An interventional study of Education in Dementia, Nutrition and Nutrition Deficiency Due to Insufficient Food, sponsored by Manisa Celal Bayar University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Manisa Celal Bayar University · Not applicable, Interventional, and Supportive care
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.
2,231 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 89 is close to the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →Manisa Celal Bayar University is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Inclusion criteria for caregivers
Exclusion criteria for caregivers -wanting to quit working, not attending training
Inclusion criteria for patients
Exclusion criteria for patients
-Having a health condition that affects nutrition
caregivers in the intervention group (n=45) received an individualized educational program intervention
Other: Education
Caregivers in the control group (n=44) continued to receive routine care.
caregivers in the intervention group received an individualized educational program intervention. The content of the educational program was developed by the researcher through a review of the literature and interviews with caregivers. The educational program, during three months, was delivered in 6 sessions of 40 minutes each. The topics of the training content were as follows: 1. General Nutrition Information, 2. Changes Affecting Nutrition During Old Age and Nutrition Principles, 3. Anthropometric Measurements and Scans, 4. Nutritional Problems in the Patient with Dementia, Dementiamendations for Increasing Nutritional Intake in Dementia Patients, 6. Alternatives for Severe Feeding Problems. Covering general topics was held as group education; carried out in two separate groups. Another individual session was planned for caregivers who could not attend the group education program, and the missing topics were completed.
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale
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
Time frame: Four months
Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS)
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
Time frame: Four months
The Mini Nutritional Assessment (MND) Test
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 \&
Time frame: Four months
The Sarcopenia Screening Test (SARC-F)
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.
Time frame: Four months
BMI
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.
Time frame: Four months
Plan to share: No — The data may be shared with individual researchers upon request after the study has been completed and published; however, for data security reasons, sharing the data before publication is not being considered.
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Manisa Celal Bayar University