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Remote Anxiety Management for ICS-resistant Asthma Study

Study acronym: RAMICS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion pushed from Jun 30, 2026 to Feb 28, 2027
    • Study completion pushed from Jun 30, 2026 to Jun 30, 2027
    v6
  2. Study sites: 4 to 11v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Jan 10, 2025 to Dec 13, 2024
    v3
  5. Secondary endpoints revised (14)v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06732141
Lead Sponsor First Affiliated Hospital of Ningbo University
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov