Assessment of Asthma Management in Children Over 6 Years of Age and Their Caregivers. Implications for the Implementation of the SMART Strategy in Pediatrics.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 428
- 主要终点
- Change in Correct inhaler technique
研究概览
简要总结
The goal of this study is to see if a short educational session and demonstration by a nurse can help asthmatic children (6-17 years-old), under hospital control, to manage their asthma better, to use their inhaler correctly, and to know when it should be used.
The main question it aims to answer is how much improvement is reached on asthma self-management. The comparison group is the same group. Researchers will compare results before and after educational intervention.
详细描述
The goal of this study is to see if a short educational session and demonstration by a nurse can help children manage their asthma better, use their inhaler correctly, and know when it should be used.
The study lasts about six months and has two visits:
Visit 1:
Participants will do the usual breathing tests, will show the nurse how to use the inhaler, and answer a few short questionnaires.
Then, the nurse will give some practical education using pictures and demonstrations. She will explain the right way to use the inhaler, to know the device, go over when and why to use inhaled medicine, and teach the participant how to recognize when asthma is getting worse and what can participant do about it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of asthma.
- •Prescribed treatment with inhaled corticosteroid.
- •First-degree relative of the patient.
排除标准
- •. Inability to understand Spanish.
研究组 & 干预措施
Study population will be pediatric patients with a diagnosis of asthma, scheduled for consultation
The included population will undergo an objective assessment with pulmonary function tests and will be given questionnaires to evaluate their knowledge about asthma treatment. Afterwards, they will receive a brief educational intervention and will be scheduled for a follow-up visit at 6 months to reassess pulmonary function parameters and knowledge level.
干预措施: Educational Intervention (Other)
结局指标
主要结局
Change in Correct inhaler technique
时间窗: From the nursing intervention until the following 6 months.
For the qualitative variable "inhaler technique," the Inhaler Technique Questionnaire (InTeQ), validated in pediatrics for the use of pressurized inhalers, will be used. This questionnaire includes 5 items considered critical, with an additional item, "shake the device," added for those using pMDIs. The 5 critical steps assessed are: exhale completely before inhalation, close lips firmly, inhale deeply, hold breath afterward, and exhale slowly, which are applicable to both pressurized metered-dose inhalers (pMDI) with a spacer and dry powder inhalers (DPI). The item "device activation" was removed, as it is inherent to the procedure and to facilitate practical applicability.
次要结局
- Change in Treatment Adherence(From the nursing intervention until the following 6 months.)
研究者
Victòria Morón Faura
Principal Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau