跳至主要内容
临床试验/NCT02567513
NCT02567513已完成不适用

Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial

Vanderbilt University0 个研究点目标入组 154 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
主要终点
Total caloric intake during and between meals

研究概览

简要总结

Low oral food and fluid intake and unintentional weight loss are common problems among long-stay nursing home (NH) residents and are associated with adverse, costly clinical outcomes. This study will use a controlled, intervention design to determine the cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition intervention that offers NH residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents with an order for supplementation will be included in this study and randomized into one of three groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or (3) choice intervention. The usual care control group will continue to receive standard NH care for supplement or snack delivery. Research staff will provide the same supplements used by the NH (group two) or a choice between supplements and other foods and fluids (group three) twice daily, five days per week, for 24 weeks and document the daily costs of intervention implementation when also providing a prompting protocol known to improve intake and enhance independence in eating. Based on extensive preliminary data, it is anticipated that both groups two and three will require significantly more staff time than usual care (group one). Thus, the labor costs of these interventions will be documented and compared to effectiveness measures. Effectiveness measures include the following resident outcomes: improvements in total daily caloric intake, weight, nutrition and hydration status and quality of life. These outcomes will be independently monitored for all three groups across 24-weeks by trained research staff using standardized, validated protocols.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Long-stay nursing home residents,
  • capable of oral food and fluid intake,
  • physician or dietitian order for caloric supplementation.

排除标准

  • Short-stay nursing home residents (rehabilitation),
  • feeding tube,
  • hospice care.

结局指标

主要结局

Total caloric intake during and between meals

时间窗: 24 weeks

Weighed intake methods both during and between meals were used to assess total caloric intake before and after intervention.

次要结局

未报告次要终点

研究者

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

Sandra Simmons

Associate Professor of Medicine

Vanderbilt University

相似试验