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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASTHMAXcel mobile application
Outpatient primary care
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring informatics, asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

English-speaking individuals >18 years with:

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

Exclusion Criteria:

  1. use of oral corticosteroids in the 2 weeks prior to the baseline visit
  2. pregnancy
  3. severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
  4. patients that previously received ASTHMAXcel

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASTHMAXcel arm

Usual care arm

Arm Description

The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma.

This arm represents usual care delivered in the outpatient primary care setting at the study sites.

Outcomes

Primary Outcome Measures

Change from baseline asthma quality of life to 2, 6, and 12 months
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

Secondary Outcome Measures

Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Change from baseline asthma knowledge to 2 months, 6 months, and 12 months
Asthma knowledge as measured by the validated KASE asthma questionnaire
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Change from baseline asthma control to 2, 6, and 12 months
Asthma symptom burden as measured by the Asthma Control Test
Depression as measured by the Patient Health Questionnaire-9
Depression as measured by the Patient Health Questionnaire-9
Number of asthma emergency department visits
Number of asthma emergency department visits
Number of asthma hospitalizations
Number of asthma hospitalizations

Full Information

First Posted
February 15, 2019
Last Updated
June 6, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03847142
Brief Title
An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
Official Title
Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
informatics, asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASTHMAXcel arm
Arm Type
Experimental
Arm Description
The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma.
Arm Title
Usual care arm
Arm Type
Active Comparator
Arm Description
This arm represents usual care delivered in the outpatient primary care setting at the study sites.
Intervention Type
Other
Intervention Name(s)
ASTHMAXcel mobile application
Intervention Description
ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.
Intervention Type
Other
Intervention Name(s)
Outpatient primary care
Intervention Description
Usual care delivered through the outpatient primary care setting
Primary Outcome Measure Information:
Title
Change from baseline asthma quality of life to 2, 6, and 12 months
Description
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
Time Frame
Baseline, 2 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Description
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Description
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Change from baseline asthma knowledge to 2 months, 6 months, and 12 months
Description
Asthma knowledge as measured by the validated KASE asthma questionnaire
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Description
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Change from baseline asthma control to 2, 6, and 12 months
Description
Asthma symptom burden as measured by the Asthma Control Test
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Depression as measured by the Patient Health Questionnaire-9
Description
Depression as measured by the Patient Health Questionnaire-9
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Number of asthma emergency department visits
Description
Number of asthma emergency department visits
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Number of asthma hospitalizations
Description
Number of asthma hospitalizations
Time Frame
Baseline, 2 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunit Jariwala
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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

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