ISRCTN41847489已完成未知
PrImary Care management for optimized ANtithrombotic Treatment: a cluster-randomized controlled trial
Federal Ministry of Education and Research (Germany)0 个研究点目标入组 736 人开始时间: 2012年4月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 736
研究概览
简要总结
- 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25344288 2. 2017 results in http://www.ncbi.nlm.nih.gov/pubmed/28166725 3. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31370840 (added 05/08/2019) 4. 2020 results in https://pubmed.ncbi.nlm.nih.gov/32176711/ (added 24/06/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Trial sites (General practices):
- •1. Working as a general practitioner inclusive specialists in internal medicine
- •2. Doctor?s agreement that health care assistants (HCAs) from the practice are allowed to participate in a structured educational course and perform specific case management duties afterwards
- •3. Practice provides health services to persons with German statutory health insurance
- •4. Practice software with the facility to detect eligible patients requiring antithrombotic treatment
- •5. Investigating physician agrees to the contractual obligations of the trial
- •1. All patients (age =18 years)
- •2. Long term indication for oral anticoagulation: atrial fibrillation, recurrent venous thromboembolism, pulmonary embolism, mechanical heart prosthesis and others such as; hereditary coagulopathy, intracardial thrombosis
- •3. Given indication for coumarins, antiplatelet therapies or the new antithrombotic agents rivaroxaban and dabigatran
- •4. Patient is capable to give a free and written informed consent to participate in the trial, to fill in questionnaires and to participate in telephone interviews.
- •5. Care is provided by a general practitioner (GP) working at a trial site (at least one contact in the last 12 months)
- •6. Patient is legally competent to sign any documents
排除标准
- •1. Lack of German language skills
- •2. Diseases causing life expectancy of < 6 months
- •3. Dementia (GPs assessment) [less than score 26 in Mini Mental State Examination (MMSE)]
- •4. Psychosis
- •5. Severe sight disorder or auditory defect
- •6. Alcohol-or drug abuse
- •7. Dementia (less than score 26 in MMSE)
- •8. Residence in institutions e.g. nursing homes or residential care home
- •9. Visits at the practice of the GP not possible, home visits required
- •10. Alcohol-or drug abuse
- •11. Participation in a clinical trial within the last 30 days
研究者
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