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Nutritional Education for Dependant Patients (atdom_nut)

Primary Purpose

Risk of Malnutrition

Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
nutritional counseling
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Risk of Malnutrition focused on measuring Nutritional status, Dependent patients, Nutritional educational intervention, Caregivers, Clinical assay

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Primary Care CentersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

nutritional counseling

Not nutritional counseling

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2011
Last Updated
May 25, 2011
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT01360775
Brief Title
Nutritional Education for Dependant Patients
Acronym
atdom_nut
Official Title
Intervention of Nutritional Education Addressed to Carers of Dependant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk of Malnutrition
Keywords
Nutritional status, Dependent patients, Nutritional educational intervention, Caregivers, Clinical assay

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nutritional counseling
Arm Type
Experimental
Arm Description
Supervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice
Arm Title
Not nutritional counseling
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
nutritional counseling
Intervention Description
Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses
Primary Outcome Measure Information:
Title
Nutritional status
Description
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.
Time Frame
at 0, 6 and 12 moths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Primary Care Centers
City
Tarragona and Reus
State/Province
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arija
Phone
+34 977 778515
Email
victoria.arija@urv.cat

12. IPD Sharing Statement

Citations:
PubMed Identifier
28273591
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.
Results Reference
derived
PubMed Identifier
22625878
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.
Results Reference
derived

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Nutritional Education for Dependant Patients

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