Nutritional Education for Dependant Patients (atdom_nut)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01360775
First received: May 24, 2011
Last updated: May 25, 2011
Last verified: October 2009
  Purpose

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 Intervention Phase
Risk of Malnutrition
Behavioral: nutritional counseling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intervention of Nutritional Education Addressed to Carers of Dependant Patients

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Nutritional status [ Time Frame: at 0, 6 and 12 moths ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360775

Locations
Spain
Primary Care Centers Recruiting
Tarragona and Reus, Tarragona, Spain
Contact: Arija    +34 977 778515    victoria.arija@urv.cat   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victoria Arija, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01360775     History of Changes
Other Study ID Numbers: PI09/90340
Study First Received: May 24, 2011
Last Updated: May 25, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Nutritional status
Dependent patients
Nutritional educational intervention
Caregivers
Clinical assay

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 28, 2014