Remote Anxiety Management for ICS-resistant Asthma Study
ConditionAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Ningbo University
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- Personalized Telephone-Based Psychological Support
- Standard Care with Weekly Follow-Up Calls
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov