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临床试验/NCT02825927
NCT02825927已完成不适用

Swallowing Function, Oral Health, and Food Intake in Old Age

Umeå University2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
2
主要终点
Swallowing function

研究概览

简要总结

The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.

详细描述

The present study aims to investigate the effects on swallowing function of a specific rehabilitation program with oral screen in the elderly population included. The present study is a part of an on-going cross-sectional, descriptive project called SOFIA where approximately 400 elderly individuals, admitted to short-term care (from the five regions/county Dalarna, Gävleborg, Örebro, Värmland and Västerbotten in Sweden), will be included. The purpose of the overall project is to gain a broader understanding of aspects of dysphagia, eating, oral health, and quality of life and care among elderly people in short-term care facilities.

In the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity <10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. The participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. A control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status.

Cluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. Participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at.

The investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity.

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
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

  • Admitted to short-term care facility ≥ 3 days
  • Included in the overall project SOFIA and with a swallowing capacity <10ml/sec

排除标准

  • Incapable of making decisions

研究组 & 干预措施

Intervention group

Experimental

Intensive training with oral screen for 5 weeks.

干预措施: Oral screen (Other)

Control group

No Intervention

The control group is not offered any intervention.

结局指标

主要结局

Swallowing function

时间窗: Baseline, 5 weeks and 6 months post-intervention

Change in swallowing function measured by the Swallowing Capacity Test (SCT) combined with a teaspoon test. Comparisons between intervention-and control group will be made.

次要结局

  • Quality of life related to swallowing(Baseline, 5 weeks and 6 months post-intervention)
  • Oral Health(Baseline, 5 weeks and 6 months post-intervention)
  • Food Intake(Baseline, 5 weeks and 6 months post-intervention)
  • Activity of daily living(Baseline, 5 weeks and 6 months post-intervention)
  • Quality of life related to oral health(Baseline, 5 weeks and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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