Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients (PEAKmAAP)
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|ClinicalTrials.gov Identifier: NCT03842033|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Asthma||Behavioral: PEAKmAAP Behavioral: PEAKmAAP-DS Behavioral: NutriMap Usual Care||Not Applicable|
The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH).
We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||372 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We will conduct a randomized, controlled trial of 372 adolescents with uncontrolled mild-severe persistent asthma to examine the effectiveness of a personalized, interactive PEAKmAAP application with and without PCP data sharing in reducing asthma morbidity. The trial includes 3 groups: 1) a group utilizing the PEAKmAAP alone, 2) a group utilizing the PEAKmAAP with PCP data sharing (PEAKmAAP-DS), and 3) a usual care NutriMapgroup utilizing an application with daily non-asthma related reminders for attention control.|
|Masking:||None (Open Label)|
|Official Title:||Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients|
|Estimated Study Start Date :||February 15, 2019|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||December 31, 2022|
The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification.
The PEAKmAAP group will use a mobile "app" that will help manage asthma.
PEAKmAAP-Data Sharing (DS)
PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time.
This group will use the mobile app to help manage asthma. the primary care provider will receive monthly reports to help him/her know how the participants asthma symptoms are over time.
Nutrition Map (NutriMap) Usual Care
Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management.
Behavioral: NutriMap Usual Care
This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.
- Change in Asthma Control Test (ACT) Score [ Time Frame: 12 months ]ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including (ACT) score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function.
- Composite Asthma Severity Index (CASI) score [ Time Frame: 12 months ]The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations.
- Healthcare Utilization [ Time Frame: 3 months ]We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning.
- Mediators of Asthma Control [ Time Frame: 12 months ]Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL) to determine asthma self-efficacy. We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines.
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): NCT03842033
|Contact: Rita C. Hudson Brown, BA||501-364-1538 ext firstname.lastname@example.org|
|Contact: Jessica H. Turner, BS||501-364-3638 ext email@example.com|
|United States, Arkansas|
|Arkansas Children's Hospital Research Institute||Not yet recruiting|
|Little Rock, Arkansas, United States, 72202|
|Contact: Rita C Hudson Brown, BA 501-364-1538 ext 41538 firstname.lastname@example.org|
|Contact: Jessica H Turner, BS 501-364-3638 ext 43638 email@example.com|
|Principal Investigator: Tamara T. Perry, M.D.|
|Principal Investigator:||Tamara T. Perry, MD||University of Arkansas|