Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change on nutritional status measured with Global Subjective Assesment
研究概览
简要总结
To assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months
详细描述
Randomized clinical trial with blinded evaluators. (The evaluators will not know the group the patients are assigned. Blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). Patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. Patients will be divided in two groups randomly:
In one arm will be held a double intervention:
- A structured educational intervention oriented to the patient and primary caregiver, with respect to dietary habits, highly energetic and healthy food, the frequency and manner of eating, exercise and programming breaks.
- supplementation with dietary supplements, distinguishing one type of product or another, depending on whether the subject to study: diabetes and or kidney failure.
In the other arm of the study was carried out regular interventions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with the diagnosis of heart failure: who inadvertently lost at least 5% of their "dry weight" in the last six months and / or moderately or severely malnourished according to the GSA and / or at risk or malnourished according to Mini Nutritional Assessment.
- •Willing to participate by accepting and signing an informed consent.
- •On treatment with inhibitors of angiotensin converting enzyme (ACE) inhibitors and / or antagonists of angiotensin II receptors (ARBs) and / or beta blockers.
排除标准
- •Concurrent active cancer diagnosed.
- •Previous history Dementia or severe cognitive impairment.
- •Participation in another clinical trial simultaneously.
- •Social or health condition that makes the patient impossible to follow the treatment.
研究组 & 干预措施
educational intervention and supplements
structured educational intervention and dietary supplements
干预措施: Hypercaloric beverages (Dietary Supplement)
educational intervention and supplements
structured educational intervention and dietary supplements
干预措施: educational structured counseling (Other)
usual interventions
Usual treatment without nutritional supplements or structured assessment
干预措施: standard treatment (Other)
结局指标
主要结局
Change on nutritional status measured with Global Subjective Assesment
时间窗: At inclusion , months 3 and 9
次要结局
- Number of readmission.(at month 12)
- Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement(At inclusion , months 3 and 9)
- Change on meters walked in six minutes (functional capacity), after the intervention(At inclusion , months 3 and 9)
研究者
Luis Guerra
Nurse
Hospital General Universitario Gregorio Marañon