Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 389
- 试验地点
- 2
- 主要终点
- Electronically Monitored Controller Medication Adherence
研究概览
简要总结
The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.
详细描述
Our goal is to evaluate our promising mHealth intervention (Asthma Ctrl) that is easily accessible and tailored based on adherence barriers and to examine predictors of treatment response. In this multi-site R01 with Children's Hospital Colorado, the study investigators will conduct a 2-stage sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of our mHealth intervention strategies for improving adherence to daily inhaled corticosteroids in adolescents with asthma. Following a baseline period, adolescents will be randomized to a mHealth asthma management app (control group) or Asthma Ctrl, a text-messaging intervention providing adherence feedback based on adherence monitoring (treatment) for SMART Stage 1. Participants will be excluded from the study if they have an adherence that is >68%. For SMART Stage 2, adolescents randomized to the treatment group who demonstrate non-adherence (≤68% adherence; non-response) will undergo a second randomization to receive either 1) continued Asthma Ctrl (text messaging) or 2) Asthma Ctrl+ (Asthma Ctrl augmented with a problem-solving intervention delivered via telehealth). Thus, there are three intervention strategies that will be tested in this SMART: #1 control condition, #2 treatment, and #3 adapted treatment after Stage 2 and at follow-up (1 and 6 months). This innovative SMART design will address objectives described in the brief summary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between 12-18 years
- •Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- •Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- •English fluency for patient, caregiver, and clinician
排除标准
- •Significant cognitive deficits that may interfere with comprehension per medical team or chart review
- •Diagnosis of serious mental illness (e.g., schizophrenia)
- •Diagnosis of pervasive developmental disorder
- •Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia)
- •Patient receives school administered daily controller medication at the time of the enrollment visit
研究组 & 干预措施
Asthma Ctrl+
Participants will receive the Asthma Ctrl+ intervention
干预措施: Asthma Ctrl+ (Behavioral)
Control
Participants will receive access to an asthma management application providing education and automated reminders
干预措施: Control (Behavioral)
Asthma Ctrl
Participants will receive the Asthma Ctrl intervention
干预措施: Asthma Ctrl (Behavioral)
结局指标
主要结局
Electronically Monitored Controller Medication Adherence
时间窗: 12 months
Monthly adherence rates will be calculated by dividing the number of doses recorded by the electronic monitor by the total number of prescribed doses; the rate is then multiplied by 100 to determine the percentage. For patients prescribed Single Maintenance and Reliever Therapy, per the new asthma guidelines, the study investigators will assume that initial doses taken are for prevention and adherence will be capped at 100%.
次要结局
- Composite Asthma Severity Index (CASI)(Baseline assessment and then once a month for 12 months)
- Asthma Control: Asthma Control Test (ACT)(Baseline assessment and then once a month for 12 months)
- Lung Function(Baseline and then once a month for 12 months)
- Lung Function(Baseline and then once a month for 12 months.)
- Healthcare Utilization(Baseline assessment and then once a month for 12 months.)
- Asthma Exacerbations(Baseline assessment and then once a month for 12 months.)