Brief Summary

Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.

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 Jul 2015

Shorter than P25 for not_applicable asthma

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withdrawn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

April 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

April 28, 2015

Last Update Submit

April 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • NHLBI recommended controller meds used

    match between severity rating and NHLBI recommended med mgt

    3-12 months

Secondary Outcomes (6)

  • Emergency department visits

    3-12 months

  • Asthma trigger mitigation

    3-12 months

  • Hospitalizations for asthma

    3-12 months

  • Steroid bursts

    3-12 months

  • Influenza vaccine receipt

    3-12 months

  • +1 more secondary outcomes

Study Arms (3)

Remote Coach plus Asthma Module

EXPERIMENTAL

The intervention is for practices to have remote coach support for patients with asthma in addition to doctors using CHADIS-Asthma module. Practices will start sequentially for a time series analysis.

Behavioral: Remote Coach plus Asthma Module

Asthma Module- No Coach

EXPERIMENTAL

The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence.

Behavioral: Asthma Module- No Coach

CHADIS- no Asthma module

ACTIVE COMPARATOR

Practices using CHADIS but no Asthma module as a control condition.

Behavioral: CHADIS- no Asthma Module

Interventions

The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.

Also known as: Remote Coach
Remote Coach plus Asthma Module

The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.

Asthma Module- No Coach

The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.

CHADIS- no Asthma module

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Asthma diagnosis

You may not qualify if:

  • Not English or Spanish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Total Child Health

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Barbara J Howard, MD

    Total Child Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 6, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations