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

NCT ID: NCT03847142

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ASTHMAXcel arm

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

Group Type EXPERIMENTAL

ASTHMAXcel mobile application

Intervention Type OTHER

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

Usual care arm

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

Group Type ACTIVE_COMPARATOR

Outpatient primary care

Intervention Type OTHER

Usual care delivered through the outpatient primary care setting

Interventions

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ASTHMAXcel mobile application

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

Intervention Type OTHER

Outpatient primary care

Usual care delivered through the outpatient primary care setting

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sunit Jariwala

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36799736 (View on PubMed)

Other Identifiers

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R18HS025645

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2018-9027

Identifier Type: -

Identifier Source: org_study_id

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