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临床试验/NCT01360775
NCT01360775Unknown1 期

Intervention of Nutritional Education Addressed to Carers of Dependant Patients

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
200
试验地点
1
主要终点
Nutritional status

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be included in the program ATDOM,
  • 65 years or more,
  • have an MNA between 17 and 23.5 points,
  • have a caregiver.

排除标准

  • 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.

结局指标

主要结局

Nutritional status

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other

研究点 (1)

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