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临床试验/NCT05815914
NCT05815914招募中不适用

Dietetic Education Support, and Nutrition to Chronic Complex Patients With the Usage of a Telemedicine Tool

Consorci Sanitari Integral2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
182
试验地点
2
主要终点
Changes in nutritional status

研究概览

简要总结

The aim of this clinical trial is to assess the implementation of an APP to track the nutritional status and diet habits of "chronic complex patients"(CCP) in order to improve their nutritional status and evaluate the level of adherence to dietetic counseling.

详细描述

The aim is to evaluate the usage of an APP and track the nutritional status of "chronic complex patients"(CCP) in order to improve their nutritional status.

This is a study of an experimental design, referring to a controlled randomized trial with CCP in the Moises Broggi hospital.In the first stage, there's been an elaboration of the contents of the APP. For the assessment of the strategy of food education, two groups of patients will be defined(Intervention group (IG) & Control group (CG)). In each group there will be 91 subjects, meaning a total of 182 patients. Inclusion criteria: >18 years old, CCP with either malnutrition, or risk of malnutrition (MNA<23,5), therapeutic profile <3, living at home, with full accessibility and capable to use a smartphone, and usual internet consumers (patients or caregivers), and who need to sign the informative consent. The inclusion of this study, will be made through a random sampling and patients will be assigned to IG or CG. All patients will undergo an initial evaluation, a follow-up visit after the first 6 months, and then a final visit after 12 months. The intervention group will also contain an educational, and nutritional program by means of the APP throughout the entire study, and data will be collected through a telematic questionnaire between visits. The variables to study are nutritional, diet, clinics, social and valorisation tools ICT (IG).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

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

  • >18 years old
  • polymorbidity
  • malnourished patient or patient at risk of malnutrition (MNA≤23.5)
  • patient living at home, with access to and able to use a smartphone and regular internet users (patients or caregivers)
  • patient who agrees to participate in the study by signing the informed consent form

排除标准

  • established artificial nutrition
  • advanced dementia
  • admission to a nursing home/social care for a period of >1 month
  • patients not responding to the telematic visits on more than 2 occasions.

结局指标

主要结局

Changes in nutritional status

时间窗: Baseline and 12 months

Assessment of changes in nutritional status through the Mini Nutrition Assessment (MNA) at baseline and at 12 months

次要结局

  • Adherence to the Mediterranean diet(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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