Adapting and Expanding the Asthma-Educator App

NCT03930381 | Completed

• 1 other identifier: 2018-9083
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Asthma Control to 3 Month Asthma Control

  Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)

  Post-Refinement Baseline, 3 Months

• Change from Baseline Asthma Control to 3 Month Asthma Control

  Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)

  Post-Refinement Baseline, 4 Months

Secondary Outcomes (9)

• Asthma Symptom Perception

  Week 2, Week 4 , Week 6 (Pre and Post Refinement)

• Asthma Knowledge

  Post-Refinement Baseline, 3 Month

• Medication Adherence

  Post-Refinement Baseline, 3 Month

• Asthma Quality of Life

  Post-Refinement Baseline, 3 Month

• Emergency Department Visits

  Post-Refinement Baseline, 3 Month

Study Arms (2)

Intervention Arm

EXPERIMENTAL

This group will download the ASTHMAXcel application and use it for the duration of the study

Other: ASTHMAXcel App

Usual Care Arm

NO INTERVENTION

This group will just receive normal provider care

Interventions

ASTHMAXcel App OTHER

ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.

Intervention Arm

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English-speaking individuals between 15-21
• Persistent asthma (diagnosis made by a healthcare provider)
• On a daily controller medication
• Able to give informed consent
• Smartphone (iOS or Android) access

You may not qualify if:

• Use of oral corticosteroids in the 2 weeks prior to the baseline visit
• Pregnancy
• Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
• Patients that previously received the ASTHMA-Educator application

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

  PMID: 35691614 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sunit Jariwala, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 29, 2019
• Study Start: May 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)