Risk of Malnutrition Clinical Trial
— atdom_nutOfficial title:
Intervention of Nutritional Education Addressed to Carers of Dependant Patients
| NCT number | NCT01360775 |
| Other study ID # | PI09/90340 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 1 |
| First received | May 24, 2011 |
| Last updated | May 25, 2011 |
| Start date | January 2010 |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Primary Care Centers | Tarragona and Reus | Tarragona |
| Lead Sponsor | Collaborator |
|---|---|
| Jordi Gol i Gurina Foundation |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | at 0, 6 and 12 moths | No |