Nutritional Education for Dependant Patients (atdom_nut)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase: Unknown; Phase 1

Conditions: Risk of Malnutrition

Treatments: Behavioral: nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01360775

PI09/90340

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

nutritional counseling

Experimental group

Description:

Supervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice

Treatment:

Behavioral: nutritional counseling

Not nutritional counseling

No Intervention group