Improving Medication Adherence With Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 21
- 主要终点
- Proportion of adherent days as assessed by Propeller sensors
研究概览
简要总结
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) is a multi-center, randomized parallel group study targeted to an at-risk population of Adolescents and Young Adults (AYA) with uncontrolled asthma who have poor adherence with prescribed Inhaled corticosteroid (ICS) therapy.
详细描述
The study evaluates a Medication Therapy Management (MTM) video telehealthcare intervention to address poor medication adherence. In addition, it employs a novel method to track and provide feedback to participants on adherence by using Propeller Sensors. 300 adolescents and young adults will be randomized to Medication Therapy Management (MTM) video telehealthcare plus electronic adherence self-management [MTM EAM] or electronic adherence self-management alone (EAM) (also known as Digital Adherence Monitoring [DAM]). Due to the hierarchal design of the trial, two primary outcomes to be tested in a sequential manner are specified, adherence and time to first asthma exacerbation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 through 35 years
- •Speaks English or Spanish
- •Physician diagnosed asthma (without any other co-morbid pulmonary disease)
- •Prescribed ICS treatment for at least 3 months prior to screening
- •Adherence to Refills and Medication Scale (ARMS) 7-item questionnaire score of >8 (low or moderate adherence)
- •Current use of albuterol metered dose inhaler (MDI) for rescue: ProAir, Ventolin, albuterol sulfate (from Prasco or Teva)
- •Uncontrolled asthma:
- •Symptomatic asthma defined as 3 of the following in the past 4 weeks:
- •Daytime symptoms of asthma more than twice per week
- •Any night awakening due to asthma
- •Rescue inhaler use for symptoms more than twice per week
- •Any activity limitation due to asthma; OR
- •Asthma Control Test score ≤19
- •Has iPhone or Android smart phone with Short Message Service (SMS)
- •Has access to reliable WiFi service and a device with capability for telemedicine study visits
- •Ability to understand and willingness to sign consent documents
- •Evidence of Propeller sensor connection in the 4-week run-in period
排除标准
- •Use of an investigational treatment in the previous 30 days.
- •Previous enrollment in MATCH Structured Interviews ( Aim 1)
- •Currently enrolled in an intervention trial
- •Currently uses an ICS not compatible with the Propeller sensor
- •Inability to comply with study procedures, including:
- •Inability or unwillingness to provide informed consent (or assent in the case of a minor).
- •Inability to perform study measurements.
- •inability to be contacted by phone via calls and /or text messaging
- •Not willing to have video chat
- •Any condition(s) in the opinion of the physician that puts the participant at risk from participating in the study
研究组 & 干预措施
MTM-EAM
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM]
干预措施: Medication Therapy Management (MTM) Video Telehealthcare (Behavioral)
MTM-EAM
Medication Therapy Management Video Telehealthcare plus Electronic Adherence Self-Management [MTM-EAM]
干预措施: Electronic Adherence Self-Management (EAM) (Behavioral)
EAM only
Electronic Adherence Self-Management [EAM] only
干预措施: Electronic Adherence Self-Management (EAM) (Behavioral)
结局指标
主要结局
Proportion of adherent days as assessed by Propeller sensors
时间窗: 12 months
Adherence will be measured using data collected from Propeller sensors. Adherence for each day is calculated as the number of inhalations taken divided by the expected number of doses. A day will be defined as adherent if the participant completes 80% or more of the prescribed inhalations. The primary outcome will be the proportion of adherent days over the course of follow-up, i.e. from the randomization visit to the 1-year visit.
Time (days) to first exacerbation event
时间窗: 12 months
Time to first asthma exacerbation is the time to first exacerbation event defined as a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, or asthma-specific emergency department visit with treatment with systemic corticosteroids, or asthma-specific hospitalization, or death (all cause and asthma exacerbation). 104. These data will be collected by self-report in the "My Asthma" bi-weekly assessment questionnaire, and verified by the study site coordinator with the participant's provider.
Proportion of ICS Inhaler Adherent Days
时间窗: Up to 12 months
Proportion of daily adherence over the follow-up period recorded using the digital sensor on the ICS inhaler (adherence outcome) Daily ICS adherence was calculated as a proportion of sensor-recorded inhalations to the number expected based on prescribed daily dose. For primary analyses, an adherent day was defined as completion of at least 75% of prescribed inhalations, with adherence capped at 100%. The time frame of 12 months includes a run-in period prior to randomization.
Percent Cumulative Incidence Severe Exacerbation
时间窗: Up to 12 months
Percent cumulative incidence of first asthma severe exacerbation (efficacy outcome). Percent cumulative incidence of first severe asthma exacerbation was defined as a worsening of asthma requiring: (1) use of systemic corticosteroids for at least three days, (2) an emergency department visit requiring systemic corticosteroid treatment, (3) hospitalization due to asthma, or (4) death from any cause. Exacerbations were identified using biweekly My Asthma surveys, in which participants reported health-care use, medication changes, and impacts on work or school.
次要结局
未报告次要终点