NCT01360775

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

May 26, 2011

Status Verified

October 1, 2009

Enrollment Period

2.4 years

First QC Date

May 24, 2011

Last Update Submit

May 25, 2011

Conditions

Risk of Malnutrition

Keywords

Nutritional statusDependent patientsNutritional educational interventionCaregiversClinical assay

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    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.

    at 0, 6 and 12 moths

Study Arms (2)

nutritional counseling

EXPERIMENTAL

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

Behavioral: nutritional counseling

Not nutritional counseling

NO INTERVENTION

Interventions

nutritional counselingBEHAVIORAL

Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses

nutritional counseling

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be included in the program ATDOM,
  • years or more,
  • have an MNA between 17 and 23.5 points,
  • have a caregiver.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Centers

Tarragona and Reus, Tarragona, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28273591DERIVED

  • 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.

    PMID: 22625878DERIVED

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Last Updated

May 26, 2011

Record last verified: 2009-10

Locations

ES(1)