Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease

Conditions
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Psychological Characteristics Involved in Dietary Compliance

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Keto-diet group<br>Vegetarian very low protein regimen (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day. | |
| Conventional LPD group<br>0.6 g/kg per day, including high biological value proteins | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to the protein-restricted diet | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline | The decline in glomerular filtration rate (GFR) | 12 months | 
| Psychological parameter - self-efficacy score | Self-efficacy score derives from the self-efficacy scale. | 12 months | 
| Nitrogen balance (Serum urea level) | Serum urea level | 12 months | 
| Metabolic acidosis (Serum bicarbonate level) | Serum bicarbonate level | 12 months | 
| Calcium-phosphorus metabolism abnormalities (Serum calcium) | Serum calcium | 12 months | 
| Calcium-phosphorus metabolism abnormalities (Serum phosphates level) | Serum phosphates level | 12 months | 
| Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire) | Sub-scores derived from illness perception questionnaire: the higher this score, the worse is patient's perception on the disease. | 12 months | 
| Mental status - vitality index | Vitality score derived from mental component of SF-36 | 12 months | 
| Psychological parameter -mental score | The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD patients, protein-restricted diets, compliance, psychological aspects