Nutritional Education for Dependant Patients (atdom_nut)
|ClinicalTrials.gov Identifier: NCT01360775|
Recruitment Status : Unknown
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was: Recruiting
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Risk of Malnutrition||Behavioral: nutritional counseling||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention of Nutritional Education Addressed to Carers of Dependant Patients|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||June 2012|
Experimental: nutritional counseling
Supervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice
Behavioral: nutritional counseling
Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses
|No Intervention: Not nutritional counseling|
- Nutritional status [ Time Frame: at 0, 6 and 12 moths ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360775
|Primary Care Centers||Recruiting|
|Tarragona and Reus, Tarragona, Spain|
|Contact: Arija +34 977 778515 email@example.com|