Nutritional Education for Dependant Patients

Study Overview
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Brief Summary
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Objective: To assess the effect of a nutritional educational intervention on the risk of malnutrition dependent patients aimed at the caregivers. Material and methods: Intervention study with control group, with 200 patients randomized selected, in a Home Care Program of 5 Primary Care Centers, malnourished and dependents, older than 65 years and with a caregiver. Socioeconomic and cultural characteristics of the patient and the caregiver are collected. Mini Nutritional Assessment (MNA), food intake, anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, hemoglobin, lymphocyte count, iron, ferritin, are evaluates on 0- 6-12 months. Also evaluated dentures, basic activities of daily living (Barthel test), cognitive state (Pfeiffer test) status of mood (Yesavage test). Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses make an initial session for caregivers and monitored the education at home monthly (4 visits) up to 6 months. NANDA (NORTH AMERICAN NURSING DIAGNOSIS ASSOCIATION) specific methodology of the Nursing profession is used. The investigators studied the effect of the intervention on the caregivers on the patient's nutritional status by the MNA test, diet, anthropometry and biochemical parameters. Bivariate normal test statistics and multivariate models were created to adjust the effect of the intervention. The program SPSS / PC was used.

Official Title
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Intervention of Nutritional Education Addressed to Carers of Dependant Patients

Conditions
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Risk of Malnutrition

Intervention / Treatment
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* Behavioral: nutritional counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be included in the program ATDOM, 65 years or more, have an MNA between 17 and 23.5 points, have a caregiver. Exclusion Criteria: have a MNA outside the range of 17 to 23.5 points, conducting enteral feeding have severe dysphagia, have any serious illness that progresses to malnutrition, take vitamin supplements and / or dietary supplements.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional counseling<br>Supervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice | Behavioral: nutritional counseling<br>* Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses<br>|
| No Intervention: Not nutritional counseling<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Nutritional status by : Mini Nutritional Assessment questionnaire (MNA validated questionaire), diet (validated questionaire), anthropometric measurements (weight, height, body circumferences) and biochemicals parametres (Serum albumin and serum prealbumin by chemiluminescence; serum transferrin by immunoturbidimetric; hemoglobin and lymphocyte count by coulter, serum iron by colorimetric using ferrozine, and serum ferritin by radioimmunoassay. | at 0, 6 and 12 moths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional status, Dependent patients, Nutritional educational intervention, Caregivers, Clinical assay