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Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma

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ClinicalTrials.gov Identifier: NCT03036982
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew MacGinnitie, Boston Children’s Hospital

Brief Summary:
This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma Control Test (cACT) for mobile devices improves rate of completion and improves control of asthma in children and adolescents

Condition or disease
Asthma

Detailed Description:

Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%. While effective therapies exist to control symptoms and prevent exacerbations, many asthma patients experience significant morbidity including limitations on daily activities as well as asthma exacerbations that lead to missed school (and work for care givers) and necessitate emergency department visits and hospitalizations. Among children from lower socioeconomic statues and in black and Hispanic families, asthma incidence and severity are even greater. Reasons for this disparity included decreased access to effective asthma care, increased exposure to tobacco smoke and environmental allergens, and underutilization of controller medicines. These groups have significantly increased resource utilization due to emergency department visits and hospitalizations. Optimal care for asthma patients, especially those with at highest risk, will therefore require new strategies for evaluating ongoing control and providing direct feedback to patients.

We propose to transform the way asthma care is provided through the use of an innovative patient centered technology -Trivox Asthma ‐ to improve quality of care and outcomes for asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to facilitate closer monitoring of patients with asthma through the existing web platform and a new mobile interface. This will allow asthma patients, their parents and school nurses to remotely input data on asthma control through smartphones and/or tablets. We will use the ACT+, an expansion of a validated measure currently utilized in both primary care and specialty clinics, to measure both asthma control and risk.

Effectiveness of this intervention will be measured by examining resource utilization and ongoing asthma control.


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Study Type : Observational
Actual Enrollment : 221 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Use of Mobile ACT
Will answer ACT (or cACT) and other asthma questions using mobile app



Primary Outcome Measures :
  1. Well-controlled asthma [ Time Frame: Each month for one calendar year ]
    Percent of ACT scores with value of 20 or greater


Secondary Outcome Measures :
  1. Asthma Emergency Department visits and hospitalizations [ Time Frame: Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year ]
    Asked every 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with asthma seen in one of the clinics caring for patients with asthma at Boston Children's Hospital Age 4-21
Criteria

Inclusion Criteria:

  • Diagnosis of asthma
  • Cared for at Boston Children's Hospital (Primary or secondary care)

Exclusion Criteria:

  • Age <4 or >21

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036982


Locations
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United States, Massachusetts
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Andrew MacGinnitie, MD PhD Boston Children's Hosptial

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Responsible Party: Andrew MacGinnitie, Associate Clinical Director, Division of Immunology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03036982     History of Changes
Other Study ID Numbers: FP01013808
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will make deidentified data available for other researchers

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases