ISRCTN69957256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
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), executive center: Robert Bosch Hospital0 个研究点目标入组 240 人开始时间: 2015年7月28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
- 240
研究概览
简要总结
2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31039754 (added 02/05/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria patients:
- •1. Hip or pelvic fracture if not older than 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 T1b 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
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