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临床试验/NCT06739642
NCT06739642已完成不适用

Effectiveness of Caregiver Nutrition Education on the Diet of Patient with Dementia: a Randomized Controlled Trial

Celal Bayar University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年1月15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
入组人数
89
试验地点
1
主要终点
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale

研究概览

简要总结

Nutritional problems can and do manifest themselves at various stages and with varying degrees of severity. Patients with dementia are at significant risk for weight loss and malnutrition due to the numerous issues that arise during the disease process. Caregivers of patients with dementia face significant challenges in providing nutritional care for their patients due to difficulties with nutrition for physical, emotional, cognitive, and behavioral reasons.

The following methods were used: This study employed a randomized controlled trial with a pretest-posttest design. The study was conducted with 89 patients and caregivers (45 in the intervention group and 44 in the control group). We collected data from the intervention and control groups before and after the intervention using the Descriptive Information Form, Edinburgh Nutrition Evaluation in Dementia (EdFED) Scale, Mini Nutritional Assessment, Dysphagia Assessment Scale in Multiple Sclerosis, and Sarcopenia Screening Test (SARC-F). The intervention group received a standardized educational program for three months. We evaluated the data using percentages, arithmetic means, standard deviations, medians, and interquartile ranges. We analyzed the data using chi-square tests, Mann-Whitney U tests, Wilcoxon signed-rank tests, and intention-to-treat analyses.

研究设计

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

入排标准

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

入选标准

  • •for caregivers
  • •being a primary caregiver,
  • •aged> 18,
  • •volunteering to participate in the study.

排除标准

  • •for caregivers -wanting to quit working, not attending training
  • •Inclusion criteria for patients
  • •According to DSM-V criteria, they must have a nutritional disorder, metabolic disorder, or dementia that is not due to systematic diseases
  • •be fed orally
  • •have the caregiver/guardian of the patient with dementia voluntarily agree to participate in the research with him/herself and the patient
  • •Exclusion criteria for patients
  • •Having a health condition that affects nutrition

研究组 & 干预措施

Intervention

Experimental

caregivers in the intervention group (n=45) received an individualized educational program intervention

干预措施: Education (Other)

Control

No Intervention

Caregivers in the control group (n=44) continued to receive routine care.

结局指标

主要结局

The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale

时间窗: Four months

The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale developed by Watson (Watson, 1994)helps screen for feeding difficulties in patients with dementia. The scale establishes the behavioural baseline and defines the level of assistance the patient needs. Administration of the scale takes less than five minutes. The first 10 items in the scale address feeding behaviour at meals; Depending on how often each behavior occurs during a feeding, 0 points are given for "never", 1 point is given if it occurs 2 or 3 times a week / "sometimes", and 2 points are given if it occurs more than 4 times a week / " often". The score from the first 10 items ranges from 0 to 20, with 20 being the most serious condition. Points can be used to track change. Finally, item 11 states the level of support the patient needs. The scale was reported to be valid and reliable (Cronbach Alpha coefficient = 0.86) (Uyar et al., 2022). In this study, the Cronbach Alpha coefficient was found to be 0.90 in

Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS)

时间窗: Four months

Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS) was developed by Bergamaschi et al. (2008) for the evaluation of oropharyngeal dysphagia in patients with Multiple Sclerosis (Bergamaschi et al., 2008). In the scale, the dysphagia score for solids is calculated by adding the 1st, 3rd, 4th, 5th, 7th, 8th and 10th items, and the dysphagia score for liquids is calculated by adding the 2nd, 6th and 9th items. Scale items are coded as "No = 0" and "Yes = 1". Scores between 0 and 10 can be obtained from the scale. A score of 1 or above indicates the presence of dysphagia, and a score of 3 or more indicates the presence of severe dysphagia. Turkish validity and reliability study was conducted by Tenekeci et al. and it has been reported that the total scale of Cronbach's Alpha coefficient has been 0.91 (Tenekeci et al., 2018). In this study, the Cronbach Alpha coefficient was in the pre-test 0.85; it was in the post-test 0.86. Although the scale was developed for patients with MS, app

The Mini Nutritional Assessment (MND) Test

时间窗: Four months

The Mini Nutritional Assessment (MND) Test was developed in 1994 in collaboration between the University of TOULOUSE, New Mexico Medical School and Nestle Research Center (Switzerland). MND is widely used in community clinical practice to examine the nutritional status of the elderly and dementia patients. The test consists of 18 items covering anthropometric measurements, dietary behaviours, and global and subjective factors. Malnutrition Indicator Score (MGP) is calculated by summing the preliminary evaluation score and the comprehensive evaluation score. Malnutrition Indicator Score (MGP) can be at least 0 and at most 30. The range of 24-30 points indicates no risk of malnutrition, the range of 17-23.5 points indicates the risk of malnutrition, and scores less than 17 indicate the presence of malnutrition. Mini Nutritional Assessment (MND) is a common screening tool (Guigoz, 2006). Cronbach's alpha coefficient was reported as 0.65 in elderly people with early-stage dementia (Holm \&

The Sarcopenia Screening Test (SARC-F)

时间窗: Four months

The Sarcopenia Screening Test (SARC-F) was developed as a possible rapid diagnostic test for (Malmstrom \& Morley, 2013) questions the individual's assistance needed for weight bearing, walking, getting up from a chair/bed, climbing stairs, and the experience of falling. Scores range from 0 to 10, with 0-2 points for each component. The 0-3 points range represents healthy, and 4 points and above represent sarcopenia and poor outcomes. Its suitability for the geriatric population in Turkey was checked by Kış and Karaca (2021) (Cronbach Alpha coefficient = 0.60) (Kış \& Karaca, 2021). In this study, the Cronbach Alpha coefficient was in the pre-test 0.79; it was in the post-test 0.76.

BMI

时间窗: Four months

In this study, BMI was used to evaluate the nutritional status of the patient with dementia. In a similar study (Salva et al., 2011) in the literature on the nutrition of dementia patients, weight was monitored by mail. Care was taken to ensure that the measurements were made by the instructions and by the same person.

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

Fatma Uyar Açışlı

Phd, Manisa Celal Bayar University, Public Health Nursing Department

Celal Bayar University

研究点 (1)

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