Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

BACKGROUND Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions.The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. METHODS/DESIGN Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0-6-12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin.Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient's nutritional status using the MNA test, diet, anthropometry, and biochemical parameters.Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention.The SPSS/PC program will be used for statistical analysis. DISCUSSION The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers' education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. TRIAL REGISTRATION NUMBER Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775.