Skip to main content
OpenTrials
Completed

NCT Number: NCT03847142

An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care

Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

English-speaking individuals >18 years with:

  • persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
  • able to give informed consent
  • Smartphone (iOS or Android) access

Exclusion criteria

  • 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 completing the protocol
  • patients that previously received ASTHMAXcel

Treatment and study plan

ASTHMAXcel mobile application

Other

ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.

Outpatient primary care

Other

Usual care delivered through the outpatient primary care setting

Primary outcomes

  1. Change from baseline asthma quality of life to 2, 6, and 12 months

    Time frame: Baseline, 2 months, 6 months, 12 months

    Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

Secondary outcomes

  1. Patient satisfaction measured by the Client Satisfaction Questionnaire-8

    Time frame: Baseline, 2 months, 6 months, 12 months

    Patient satisfaction measured by the Client Satisfaction Questionnaire-8

  2. Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire

    Time frame: Baseline, 2 months, 6 months, 12 months

    Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire

  3. Change from baseline asthma knowledge to 2 months, 6 months, and 12 months

    Time frame: Baseline, 2 months, 6 months, 12 months

    Asthma knowledge as measured by the validated KASE asthma questionnaire

  4. Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire

    Time frame: Baseline, 2 months, 6 months, 12 months

    Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire

  5. Change from baseline asthma control to 2, 6, and 12 months

    Time frame: Baseline, 2 months, 6 months, 12 months

    Asthma symptom burden as measured by the Asthma Control Test

  6. Depression as measured by the Patient Health Questionnaire-9

    Time frame: Baseline, 2 months, 6 months, 12 months

    Depression as measured by the Patient Health Questionnaire-9

  7. Number of asthma emergency department visits

    Time frame: Baseline, 2 months, 6 months, 12 months

    Number of asthma emergency department visits

  8. Number of asthma hospitalizations

    Time frame: Baseline, 2 months, 6 months, 12 months

    Number of asthma hospitalizations

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2019
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.