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临床试验/DRKS00008863
DRKS00008863已完成未知

Prevention and Rehabilitation of Osteoporotic Fractures In Disadvantaged Populations 2 – Subproject 3: A multifactorial intervention for osteoporotic fracture patients with incipient to moderate cognitive impairment and their caregivers: A dual-center randomized controlled trial - PROFinD 2

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)0 个研究点目标入组 240 人开始时间: 2015年7月17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
240

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
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
65 Years 至 one(—)
性别
All

入选标准

  • Inclusion criteria patients: (1) hip or pelvic fracture during the last 3 months, (2) community-dwelling, (3) 4 m independent walking with walking aid, (4) age: 65 years and older, (5) cognitive impairment defined by having a Mini-Mental State Examination (MMSE) score of 17-26, (6) visual acuity: Snellen fraction =20/400
  • Inclusion criteria caregivers: (1) supports patient = 10.5 hours per week (informal care in ADL, IADL, and supervision), (2) the support is not commercial, (3) = 18 years of age, (4) willing to attend a personal consultation at the patient's home

排除标准

  • Exclusion criteria patients: (1) delirium, (2) severe somatic or mental disease, which doesn’t allow participation, (3) patient is not able to understand and speak German, (4) no telephone available, (5) place of domicile not reachable by public transport in the region of the study center Stuttgart or >50 km away from the study center Heidelberg, (6) assessment T1 cannot be conducted at the person´s home in week 1-6 after rehabilitation, (7) moderate to severe aphasia (amnestic aphasia is not an exclusion criteria) or severe apraxia of speech, (8) progressive, terminal status, (9) insufficient hearing ability to conduct phone calls
  • Exclusion criteria caregivers: (1) current mental illness or cognitive impairment that affects the ability to understand the requirements of the assessments, to participate in the intervention or to give informed consent, (2) no telephone available, (3) insufficient hearing ability to conduct phone calls, (4) not able to understand and speak German

研究者

发起方
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

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