LifE Style, Nutrition and Oral Health in Care Givers (LENTO)

Study Overview
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Brief Summary
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The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are to study the nutritional status, oral health, coping, functional capacity and quality of life 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 develop an operating model to maintain good nutrition and oral health.

Detailed Description
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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.

Official Title
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LifE Style, Nutrition and Oral Health in Care Givers)

Conditions
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Nutrition Disorders in Old Age, Caries,Dental, Dentures, Oral Mucositis, Tooth Diseases, Plaque, Dental, Gingival Diseases

Intervention / Treatment
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* Other: Nutrition and oral health intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: caregivers who have a caregiver´s contract valid on 1 January 2019 care recipients living at home Exclusion Criteria: in terminal care

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group of nutrition<br>On the basis of a blood test, Mini Nutritional Assessment, food diary and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the caregivers. If the caregivers seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. | Other: Nutrition and oral health intervention<br>* The interventions included individualised nutrition and oral health care.<br>|
| No Intervention: Control group of nutrition<br>The control group has the same examinations as the intervention group, they do not get dietary counseling. | |
| Experimental: Intervention group of oral health<br>After the dental hygienist interview and oral health examination, the caregivers in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. | Other: Nutrition and oral health intervention<br>* The interventions included individualised nutrition and oral health care.<br>|
| No Intervention: Control group of oral health<br>The control group has the same examinations as the intervention group, they do not get oral health counseling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Change in MNA scores | Baseline and 6 months and (12 months follow-up visit) | 
| Albumin | Change in plasma albumin concentration | Baseline and 6 months and (12 months follow-up visit) | 
| Prealbumin | Change in plasma prealbumin concentration | Baseline and 6 months and (12 months follow-up visit) | 
| Body mass index (kg/m2) | Change in BMI | Baseline and 6 months and (12 months follow-up visit) | 
| Hand grip strength | Change in had grip strength of boot hands | Baseline and 6 months and (12 months follow-up visit) | 
| Number and location of teeth | Change in number and location of teeth | Baseline and 6 months and (12 months follow-up visit) | 
| Type and location of removable dental prosthesis | Change in type and location of removable dental prosthesis | Baseline and 6 months and (12 months follow-up visit) | 
| Oral mucosa | Change in oral mucosa | Baseline and 6 months and (12 months follow-up visit) | 
| Condition of teeth | Change in condition of teeth | Baseline and 6 months and (12 months follow-up visit) | 
| Presence of plaque | Change in presence of plaque | Baseline and 6 months and (12 months follow-up visit) | 
| Gingival bleeding and measurement of periodontal pockets | Change in gingival bleeding and measurement of periodontal pockets | Baseline and 6 months and (12 months follow-up visit) | 
| Dental and denture hygiene | Change dental and denture hygiene | Baseline and 6 months and (12 months follow-up visit) | 
| Subjective feeling of dry mouth and pain in mouth | Change in subjective feeling of dry mouth and pain in mouth | Baseline and 6 months and (12 months follow-up visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of Daily Living | Change in Activities of Daily Living (ADL) scores | Baseline and 6 months and (12 months follow-up visit) | 
| Instrumental Activities of Daily Living | Change in Instrumental Activities of Daily Living (IADL) scores | Baseline and 6 months and (12 months follow-up visit) | 
| Quality of Life (WHOQOL) -bref scores | Change in quality of Life (WHOQOL) -bref scores | Baseline and 6 months and (12 months follow-up visit) | 
| Depression | Change in Geriatric Depression Scale (GDS)-15 scores | Baseline and 6 months and (12 months follow-up visit) | 
| Cognition | Change in Mini Mental State Examination (MMSE) scores | Baseline and 6 months and (12 months follow-up visit) | 
| Sense of coherence | Change in sense of coherence (SOC) scores | Baseline and 6 months and (12 months follow-up visit) | 
| Morbidity | Functional Comorbidity Index (FCI) scores | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Oral health, Care givers, Home care clients, Quality of life