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临床试验/NCT06852885
NCT06852885已完成不适用

Evaluation of a Food Access Program on Inpatient Nutrition, Recovery, Cost of Care, and Health Related Quality of Life in Selected Public Hospitals in Rwanda

Solid'Africa4 个研究点 分布在 1 个国家目标入组 794 人开始时间: 2024年5月28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
794
试验地点
4
主要终点
Nutritional status

研究概览

简要总结

The purpose of this interventional study was to evaluate outcomes for Solid'Africa's Gemura feeding program in four selected public hospitals comparing results between patients receiving and patients not receiving the feeding program. The study measured the effects of the program on patients nutritional status, recovery during hospitalization, patient health related-quality of life, patient satisfaction, and patient costs of care. Participants were asked: (1) to eat meals provided three times a day if they were in the intervention group; (2) to participate in an intake and discharge survey; and (3) to participate in a daily food intake survey.

详细描述

A multi-center, quasi-experimental study using difference-in-differences controlled comparison to test the outcomes of Solid'Africa's Gemura feeding intervention in four selected public hospitals (two in intervention group and other two in control group) from urban and peri-urban areas targeting socioeconomically vulnerable inpatients. This study has a primary outcome which is nutritional status as measured by body mass index (BMI), and secondary outcomes which include recovery during hospitalization, patient health-related quality of life (HRQOL), patient satisfaction, and patient costs of care.

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

入选标准

  • •Hospital inpatients
  • •Vulnerable socioeconomic status according to social worker assessment
  • •Most inpatient categories
  • •Voluntary, self-feeding ability
  • •Able to stand on scale, with help if needed

排除标准

  • •Hospital outpatients
  • •Patients not determined socioeconomically vulnerable by social worker
  • •Pregnant women hospitalized for delivery
  • •Patients undergoing special treatment for malnutrition
  • •Patients receiving enteral or parenteral nutrition treatment
  • •Patients receiving any kind of artificial feeding support
  • •Patients unable to stand on scale to measure weight

研究组 & 干预措施

Gemura

Experimental

The intervention of the Solid'Africa Gemura selective feeding program will be administered as usual for study participants in the two intervention sites. Eligible hospital inpatients will receive three meals a day during their hospital stay, as prescribed by hospital nutritionists for their specific conditions and ordered from Solid'Africa. The Solid'Africa team will prepare the ordered meals in their off-site kitchen in Rusororo and deliver them daily to the hospitals where the meals will be distributed to the study participants. Meal caloric and nutritional content information is standardized except upon request. The normal meal is 575g of food consisting of 2300kCal with 300g of carbohydrates, 175g of protein, and 100g vitamins/minerals. In addition, Solid'Africa will adjust meal content per nutritionist request for specific needs like low salt/sugar, etc.

干预措施: Meals (Other)

Control

No Intervention

This arm includes inpatients meeting the same eligibility criteria as the intervention arm. However, no intervention will be offered and these patients will experience a hospital stay as usual.

结局指标

主要结局

Nutritional status

时间窗: Baseline and final day of patient stay, on average day 5

Nutritional status will be measured anthropometrically in terms of weight-for-height for all participants to calculate body mass index (BMI = kg/m2). Weight will be measured with a digital weight scale and height will be measured in recumbent position for patients unable to stand and in a standing position for other patients using a height board or a tape measure. Nutritional status will also be classified at baseline and at endline, with BMI \< 18.5 considered underweight, 18.5-24.9 normal weight, 25.0-29.9 overweight, and 30.0+ obese.49 Underweight will be further classified as standard for adults and for children. For children, chronic malnutrition or stunting (low height for age) and acute malnutrition or wasting (low weight for height) will be defined according to the World Health Organization growth charts and classification standards.

次要结局

  • Length of Stay(Baseline and final day of patient stay, on average day 5)
  • Treatment outcome(Final day of patient stay, on average day 5)
  • Costs of treatment(Final day of patient stay, on average day 5)
  • Patient satisfaction(Final day of patient stay, on average day 5)
  • Health-related quality of life(Final day of patient stay, on average day 5)

研究者

发起方
Solid'Africa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefanie Weiland

Principal Investigator

Solid'Africa

研究点 (4)

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