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Trial record 89 of 359 for:    transthyretin

Nutritional Education for Dependant Patients (atdom_nut)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360775
Recruitment Status : Unknown
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
Information provided by:
Jordi Gol i Gurina Foundation

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.

Condition or disease Intervention/treatment Phase
Risk of Malnutrition Behavioral: nutritional counseling Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention of Nutritional Education Addressed to Carers of Dependant Patients
Study Start Date : January 2010
Estimated Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Nutritional status [ Time Frame: at 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360775

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Primary Care Centers Recruiting
Tarragona and Reus, Tarragona, Spain
Contact: Arija    +34 977 778515   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Victoria Arija, Jordi Gol i Gurina Foundation Identifier: NCT01360775     History of Changes
Other Study ID Numbers: PI09/90340
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: October 2009

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

Additional relevant MeSH terms:
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Nutrition Disorders