NCT06732141

Remote Anxiety Management for ICS-resistant Asthma Study

Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: First Affiliated Hospital of Ningbo University · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Telephone-Based Psychological Support	This intervention involves weekly, individualized 30-minute telephone sessions conducted over 8 weeks. The sessions are designed to address anxiety and improve adherence to inhaled corticosteroid (ICS) therapy in asthma patients. The intervention comprises four core components: 1. Medication Education: Detailed guidance on the benefits, mechanisms, and safety of ICS therapy, aiming to address misconceptions and reduce fears about side effects. 2. Lung Rehabilitation Guidance: Instructions for breathing exercises and tailored physical activity to improve respiratory health and overall well-being. 3. Motivational Interviewing (MI): A patient-centered approach that identifies barriers to adherence, enhances self-efficacy, and motivates behavior change. 4. Progressive Muscle Relaxation (PMR): A systematic relaxation technique to alleviate physical and emotional stress, tailored to each patient's anxiety levels.
BEHAVIORAL	Standard Care with Weekly Follow-Up Calls	Participants receive weekly telephone follow-up calls for 8 weeks. These calls include health status assessments, symptom monitoring, and general medication inquiries but exclude psychological or educational components.

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-12-13
• Last updated: 2026-03-31

Locations

11 sites across 1 country: China