Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 11
- 主要终点
- ICS Adherence
研究概览
简要总结
This study, the Remote Anxiety Management for ICS-resistant Asthma Study (RAMICS), explores strategies to improve medication adherence and anxiety management in asthma patients who are resistant to using inhaled corticosteroids (ICS) due to anxiety. Asthma is a chronic respiratory disease affecting millions worldwide, and ICS therapy is essential for controlling symptoms and preventing severe exacerbations. However, many patients struggle with adherence, especially those with anxiety about ICS side effects. RAMICS is a multicenter, open-label, randomized controlled trial designed to evaluate the effectiveness of personalized telephone-based interventions, including medication education, progressive muscle relaxation (PMR), motivational interviewing (MI), and lung rehabilitation guidance. The study will enroll 216 adult asthma patients with poor ICS adherence and clinically significant anxiety. Participants will be randomized into two groups: the intervention group, receiving weekly telephone sessions, and the control group, receiving standard follow-up calls. The study aims to assess improvements in ICS adherence, reductions in anxiety and depression, better asthma symptom control, and enhanced quality of life. Outcomes will be evaluated immediately after the 8-week intervention and during a 3-month follow-up. By addressing both psychological and medication adherence challenges, this research aims to provide practical solutions for improving asthma management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age Requirement:
- •Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to interventions.
- •Diagnosed Asthma:
- •Diagnosis must meet the criteria of the Global Initiative for Asthma (GINA) or the American Academy of Asthma guidelines, with at least one confirmed diagnosis by a specialist in the past six months.
- •Asthma severity must range from mild to moderate persistent, in the chronic management phase, excluding patients in acute exacerbation phases for clearer evaluation of adherence and intervention effects.
- •ICS Treatment History:
- •Participants must have been on inhaled corticosteroid (ICS) therapy for at least six months, ensuring sufficient treatment history for adherence and effect evaluation.
- •No major changes to asthma control medication regimen in the past six months, ensuring adherence and intervention outcomes are not confounded by treatment changes.
- •Poor Medication Adherence:
- •Identified using the Medication Adherence Report Scale (MARS-10), with an average score <4.5, indicating suboptimal adherence.
- •Presence of Anxiety Symptoms:
- •Confirmed through the Hamilton Anxiety Rating Scale (HAMA), with a score ≥14, indicating clinically significant anxiety.
- •Anxiety symptoms must be related to asthma treatment, particularly concerns about ICS side effects or long-term use, ensuring the psychological intervention targets relevant issues.
- •Ability to Communicate by Phone:
- •Participants must have stable access to a phone and be willing to engage in telephone-based psychological interventions.
- •Stable Health Condition:
- •Asthma status must be stable, with no acute exacerbations or significant changes in the past month.
排除标准
- •Severe Psychiatric or Cognitive Disorders:
- •Diagnosis of major psychiatric disorders, such as major depressive disorder, bipolar disorder, schizophrenia, or other severe mental illnesses within the past six months, based on DSM-5 criteria.
- •Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or adherence to the intervention.
- •Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.
- •Substance Abuse or Dependence:
- •History of alcohol or drug abuse within the past six months, including but not limited to opioids, benzodiazepines, or illicit substances.
- •Severe Comorbidities:
- •Uncontrolled respiratory or cardiovascular conditions, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, heart failure, or uncontrolled hypertension, that could significantly impact asthma control and overall health.
- •Chronic diseases requiring long-term systemic corticosteroid therapy, such as rheumatic or autoimmune diseases, that may interfere with ICS treatment and study outcomes.
- •Pregnancy or Lactation:
- •Pregnant or breastfeeding women are excluded due to the unclear risks of ICS treatment and anxiety management interventions in these populations.
- •Allergic Bronchopulmonary Aspergillosis (ABPA) or Related Conditions:
- •Diagnosed ABPA or other respiratory diseases with mechanisms distinct from asthma, which could confound the assessment of ICS treatment effects.
- •Participation in Other Interventional Clinical Trials:
- •Participation in another interventional clinical trial within the past three months, particularly those involving respiratory diseases or medication adherence management, to avoid confounding effects on outcomes.
- •Incompatibility with Telephone-Based Interventions:
- •Inability to reliably receive or engage in telephone-based psychological interventions due to hearing impairments, communication barriers, or other reasons.
- •Adverse Reactions to Psychological Interventions:
- •Documented refusal of or adverse reactions to psychological interventions, such as phone-based relaxation or motivational interviewing, that could affect the feasibility and effectiveness of the study.
- •History of Major Surgery or Hospitalization:
- •History of major surgery or hospitalization (unrelated to asthma) within the past six months that might impact current health status and introduce bias into the study outcomes.
研究组 & 干预措施
Personalized telephone-based psychological support
Participants in this group will receive weekly, personalized 30-minute telephone sessions for 8 weeks, including medication education, lung rehabilitation guidance, motivational interviewing (MI), and progressive muscle relaxation (PMR).
干预措施: Personalized Telephone-Based Psychological Support (Behavioral)
Standard Care with Weekly Follow-Up Calls
Participants in this group will receive weekly standard care calls for 8 weeks, focusing on health status, asthma symptoms, and medication use, without psychological or educational interventions.
干预措施: Standard Care with Weekly Follow-Up Calls (Behavioral)
结局指标
主要结局
ICS Adherence
时间窗: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
Medication adherence will be assessed using the Medication Adherence Report Scale (MARS-10), a validated questionnaire. The scale includes 10 items, each scored from 1 (always) to 5 (never), with total scores ranging from 10 to 50. Higher scores indicate better adherence, and a mean score of ≥4.5 reflects good adherence.
次要结局
- Anxiety Levels(Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Depression Levels(Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Asthma Control Levels(Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Asthma-Related Quality of Life(Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Incidence of Serious Adverse Events (SAEs)(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, and 3-month follow-up.)
- Intervention Adherence(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8.)
- Asthma Exacerbation Events(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Frequency of Emergency Department Visits(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Frequency of Hospitalizations(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Occurrence of Respiratory Failure(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Use of Non-Invasive Ventilation(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- ICU Admission and Intubation(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Systemic Steroid Use(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
- Length of Hospital Stay(Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.)
研究者
Chao Cao, Ph.D.
Principal Investigator
First Affiliated Hospital of Ningbo University