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临床试验/NCT04933929
NCT04933929已完成不适用

Personalized Dietary Advice 3 Months After Discharge From Hospitalization in Geriatrics: Effect on Nutritional Status According to Coronavirus Disease 2019 (Covid-19) Status (Positive or Negative) During Hospitalization

Gérond'if1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups.

研究概览

简要总结

The principal aim of this interventional, multicentre study is to compare the impact of a follow-up by monthly telephone dietetic consultations, started 3 months after discharge from hospital, for a period of 3 months, on the energy intake in patients elderly people recently hospitalized for Coronavirus disease 2019 (Covid-19), Coronavirus disease Positive group "Covid (+)", or not, Coronavirus disease Negative group"Covid (-)".

The main outcome measure is to compare the total energy intake at 6 months, after 3 months of dietary consultations, between Coronavirus disease Positive group "Covid (+)" and Coronavirus disease negative group "Covid (-)".

详细描述

This study consists of nutritional monitoring after hospitalization, carried out by dieticians. Consultations are done remotely, by phone only.

Eligible subjects are included, either upon discharge from hospital or within 3 months (at the latest) following their hospitalization.

135 subjects will be included, 50% will be included in Coronavirus disease Positive group "Covid (+)" and 50% in the Coronavirus desease negative group "Covid (-)" .

The following data will be collected

  • At Inclusion (D0): Average length of hospital stay, medical diagnoses, severity of hospital stay, autonomy and dependency scores, albumin and body mass index (BMI).
  • At M3, M4, M5 and M6: Dietary monitoring data, patient's vital status and dependency scores.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Patient hospitalized or having been hospitalized in acute geriatrics
  • •Living at home 3 months after hospitalization in acute geriatrics
  • •Having a good understanding of the French language
  • •Being able to understand the study information and participate in telephone follow-up
  • •Having read the information notice and agreeing to participate in the study
  • •For the Covid (+) group: hospitalized for Covid-19 (diagnostic confirmation by positive RT-PCR)
  • •For the Covid group (-): hospitalized for any other reason (negative RT-PCR)

排除标准

  • •Patient refusing to participate in the study
  • •Subject to a legal protection measure (curatorship, guardianship or safeguard of justice)
  • •With cognitive impairment making it impossible to understand the study protocol and express consent.

研究组 & 干预措施

Coronavirus disease Positive group "Covid (+)"

Experimental

Positive PCR test.

干预措施: Post-hospitalization nutritional monitoring (Behavioral)

Coronavirus disease Negative group "Covid (-)"

Active Comparator

Negative PCR test.

干预措施: Post-hospitalization nutritional monitoring (Behavioral)

结局指标

主要结局

Comparison of total energy requirements, after 3 months of dietary consultations, between Covid (+) and Covid (-) groups.

时间窗: 6 months

A 30 to 40 minute telephone survey by a dietitian, with: * the reminder of food intake over 24 hours, estimation of the weight of each food and quantification in kcal / day and grams of protein / day. * This assessment of food intake will be followed by nutritional advice adapted to the severity of undernutrition, spontaneous food intake, the subject's tastes and dislikes, and the possibilities of preparing the necessary dishes and textures.

次要结局

  • Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale(At inclusion)
  • Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale(At inclusion)
  • Comparison of weight variation by measuring the Body Mass Index (BMI)(6 months)

研究者

发起方
Gérond'if
申办方类型
Other
责任方
Sponsor

研究点 (1)

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