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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 24, 2011
Last Updated Date	May 25, 2011
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 25, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01360775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Nutritional Education for Dependant Patients
Official Title ^ICMJE	Intervention of Nutritional Education Addressed to Carers of Dependant Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Risk of Malnutrition
Intervention ^ICMJE	Behavioral: nutritional counseling Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses
Study Arm (s)	Experimental: nutritional counseling Supervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice Intervention: Behavioral: nutritional counseling No Intervention: Not nutritional counseling
Publications *	Arija V, Martín N, Canela T, Anguera C, Castelao AI, García-Barco M, García-Campo A, González-Bravo AI, Lucena C, Martínez T, Fernández-Barrés 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	200
Completion Date	Not Provided
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01360775
Other Study ID Numbers ^ICMJE	PI09/90340
Has Data Monitoring Committee	Not Provided
Responsible Party	Victoria Arija, Jordi Gol i Gurina Foundation
Study Sponsor ^ICMJE	Jordi Gol i Gurina Foundation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Jordi Gol i Gurina Foundation
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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