NCT03847142

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

3.2 years

First QC Date

February 15, 2019

Last Update Submit

June 6, 2023

Conditions

Asthma

Keywords

informaticsasthma

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline, 2 months, 6 months, 12 months

Secondary Outcomes (8)

  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8

    Baseline, 2 months, 6 months, 12 months

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

    Baseline, 2 months, 6 months, 12 months

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

    Baseline, 2 months, 6 months, 12 months

  • Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire

    Baseline, 2 months, 6 months, 12 months

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

    Baseline, 2 months, 6 months, 12 months

  • +3 more secondary outcomes

Study Arms (2)

ASTHMAXcel arm

EXPERIMENTAL

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

Other: ASTHMAXcel mobile application

Usual care arm

ACTIVE COMPARATOR

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

Other: Outpatient primary care

Interventions

ASTHMAXcel mobile applicationOTHER

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

ASTHMAXcel arm
Outpatient primary careOTHER

Usual care delivered through the outpatient primary care setting

Usual care arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 completing the protocol
  • patients that previously received ASTHMAXcel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Silverstein GD, Styke SC, Kaur S, Singh A, Green S, Jariwala SP, Feldman J. The Relationship Between Depressive Symptoms, eHealth Literacy, and Asthma Outcomes in the Context of a Mobile Health Intervention. Psychosom Med. 2023 Sep 1;85(7):605-611. doi: 10.1097/PSY.0000000000001170. Epub 2023 Jan 27.

    PMID: 36799736DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sunit Jariwala

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 20, 2019

Study Start

March 1, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

US(1)