Asthma Ctrl SMART Trial

Официальное название

Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Asthma Ctrl
  Individualized adherence feedback via text messaging intervention based on real-time adherence monitoring
• Поведенческое Asthma Ctrl+
  Interventions described in Asthma Ctrl with problem-solving skills training via four telehealth sessions to occur every other week.
• Поведенческое Control
  Asthma management application providing education and automated reminders

Первичные конечные точки

• Electronically Monitored Controller Medication Adherence [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Composite Asthma Severity Index (CASI) [Срок оценки: Baseline assessment and then once a month for 12 months]
• Asthma Control: Asthma Control Test (ACT) [Срок оценки: Baseline assessment and then once a month for 12 months]
• Lung Function [Срок оценки: Baseline and then once a month for 12 months]
• Lung Function [Срок оценки: Baseline and then once a month for 12 months.]
• Lung Function [Срок оценки: Baseline and then once a month for 12 months]
• Lung Function [Срок оценки: Baseline and then once a month for 12 months]
• Healthcare Utilization [Срок оценки: Baseline assessment and then once a month for 12 months.]
• Asthma Exacerbations [Срок оценки: Baseline assessment and then once a month for 12 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Colorado AMC — Aurora
• Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT07512622 · 2024-0434 · 1R01HL172827-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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