Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 9
- 主要终点
- Health Outcome - Quality of Life
研究概览
简要总结
This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice
详细描述
This study is a multi-centre, randomized controlled trial comparing a web-based (Smart phone mobile device, tablet and/or personal computer PC) asthma action plan application to best practice/usual care within an asthma program. A third external comparator arm will compare participants to all patients with asthma in Ontario using data obtained from the Ontario Asthma Surveillance Information System (OASIS) cohort, created from administrative data sets within the Institute for Clinical Evaluative Sciences (ICES). Subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. The study will enrol approximately 400 patients in total at all study sites.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma
- •Age 18 of age or older
- •Familiar with web technology
- •Provide consent
- •Understand/read/write English
排除标准
- •Indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Bronchiectasis)
研究组 & 干预措施
Administrative data set
Health services use will be evaluated comparatively against our intervention population and our control and we will include health services utilization data from one year prior randomization.
Written self-management action plan
Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.
干预措施: mobile & web-based action plan (Behavioral)
mobile & web based action plan
Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.
干预措施: mobile & web-based action plan (Behavioral)
结局指标
主要结局
Health Outcome - Quality of Life
时间窗: 6 months
Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice.
次要结局
- Quality - Health Care Utilization(1 year)
研究者
Chris Licskai
Associate Professor of Medicine, University of Western Ontario
Lawson Health Research Institute