Patient and Treatment related barriers in Management of Asthma – A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- •Appropriateness of prescribed asthma treatment based on 2025 GINA guidelines, along with symptom severity.
研究概览
简要总结
This study will be conducted among patients aged 18 years and above, who have been using any type of inhaler device for at least 6 months visiting the center for the symptomatology or the follow up of asthma. Data will be collected following approval from the Institutional Ethics Committee.
- Eligible patients will be identified during routine outpatient or inpatient visits.
- After informed consent, each patient will be interviewed and assessed in a private setting.
- The following will be completed for each participant:
- Sociodemographic and clinical data entry
- GINA-based severity assessment
- ACT questionnaire
- MGLS and TAI for adherence evaluation
- Direct observation of inhaler technique using device-specific checklists
- The entire interaction will take approximately 25–30 minutes per patient and done in a single visit.
- Common errors in inhaler use and patterns of non-adherence will be documented.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with asthma (as per GINA criteria).
- •On inhaler therapy for at least 6 months.
- •Willing to provide informed consent.
- •Both outpatients and inpatients of asthma.
排除标准
- •Patients with other chronic respiratory diseases other than asthma.
- •Unwilling or unable to complete questionnaire.
- •Patients with language or psychiatric problems that would affect their ability to answer questions.
- •Patients receiving inhalational therapy for other diseases.
- •Patients using only oral therapy (i.e., not on inhalers).
结局指标
主要结局
•Appropriateness of prescribed asthma treatment based on 2025 GINA guidelines, along with symptom severity.
时间窗: Being a cross sectional observational study, the outcomes will be assessed/ estimated only at a single time interval, i.e., at baseline.
•Level of adherence to asthma medication using the Morisky Medication Adherence Scale (MMAS-4) as: Good/Moderate/Low adherence.
时间窗: Being a cross sectional observational study, the outcomes will be assessed/ estimated only at a single time interval, i.e., at baseline.
•Quantitative measurement of adherence to inhalers using the TAI questionnaire, which will help classify adherence as: Good adherence/ Intermediate adherence/ Poor or non-adherence.
时间窗: Being a cross sectional observational study, the outcomes will be assessed/ estimated only at a single time interval, i.e., at baseline.
次要结局
- Proportion of patients demonstrating correct vs. incorrect inhaler technique based on checklists for each device type (MDI, DPI, etc.).(Being a cross sectional observational study, the outcomes will be assessed/ estimated only at a single time interval, i.e., at baseline.)
研究者
Namita Honnutagi
Kasturba Medical College