Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Compliance to the protein-restricted diet
研究概览
简要总结
Dietary management of CKD patients proved important to postpone dialysis. Long-term compliance to protein-restricted diets was discussed. Psychological aspects involved in certain dietary behaviour have never been studied.
详细描述
The interest in dietary management resurged, since the high prevalence of revealed a major impact not only on morbidity, mortality, social activities and patients' quality of life, but also on health budget.
Although protein-restricted diets are used for more than a century in patients with advanced Chronic Kidney Disease (CKD), their efficacy and safety is still debatable. Enough evidence has being accumulated on their role in postponing dialysis initiation in compliant patients. Consequently, the long-term compliance to the diet is discussed. Psychological aspects of compliant patients are certainly involved. Identification of certain psychological predictors of dietary compliance could help to select the patients who are more likely to be compliant and therefore to benefit from such an intervention. Moreover, short-term or long-term psychological intervention addressing these factors could increase patient long-term compliance.
Accordingly, we are aiming to evaluate psychological characteristics of Chronic Kidney Disease patients in relation with their compliance to protein-restricted regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •stage 4+ CKD
- •good nutritional status (Subjective Global Assessment score A/B and serum albumin ≥3.5 g/dL)
- •declared potentially good compliance with a low protein diet and agreed to follow the monitoring schedule are considered for the program
排除标准
- •poorly controlled arterial blood pressure (≥145/85 mm Hg)
- •uncontrolled diabetes mellitus
- •other relevant comorbidities (heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
- •uremic complications (pericarditis, polyneuropathy)
- •feeding inability (anorexia, nausea)
结局指标
主要结局
Compliance to the protein-restricted diet
时间窗: 12 months
The compliance to the diet is appreciated to be good if both the achieved protein intake and the achieved energy is in the range of ±10% of the recommended values.
次要结局
- Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline(12 months)
- Psychological parameter - self-efficacy score(12 months)
- Nitrogen balance (Serum urea level)(12 months)
- Metabolic acidosis (Serum bicarbonate level)(12 months)
- Calcium-phosphorus metabolism abnormalities (Serum calcium)(12 months)
- Calcium-phosphorus metabolism abnormalities (Serum phosphates level)(12 months)
- Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire)(12 months)
- Mental status - vitality index(12 months)
- Psychological parameter -mental score(12 months)