Asthmatuner a Self-management App for Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
Primary aim: Evaluating the effect of Asthmatuner on patients´ self-reported asthma control test (ACT/C-ACT)compared with conventional asthma management.
Secondary aim: Evaluating patients´ health-related quality of life (HR-QoL) medical adherence by using Asthmatuner compared with conventional management.
Total sample size: Stratified study population consisting of 43 females and males with diagnosed asthma at the age of at least 6 years pediatric specialist care and 43 females/males in primary care.
Study design: This is a multi-centre, blinded, randomized controlled, cross-over trial over to at least 16 weeks.
Subjects: Two stratified groups of participants with uncontrolled asthma will be recruited; (1) children and adolescents from Astrid Lindgren's Children's Hospital, Karolinska University Hospital, and (2) adolescents and adults from the primary health care sector in Stockholm, Sweden. The asthma control test (ACT/C-ACT) will be applied for evaluation of asthma control, a score less than 20 will be required for inclusion.
Intervention: Asthmatuner is an app supporting self-management evaluating symptoms and lung function with external spirometry. The app gathers the information to define patients´ asthma control. Subsequently, Asthmatuner provides the patient with a treatment recommendation based on the individual treatment plan.
Procedures: Participants are randomized (1:1) into the one of two-arms of asthma self-management with Asthmatuner - conventional or conventional - Asthmatuner. Questionnaires will collect information about asthma control, HR-QoL, Medicine adherence report scale (MARS) and history of medical health concerning health care utilization and personal costs and income.
Analysis: The study hypothesis will be tested by examining difference in patients´ change in asthma control (ACT/C-ACT) and HR-QoL (PAQLQ/Mini-AQLQ). Results will be summarized at each management period as mean scores and analysed by paired t-tests.
详细描述
- Background Clinical gaps hamper proper asthma management, and leads to delayed or undiagnosed disease, poor adherence to treatment, inadequate self-care abilities, inadequate understanding of disease severity, poor patient education, inadequate measurement of lung function, and inconsistent evaluation of symptoms. To improve the patient's ability to self-manage and to overcome clinical gaps, evidence emphasizes clinics to offer comprehensive patient education. The national Finish asthma programme (1994-2004) focused on applying effective strategies of asthma management, as a result, patient's self-management was improved, and cost-effective through limited demands on the health-care and social security system.
Novel applications embodied in smartphones are straightforward alternative to facilitate health care and support patients with hands-on guidance for self-management of asthma. Asthmatuner is a smartphone app that enables evaluation of lung function and symptoms. The app provides patients with a daily treatment plan adjusted for symptoms and lung function. Additionally, information is accessible and can be assessed by health care providers through a back-end system. Future versions of Asthmatuner will be enabled through patient's own medical record. Self-management apps with hands-on guidance for self-management of asthma present a promising future for closing clinical gaps, but the overall benefits of using the service in the treatment of asthma need comprehensive evaluation that answers scientific questions and end-user opinions.
- Aims The primary aim is to evaluate Asthmatuner and the clinical effect on patients´ self-reported asthma control test (scores of ACT/C-ACT).
The secondary aim is to evaluate the effect on patients´ and HR-QoL and medical adherence.
Primary outcomes The primary outcome will be scores of ACT/C-ACT and Paediatric asthma quality of life questionnaire (PAQLQ) or Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate is voluntary.
- •Age > 6 years
- •Diagnosed asthma
- •Asthma control score (ACT/C-ACT) less than 20
排除标准
- •Ongoing comorbidity affecting the health status of asthma
- •Asthma control score (ACT/C-ACT) equal or more than 20
- •Participation in other drug trial
研究组 & 干预措施
Smartphone app - Asthmatuner
The app Asthmatuner contains four different modes;
- Lung function testing with Bluetooth connection of external spirometry
- Symptom evaluation
- Actual treatment plan, based om lung function and symptoms
- Trend views of lung function, symptoms and asthma control
干预措施: Asthmatuner (Device)
Conventional
Conventional treatment and Asthmatuner will be stratified and harmonized into categories of asthma management and current state-of-art at each health care centre. Each group harmonized group will include 43 subjects.
干预措施: Asthmatuner (Device)
结局指标
主要结局
Health-related quality of life
时间窗: 8 weeks
Pediatric asthma quality of life questionnaire/Mini-asthma quality of life quest.
Asthma control
时间窗: 8 weeks
Asthma control test
Adverse events
时间窗: 8 weeks
revision of adverse events
次要结局
- Medical adherence(8 weeks)
研究者
Björn Nordlund
PhD RN
Karolinska Institutet