Remote Anxiety Management for ICS-resistant Asthma Study
RAMICS
Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled Trial
1 other identifier
interventional
216
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Dec 2024
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 13, 2024
CompletedStudy Start
First participant enrolled
December 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
March 31, 2026
March 1, 2026
1.5 years
December 9, 2024
March 30, 2026
Conditions
Outcome Measures
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.
Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
Secondary Outcomes (14)
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.
- +9 more secondary outcomes
Study Arms (2)
Personalized telephone-based psychological support
EXPERIMENTALParticipants 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).
Standard Care with Weekly Follow-Up Calls
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- +2 more criteria
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Second Affiliated Hospital of Harbin Medical University
Harbin, China
Anhui Chest Hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Jingzhou Central Hospital
Jingzhou, China
Haishu District People's Hospital
Ningbo, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Qianhu Hospital
Ningbo, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Ninghai County First Hospital
Ninghai, China
Taizhou Central Hospital
Taizhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 9, 2024
First Posted
December 13, 2024
Study Start
December 13, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share