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Nutritional Education for Dependant Patients

Phase 1
Conditions
Risk of Malnutrition
Interventions
Behavioral: nutritional counseling
Registration Number
NCT01360775
Lead Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
nutritional counselingnutritional counselingSupervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice
Primary Outcome Measures
NameTimeMethod
Nutritional statusat 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Primary Care Centers

🇪🇸

Tarragona and Reus, Tarragona, Spain

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