Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease
- Conditions
- Psychological Characteristics Involved in Dietary Compliance
- Registration Number
- NCT02345759
- Lead Sponsor
- Anemia Working Group Romania
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance to the protein-restricted diet 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.
- Secondary Outcome Measures
Name Time Method Nitrogen balance (Serum urea level) 12 months Serum urea level
Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline 12 months The decline in glomerular filtration rate (GFR)
Psychological parameter - self-efficacy score 12 months Self-efficacy score derives from the self-efficacy scale.
Metabolic acidosis (Serum bicarbonate level) 12 months Serum bicarbonate level
Calcium-phosphorus metabolism abnormalities (Serum calcium) 12 months Serum calcium
Calcium-phosphorus metabolism abnormalities (Serum phosphates level) 12 months Serum phosphates level
Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire) 12 months Sub-scores derived from illness perception questionnaire: the higher this score, the worse is patient's perception on the disease.
Mental status - vitality index 12 months Vitality score derived from mental component of SF-36
Psychological parameter -mental score 12 months The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours.
Trial Locations
- Locations (1)
Spitalul Clinic de Nefrologie "Dr Carol Davila"
🇷🇴Bucuresti, Romania