Nutritional Education for Dependant Patients (atdom_nut)
Recruitment status was Recruiting
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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 |
- 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 |
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| Spain | |
| Primary Care Centers | Recruiting |
| Tarragona and Reus, Tarragona, Spain | |
| Contact: Arija +34 977 778515 victoria.arija@urv.cat | |
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 June 17, 2013