DRKS00024723招募中未知
TeNDER - affecTive basEd iNtegrateD carE for betteR Quality of Life - a feasibility trial in Germany (wave 1 and 2) - TeNDER 1 and 2
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 one（—）
- 性别
- All
入选标准
- •Age =60 years;
- •Have a caregiver or reference person.
- •Sufficient cognition capabilities to take informed decisions.
- •Acceptance to participate and have signed the informed consents.
- •Agree to use the provided devices;
- •Understand local language;
- •Ability to walk (with or without walking aids) or able to use wheelchair;
- •Compliance with scenario setting.
- •Patient with Alzheimer Disease accordingly to the NINCDS-ADRDA criteria or diagnosed dementia with MMSE score of 19 to 28;
- •Patients with confirmed diagnosis of Parkinson Disease accordingly to the criteria by United Kingdom Parkinson’s Disease Brain Bank (UKPDSBB) criteria or according to a neurological assessment;
- •Patient that presents one of the following:
- •oCardiovascular failure grade II-III NYHA;
- •oCoronary heart disease: both stable and acute coronary artery disease (ACS) with or without ST elevation;
- •oAtrial Fibrillation;
- •o Cardiac Pacemaker Carrier;
- •oCerebral Stroke;
- •Preserved language comprehension and communication skills.
- •To be able to consent and to comply with at least one of the following requisites:
- •oTo be employed by a public or private company or directly by the patients to provide direct care and thus support daily activities.
- •oTo live with and/or take care of a relative (or other close relationship) affected by Parkinson’s disease or Alzheimer’s disease or/and others dementia or CVD
- •oTo provide logistic support to a family member or a close friend affected by Parkinson’s disease or Alzheimer’s disease or/and others dementia or CVD.
- •Express readiness in the use of technologies to use the devices
- •PROFESSIONALS
- •To be able to consent and to be qualified and working in a medical or social area specialized in the care or support of Parkinson’s, Alzheimer’s or/and dementia and cardiovascular diseases (including general practitioners, nurses, social workers and others).
排除标准
- •Patients whose caregiver is unwilling to participate / assist;
- •Patients / caregivers are unwilling to work with the technologies used in this project.
- •Advanced stages of the disease (for example Alzheimer’s disease: avoid GDS 6-7).
- •Patients with acute stroke in the previous six months (Hachinski scale score > 4);
- •Pyramidal and or Extrapyramidal signs at neurological examinations;
- •Patients’ whom informal carer (family care giver) is not willing to participate/assist;
- •Patients/carer is unwilling to work with technologies used in this project;
- •Advanced stage of disease.
- •Parkinsonism syndromes (Multiple System Atrophy (MSA) Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS)
- •Dementia with Lewy bodies (DLB)
- •Patients with secondary parkinsonisms;
- •Patients’ whom informal carer (family care giver) is not willing to participate/assist;
- •Patients/carer is unwilling to work with technologies used in this project;
- •Advanced stage of disease.
- •Patients’ whom informal carer (family care giver) is not willing to participate/assist;
- •Patients/carer is unwilling to work with technologies used in this project
- •ACS less than 4 weeks ago;
- •Severe aortic stenosis;
- •Severe visual or hearing impairment.
- •Caregivers not able to consent.
- •Caregivers not aware of the daily needs of
- •PROFESSIONALS
- •Not working as a professional involved in the care or support of AD, PD, CVD patients.
- •Working practice and environment not connected to Alzheimer’s’, Parkinson’s’ and other dementias.
- •Conflict of interest.
- •Not to be able to consent.
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