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临床试验/ISRCTN41238563
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

发起方
niversity Health Network

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