ISRCTN41238563已完成未知
Randomized controlled trial of a mobile phone-based telemonitoring application for self-management and clinical decision support for patients with complex chronic conditions
niversity Health Network0 个研究点目标入组 96 人开始时间: 2016年8月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29162557 protocol 2021 Preprint results in https://doi.org/10.2196/31754 results in preprint (added 20/12/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All participants:
- •1. Adults (age 18 years or older)
- •2. Diagnosed with HF, COPD, CKD, and/or uncontrolled hypertension (individuals with diabetes who require blood glucose monitoring will be included as a co-morbidity only if patients have at least one of the above four chronic illnesses, and will be in the form of self-care support only)
- •3. Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application
- •4. Ability to comply with using the telemonitoring system (e.g, able to stand on the weight scale, able to answer symptom questions, etc)
- •Primary chronic disease-specific criteria:
- •1. Patients with HF as the primary chronic disease: with reduced ejection fraction (EF<0.40)
- •2. Patients with COPD as the primary chronic disease: spirometrically confirmed diagnosis of COPD of GOLD Stage II or higher (defined as post-bronchodilator FEV1 < 80% predicted and FEV1/FVC ratio < 70%); smoking history of = 20 pack-years or homozygous alpha-1 antitrypsin deficiency; and prescribed an action plan for the early self-treatment of acute exacerbations
- •3. Patients with CKD as the primary chronic disease: Grade 3-5 (eGFR < 60mL/1.73 m2)
- •4. Patients with uncontrolled hypertension as the primary chronic disease: For non-diabetics: blood pressure >=140/90 mmHg auscultatory (manual measurement) or >=135/85 mmHg oscillometric (automated measurement). For diabetics: blood pressure >=130/80 mmHg
排除标准
- •1. Patients on mechanical circulatory support
- •2. Patients on the heart transplant list
- •3. Terminal diagnosis with life expectancy < 1 year
- •4. Dementia or uncontrolled psychiatric illness
- •5. Resident of a long-term care facility
研究者
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