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临床试验/NCT03425435
NCT03425435终止不适用

Quality of Care of Oncological Patients With Home Parenteral Nutrition

Fresenius Kabi1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
143
试验地点
1
主要终点
Patient´s questionnaire

研究概览

简要总结

Medical care for patients with home parenteral nutrition (HPN) is challenging. Among other aspects, the transition from the inpatient to the outpatient setting (discharge management), the organization of HPN at home or in a care facility (care management), the expertise required to care for patients with HPN and consistent compliance with standards are key to the quality of care for patients requiring HPN.

Hospital patients on parenteral nutrition (PN) to be continued at home are often discharged at very short notice. A good interlocking of all players is required to collect and distribute the relevant information, to secure proper training for those involved and to have all utilities and equipment at hand when the patient arrives.

This study collects nutritional and clinical parameters (including patient-reported parameters) along the continuum of care of HPN patients to evaluate the impact of the quality of care of HPN patients on their quality of life.

详细描述

The HPN management will be evaluated by using a self-developed patient and a standardized quality of life questionnaire.

Patients will be recruited at the participating hospital by their treating physician before discharge and will continue their study participation after discharge.

The documentation period for the individual patients will be 3 months.

The questions of the patient´s questionnaire cover areas of interest like: satisfaction with discharge management, nutrition, satisfaction with HPN.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women with an initial prescription for HPN during the current hospital stay
  • Planned PN must at least contain the macronutrients glucose and amino acids.
  • Solid, malignant tumor
  • Anticipated duration of the HPN is at least 28 days
  • Age ≥18 years
  • Full legal capacity or legal guardian available
  • Fluent in German language
  • Able to read and write in German language
  • Signed patient informed consent form
  • Indication for PN

排除标准

  • Contraindication for PN
  • ECOG performance status >3
  • Pregnant and breast-feeding women
  • Concurrent participation in another clinical study that requires deviations from the hospital's routine PN, nutrition and/or nursing procedures

结局指标

主要结局

Patient´s questionnaire

时间窗: Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital

Mean changes in total scores of QoL-questionnaire from baseline.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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