Nutritional Education for Dependant Patients (atdom_nut)
Intervention of Nutritional Education Addressed to Carers of Dependant Patients
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Tarragona
-
Tarragona and Reus, Tarragona, Spanje
- Werving
- Primary Care Centers
-
Contact:
- Arija
- Telefoonnummer: +34 977 778515
- E-mail: victoria.arija@urv.cat
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: nutritional counseling
Supervision and monitoring of nutritional status of patients in the home care program, after making nutritional advice
|
Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses
|
|
Geen tussenkomst: Not nutritional counseling
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Nutritional status
Tijdsspanne: 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.
|
at 0, 6 and 12 moths
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PI09/90340
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .