A Randomized Controlled Trial of AppS to Home Monitor Your Asthma (ASTHMA)
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|ClinicalTrials.gov Identifier: NCT04401332|
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: mobile health app||Not Applicable|
The specific aims of this study are:
- Adapt our existing health IT-enabled practice model for asthma symptom monitoring using PROs to a primary care population. The health IT-enabled practice model is comprised of the following: an mHealth app that can be installed on patients' smartphones that integrates into clinical workflow; and an asthma PRO dashboard in the electronic health record (EHR) for clinicians.
- Implement the adapted health IT-enabled practice model in 4 primary care community clinics, identify a cohort of eligible asthma patients to participate, and train clinicians and clinical staff.
- Rigorously evaluate the impact of this new health IT-enabled practice model using a randomized controlled trial study in which we enroll 500 asthma patients (250 intervention, 250 usual care) by primary care clinician. We will measure patient-reported asthma quality of life and asthma-related healthcare utilization (defined as urgent care and emergency room visits and hospitalizations) as our primary and secondary outcomes, respectively. We will use mixed methods to identify barriers and facilitators to implementation and factors that affect sustainable spread and scale as per the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits|
|Actual Study Start Date :||July 21, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Other: mobile health app
asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones
|No Intervention: Usual Care|
- Asthma-related patient-reported quality of life [ Time Frame: 6 months from enrollment ]Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
- Asthma-related patient-reported quality of life [ Time Frame: 12 months from enrollment ]Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
- Asthma-related healthcare utilization [ Time Frame: 12 months from enrollment ]Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401332
|Contact: Robert S Rudin, PhD||(617) 338-2059 ext firstname.lastname@example.org|
|Contact: Jessica L Sousa, MSW, MPH||(617) 338-2059 ext email@example.com|