医学
课程
随机对照试验
干预(咨询)
一致性
赫尔辛基宣言
机构审查委员会
赫尔辛基宣言
协议(科学)
家庭医学
宣言
相(物质)
医学教育
护理部
替代医学
外科
知情同意
内科学
病理
心理学
教育学
化学
有机化学
政治学
法学
作者
Christiane Kugler,Hannah Spielmann,M. Seemann,Volker Lauenroth,R. Wacker,Wolfgang Albert,Christine Spitz-Koeberich,Sandra Semmig-Koenze,Maja von Cube,Katharina Tigges-Limmer
出处
期刊:BMJ Open
[BMJ]
日期:2021-05-01
卷期号:11 (5): e044374-e044374
被引量:6
标识
DOI:10.1136/bmjopen-2020-044374
摘要
Self-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The 'SM model for patients on VAD support' will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum.This is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3.Ethical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English.NCT04234230 and NCT04526964; Pre-results.
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