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AsthmaRAMICSNCT06732141

Remote Anxiety Management for ICS-resistant Asthma Study

A study testing Personalized Telephone-Based Psychological Support in people with Asthma, run by First Affiliated Hospital of Ningbo University at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Asthma
What is being tested?
Personalized Telephone-Based Psychological Support
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
11 sitesChina
Study dates
13 Dec 2024to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Stable Health Condition:
  • Asthma status must be stable, with no acute exacerbations or significant changes in the past month.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

China11 sites, 11 recruiting
  • Second Affiliated Hospital of Harbin Medical University

    Harbin

    Dongju Su, 0451-86605222, hydsdj@126.com

    Recruiting
  • Anhui Chest Hospital

    Hefei

    Wenjuan Xia, 0551-63633507, wenjuanx616@163.com

    Recruiting
  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Ran Wang, 0551-62922114, wangran@ahmu.edu.cn

    Recruiting
  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

    Jing Ye, 0551-63869420, plowchan@126.com

    Recruiting
  • Jingzhou Central Hospital

    Jingzhou

    Li He, 0716-8438516, hehel82@163.com

    Recruiting
  • Haishu District People's Hospital

    Ningbo

    Jinggang Xu, 0574-87559778, 958813728@qq.com

    Not yet recruiting
  • Ningbo Medical Center Lihuili Hospital

    Ningbo

    Biyun Yu, 0574-55836114, ybyfish@163.com

    Recruiting
  • Qianhu Hospital

    Ningbo

    Xingyu Liang, 0574-88490111, dr.liangxingyu@foxmail.com

    Recruiting
  • The First Affiliated Hospital of Ningbo University

    Ningbo

    Chao Cao, 0574-87085151, caocdoctor@163.com

    Recruiting
  • Ninghai County First Hospital

    Ninghai

    Min Ji, 531668993@qq.com

    Recruiting
  • Taizhou Central Hospital

    Taizhou

    Xi Yang, 0576-88526000, yangx0603@tzzxyy.com

    Not yet recruiting

Other trials in China

About this study

Official title: Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled 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.

Conditions
Asthma
Being tested
Personalized Telephone-Based Psychological Support, Standard Care with Weekly Follow-Up Calls
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Telephone-Based Psychological SupportBehavioural

    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.
  • Standard Care with Weekly Follow-Up CallsBehavioural

    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.

Study groups in NCT06732141
Study groupRoleWhat they receive
Personalized telephone-based psychological supportExperimentalParticipants 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).
Receives: Behavioral: Personalized Telephone-Based Psychological Support
Standard Care with Weekly Follow-Up CallsPlacebo 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.
Receives: Behavioral: Standard Care with Weekly Follow-Up Calls

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

Secondary outcomes (14)
  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  5. Incidence of Serious Adverse Events (SAEs)

    The safety of the intervention will be assessed by monitoring and recording the incidence of treatment-emergent serious adverse events (SAEs) using the Serious Adverse Event Report Form (SAE Report). The research team will document, analyze, and provide appropriate medical responses to any incidents related to the intervention.

    Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, and 3-month follow-up.

  6. Intervention Adherence

    Intervention adherence will be assessed using the Intervention Participation Record, documenting whether participants complete each scheduled telephone session. For the intervention group, adherence to weekly components such as medication education, PMR, and MI will be tracked. For the control group, participation in routine follow-up calls will be recorded.

    Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8.

  7. Asthma Exacerbation Events

    Asthma exacerbation events will be assessed using the Asthma Exacerbation Record, documenting the time, frequency, and severity of each episode. Severity will be graded as mild, moderate, or severe based on international asthma management guidelines. The intervention's effectiveness in reducing exacerbation events will be analyzed.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  8. Frequency of Emergency Department Visits

    The number of emergency department visits due to asthma exacerbations will be tracked using patient self-reports and verified through medical records. This measure assesses the effectiveness of the intervention in reducing the reliance on acute emergency care.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  9. Frequency of Hospitalizations

    The number of hospital admissions due to asthma exacerbations will be documented, including details such as length of stay and treatments administered. This outcome evaluates the intervention's impact on reducing the necessity for inpatient care.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  10. Occurrence of Respiratory Failure

    Documentation of respiratory failure events during hospital stays, including clinical criteria for diagnosis and management details.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  11. Use of Non-Invasive Ventilation

    Documentation of the use of non-invasive ventilation during hospitalization, including indications and duration of use.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  12. ICU Admission and Intubation

    Records of ICU admissions and whether intubation was required during hospitalization, including associated clinical details.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  13. Systemic Steroid Use

    Documentation of systemic corticosteroid use during hospital stays, including dosage and duration.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

  14. Length of Hospital Stay

    Total duration of each hospital stay will be recorded to assess the impact of the intervention on hospitalization length.

    Measured: Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start13 Dec 2024
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732141
Sponsor's protocol ID
2024-141A-02
Acronym
RAMICS
Status last verified
Jun 2026
First submitted
9 Dec 2024
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Telephone-Based Psychological Support in people with Asthma, run by First Affiliated Hospital of Ningbo University at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Cao (+86-0574-87089878, caocdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICS Adherence (time frame: Baseline, Week 4 (mid-intervention), Week 8 (end of intervention), and 3-month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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RAMICS Clinical Trial NCT06732141 | AzTrials