Clinical trial NCT01360775: Nutritional Education for Dependant Patients
Official title: Intervention of Nutritional Education Addressed to Carers of Dependant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Risk of Malnutrition
Keywords: Nutritional status
Dependent patients
Nutritional educational intervention
Caregivers
Clinical assay
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nutritional status
timeFrame: at 0, 6 and 12 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Tarragona and Reus
country: Spain
facility: Primary Care Centers
state: Tarragona
Study officials:
References:
citation: Fernandez-Barres S, Garcia-Barco M, Basora J, Martinez T, Pedret R, Arija V; Project ATDOM-NUT group. The efficacy of a nutrition education intervention to prevent risk of malnutrition for dependent elderly patients receiving Home Care: A randomized controlled trial. Int J Nurs Stud. 2017 May;70:131-141. doi: 10.1016/j.ijnurstu.2017.02.020. Epub 2017 Feb 23.
citation: Arija V, Martin N, Canela T, Anguera C, Castelao AI, Garcia-Barco M, Garcia-Campo A, Gonzalez-Bravo AI, Lucena C, Martinez T, Fernandez-Barres S, Pedret R, Badia W, Basora J. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial. BMC Public Health. 2012 May 24;12:373. doi: 10.1186/1471-2458-12-373.