Clinical trial NCT06732141: Remote Anxiety Management for ICS-resistant Asthma Study
Official title: Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
First posted: 2024-12-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age Requirement:

   Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to interventions.
2. Diagnosed Asthma:

   1. 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.
   2. 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.
3. ICS Treatment History:

   1. Participants must have been on inhaled corticosteroid (ICS) therapy for at least six months, ensuring sufficient treatment history for adherence and effect evaluation.
   2. No major changes to asthma control medication regimen in the past six months, ensuring adherence and intervention outcomes are not confounded by treatment changes.
4. Poor Medication Adherence:

   Identified using the Medication Adherence Report Scale (MARS-10), with an average score \<4.5, indicating suboptimal adherence.
5. Presence of Anxiety Symptoms:

   1. Confirmed through the Hamilton Anxiety Rating Scale (HAMA), with a score ≥14, indicating clinically significant anxiety.
   2. 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.
6. Ability to Communicate by Phone:

   Participants must have stable access to a phone and be willing to engage in telephone-based psychological interventions.
7. Stable Health Condition:

Asthma status must be stable, with no acute exacerbations or significant changes in the past month.

Exclusion Criteria:

1. Severe Psychiatric or Cognitive Disorders:

   1. 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.
   2. Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or adherence to the intervention.
   3. Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.
2. 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.
3. Severe Comorbidities:

   1. 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.
   2. Chronic diseases requiring long-term systemic corticosteroid therapy, such as rheumatic or autoimmune diseases, that may interfere with ICS treatment and study outcomes.
4. Pregnancy or Lactation:

   Pregnant or breastfeeding women are excluded due to the unclear risks of ICS treatment and anxiety management interventions in these populations.
5. 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.
6. 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.
7. Incompatibility with Telephone-Based Interventions:

   Inability to reliably receive or engage in telephone-based psychological interventions due to hearing impairments, communication barriers, or other reasons.
8. Adverse Reactions to Psychological Interventions:

   Documented refusal of or adverse reactions to psychological interventions, such as phone-based relaxation or motivational interviewing, that could affect the feasibility and effectiveness of the study.
9. History of Major Surgery or Hospitalization:

History of major surgery or hospitalization (unrelated to asthma) within the past six months that might impact current health status and introduce bias into the study outcomes.

Primary outcomes:
measure: ICS Adherence
timeFrame: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
Secondary outcomes:
measure: Anxiety Levels
timeFrame: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Depression Levels
timeFrame: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Asthma Control Levels
timeFrame: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Asthma-Related Quality of Life
timeFrame: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, and 3-month follow-up.
measure: Intervention Adherence
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8.
measure: Asthma Exacerbation Events
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Frequency of Emergency Department Visits
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Frequency of Hospitalizations
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Occurrence of Respiratory Failure
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Use of Non-Invasive Ventilation
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: ICU Admission and Intubation
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Systemic Steroid Use
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
measure: Length of Hospital Stay
timeFrame: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.
Other outcomes:
Locations:
city: Harbin
country: China
facility: Second Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: Anhui Chest Hospital
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
Study officials:
References: