Evaluate the Clinical Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on the Self-management and Outcomes of Poorly-controlled Asthma: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)
研究概览
简要总结
Asthma is the disease being studied. The main objective of this study is to assess the clinical efficacy of mobile phone short message service (SMS) reminder and consultation on the self-management and outcomes of poorly controlled asthma which is first diagnosed in a time period of 3 months. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed intervention.
Aims: The main aim of this study is to assist asthma patients to practice asthma self-management at home by sending reminders and responding to patients' consultations with mobile phone short message service (SMS), which will eventually help them to control their asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to improve patient health outcome via enhancing patient-physician interaction through mobile phone short message service (SMS) that is low-cost and could be followed easily by the patients and their physicians.
The hypothesis is that asthma patients who receive weekly text message reminders to educate them and reinforce adherence will have better asthma outcome, such as asthma control, while the intervention integrating patient consultation and reminders by SMS improve asthma outcome even more. The investigators further hypothesize that these subjects under intervention will have an improvement in secondary measures including quality of life and patient satisfaction. The investigators also anticipate that such an approach in asthma management will be cost-effective.
详细描述
After examined for their eligibility and recruited into this study at outpatient service, all participants have their case records which contain their baseline data and receive the same standard asthma education(including basic knowledge about asthma, how to use their medicine, what to do when an asthma attack happens and when to come back for their disease review and so on). Each patient is given a paper asthma diary and a peak expiratory flow(PEF) measurer for free. In addition, they are told what intervention they will receive and revised face-to-face one month after the beginning of intervention. After the 3-month study period, when they return to the hospitals, they will return the asthma diaries, be asked to fill in the questionnaires and take pulmonary function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosed uncontrolled or partly-controlled asthma by Global Initiative for Asthma(GINA) standard.
- •At least 6 months asthma history.
- •Ownership of a mobile phone and currently using the text messaging service.
- •Age between 18 and 65 years old.
- •Willingness to participate in this study.
- •Willing to sign the written informed consent to take part in the study.
排除标准
- •Inability to provide written informed consent or to fill in the paper asthma diary.
- •A history of smoking cigarettes for greater than ten pack years.
- •Other current or a history of severe comorbidity.
- •Being in other clinical trials.
结局指标
主要结局
score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)
时间窗: 3 months
score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months
change in asthma control measured by Asthma Control Test(ACT)
时间窗: 3 months
change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.
次要结局
- asthma control(3 months)
- Mini-asthma quality of life questionnaire (mini-AQLQ)(3 months)
研究者
songlq
vice director of department of respirotary and critical care medine
Xijing Hospital