跳至主要内容
临床试验/NCT04003493
NCT04003493已完成不适用

LifE Style, Nutrition and Oral Health in Care Givers)

University of Eastern Finland2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
Condition of teeth

研究概览

简要总结

The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are

  1. to study the nutritional status, oral health, coping, functional capacity and quality of life
  2. to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients
  3. develop an operating model to maintain good nutrition and oral health.

详细描述

In Finland, the aim is to reduce the institutional care of older people and caring them in their own homes. The goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. In order to achieve this goal, it is important to influence the health and performance of caregivers. Information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. A randomly of 220 caregivers over 65 years old and their clients is selected for this study. The caregivers are randomized to either treatment or control groups. At the beginning of the study is estimated the nutritional status and oral health of the caregivers. Based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. After six months, the same measurements are made as at the beginning of the study. Monitoring measurements will be made one year after the start of the intervention. The results of this project provide information on the health, well-being, and ability to the function of the caregivers. Based on the results, is developed an operating model that is intended to be wide as use as possible. Improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • caregivers who have a caregiver´s contract valid on 1 January 2019
  • care recipients living at home

排除标准

  • in terminal care

结局指标

主要结局

Condition of teeth

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in condition of teeth

Presence of plaque

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in presence of plaque

Gingival bleeding and measurement of periodontal pockets

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in gingival bleeding and measurement of periodontal pockets

Dental and denture hygiene

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change dental and denture hygiene

Subjective feeling of dry mouth and pain in mouth

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in subjective feeling of dry mouth and pain in mouth

Oral mucosa

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in oral mucosa

Nutritional status

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in MNA scores

Albumin

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in plasma albumin concentration

Prealbumin

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in plasma prealbumin concentration

Body mass index (kg/m2)

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in BMI

Hand grip strength

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in had grip strength of boot hands

Number and location of teeth

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in number and location of teeth

Type and location of removable dental prosthesis

时间窗: Baseline and 6 months and (12 months follow-up visit)

Change in type and location of removable dental prosthesis

次要结局

  • Instrumental Activities of Daily Living(Baseline and 6 months and (12 months follow-up visit))
  • Activities of Daily Living(Baseline and 6 months and (12 months follow-up visit))
  • Quality of Life (WHOQOL) -bref scores(Baseline and 6 months and (12 months follow-up visit))
  • Depression(Baseline and 6 months and (12 months follow-up visit))
  • Cognition(Baseline and 6 months and (12 months follow-up visit))
  • Sense of coherence(Baseline and 6 months and (12 months follow-up visit))
  • Morbidity(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验