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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Personalized Telephone-Based Psychological Support
BehavioralThis 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.
Standard Care with Weekly Follow-Up Calls
BehavioralParticipants 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.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: Personalized telephone-based psychological supportExperimental treatment 1 intervention
Group B: Standard Care with Weekly Follow-Up CallsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
ICS Adherence
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.
Time frame
Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.Secondary outcomes
1
Anxiety Levels
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a validated scale with scores ranging from 0 to 56, where higher scores indicate greater anxiety severity. The intervention aims to reduce anxiety related to ICS use through techniques such as progressive muscle relaxation (PMR) and motivational interviewing (MI).
Time frame
Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.2
Depression Levels
Depressive symptoms will be observed using the Hamilton Depression Rating Scale (HAMD), which scores from 0 to 52, with higher scores indicating more severe depression. While the intervention may indirectly impact depressive symptoms, its specific effect on depression is not a primary focus and will require further investigation.
Time frame
Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.3
Asthma Control Levels
Asthma symptom control will be assessed using the Asthma Control Test (ACT), a validated questionnaire with scores ranging from 5 to 25. Higher scores indicate better asthma control. The intervention aims to improve asthma control by enhancing ICS adherence and addressing anxiety-related barriers.
Time frame
Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.4
Asthma-Related Quality of Life
Health-related quality of life will be evaluated using the Asthma Quality of Life Questionnaire (AQLQ), which measures the impact of asthma on daily activities, social interactions, and overall health perception. The scores range from 1 to 7, with higher scores indicating a better quality of life. The intervention aims to enhance patients' ability to manage asthma and reduce its negative impact on their quality of life.
Time frame
Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov