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临床试验/NCT04880824
NCT04880824已完成不适用

Analysis of the Pathophysiology of Frailty Syndrome and Clinical Development of Frailty Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)

Charite University, Berlin, Germany27 个研究点 分布在 1 个国家目标入组 693 人开始时间: 2021年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
693
试验地点
27
主要终点
Frailty

研究概览

简要总结

The patients included in PRÄP-GO and the corresponding comparison cohorts will be offered to participate in this complementary study in order to be able to carry out a detailed characterization and phenotyping of the frailty complex.

Amendment vote of 08/05/2024: Recruitment extension of Non-frail surgical control group (NFC cohort) until August 31, 2025.

详细描述

As part of the innovation fund project PRÄP-GO (EA1/225/19), a multimodal intervention is being conducted in patients with a frailty syndrome. However, the health care research project is limited to evaluating clinical issues only. In order to be able to research further pathophysiological, clinical, psychosocial and work-organizational connections, different groups of participants will be offered the participation in this scientific support program of PRÄP-GO.

The groups of participants in this accompanying program ANA-PRÄP-GO are:

  • Randomized study patients with a frailty syndrome of the intervention study PRÄP-GO (PG cohort)
  • Non-frail surgical control group (NFC cohort)
  • Non-surgical comparison group (NO cohort)
  • Participants with health professions (GB cohort)

Additionally, relatives of the patients can be included.

Subprojects are included to reflect research questions of interest in sub groups:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Frailty

时间窗: Up to 1 year

Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)

Neuro-cognitive disorder (NCD)

时间窗: Up to 1 year

Frequency of neuro-cognitive disorder (mild / major NCD)

次要结局

  • Number of Participants with Delirium as Determined by Chart Review(During the hospital stay, an expected average of 1 week)
  • Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)(During the hospital stay, an expected average of 1 week)
  • Confusion Assessment Method Severity-Score (CAM-S Long Form) in English(During the hospital stay, an expected average of 1 week)
  • Ethical aspects(Up to 1 year)
  • Findings of Memory consultation(Up to 1 year)
  • Neuroimaging(Up to 1 year)
  • Demand of health services(Up to 1 year)
  • Sarcopenia(Up to 1 year)
  • Quality of life(Up to 1 year)
  • Cholinesterases 1(Up to 1 year)
  • Delirium Rating Scale Revised 98 in English (DRS-R-98)(During the hospital stay, an expected average of 1 week)
  • Delirium Severity Scale (CAM-ICU-7) in English(During the hospital stay, an expected average of 1 week)
  • Cardiovascular function 2(Up to 1 year)
  • Incidence of delirium(During the hospital stay, an expected average of 1 week)
  • Nursing Delirium Screening Scale (Nu-DESC)(During the hospital stay, an expected average of 1 week)
  • Cardiovascular function 1(Up to 1 year)
  • Patient-related outcome measures (PROMS)(Up to 1 year)
  • Incidence of cognitive impairment(Up to 1 year)
  • Severity of delirium(During the hospital stay, an expected average of 1 week)
  • Confusion Assessment Method (CAM)(During the hospital stay, an expected average of 1 week)
  • Intensive Care Delirium Screening Checklist (ICDSC)(During the hospital stay, an expected average of 1 week)
  • Patient-related experience measures (PREMS)(Up to 1 year)
  • Incidence of dementia(Up to 1 year)
  • Calf circumference(Up to 1 year)
  • Arm circumference(Up to 1 year)
  • Number of participants with changes in laboratory values 2(Up to 1 year)
  • APOE polymorphisms(Up to 1 year)
  • Total interleukin-8(Up to 1 year)
  • Delirium days(During the hospital stay, an expected average of 1 week)
  • COVID-19(Up to 1 year)
  • Patient satisfaction(Up to 1 year)
  • Insomnia(Up to 1 year)
  • Dental status(Up to 1 year)
  • Stress(Up to 1 year)
  • Anxiety 1(Up to 1 year)
  • Anxiety 2(Up to 1 year)
  • Nutritional Status(Up to 1 year)
  • Number of participants with changes in laboratory values 1(Up to 1 year)
  • Autophagy of platelets(Up to 1 year)
  • Biomarker panel(Up to 1 year)
  • Vitamin D (cholecalciferol)(Up to 1 year)
  • Analysis of urine(Up to 1 year)
  • Hip Osteoarthritis Outcome(Up to 1 year)
  • Skill management(Up to 1 year)
  • Electroencephalography band power(During the hospital stay, an expected average of 1 week)
  • Adverse events(Up to 1 year)
  • Adherence to Mediterranean diet (MD)(Up to 1 year)
  • Psychometric properties of the Meta Memory questionnaire(During the hospital stay, at the beginning of the investigation, an average of two hours.)
  • Postoperative complications(Up to 30 days)
  • HbA1c(Up to 1 year)
  • Cholinesterases 2(Up to 1 year)
  • Intracellular pH(Up to 1 year)
  • Multiplex gene expression analyzes (neuroinflammation and micro RNA panels)(Up to 1 year)
  • Autoantibodies(Up to 1 year)
  • Trypotophan metabolites and short-chain fatty acids(Up to 1 year)
  • Peripheral Blood Mononuclear Cell(Up to 1 year)
  • Protein panel(Up to 1 year)
  • Serum albumin(Up to 1 year)
  • Sciatica Bothersomeness Index(Up to 1 year)
  • Depth of anesthesia(During surgery, an expected average of 2 hours)
  • Cytokines(Up to 1 year)
  • Chemokines(Up to 1 year)
  • Markers immune-brain axis and gut-brain axis(Up to 1 year)
  • Analysis of microbiome(Up to 1 year)
  • Gait analysis 1(Up to 1 year)
  • Gait analysis 2(Up to 1 year)
  • Clinical investigation(Up to 1 year)
  • Oswestry disability index (ODI)(Up to 1 year)
  • Microbiome 1(Up to 1 year)
  • Microbiome 2(Up to 1 year)
  • Dementia markers(Up to 1 year)
  • Biobanks samples(Up to 1 year)
  • Range of Motion of the hip/knee(Up to 1 year)
  • Hip abduction force (for total hip arthroplasty patients)(Up to 1 year)
  • Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)(Up to 1 year)
  • Knee Osteoarthritis Outcome(Up to 1 year)
  • Knee extension and flexion force measurement (for total knee arthroplasty patients)(Up to 1 year)
  • Back pain(Up to 1 year)
  • Modified Japanese orthopaedic association scale(Up to 1 year)
  • ASIA Impairment Scale (AIS)(Up to 1 year)
  • Leg pain(Up to 1 year)
  • Acceptance of participatory decision-making(Up to 1 year)
  • Electroencephalography spectral analysis(During the hospital stay, at the beginning of the investigation, an average of one hour.)
  • Effect of analgesics(During the hospital stay, an expected average of 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Charite University, Berlin, Germany

研究点 (27)

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