Psychological Characteristics Involved in Dietary Compliance
Conditions
Keywords
CKD patients, protein-restricted diets, compliance, psychological aspects
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.
Interventions
None listed
Sponsors
Anemia Working Group Romania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Calcium-phosphorus metabolism abnormalities (Serum phosphates level) | 12 months | Serum phosphates 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. |
| Nitrogen balance (Serum urea level) | 12 months | Serum urea level |
| Calcium-phosphorus metabolism abnormalities (Serum calcium) | 12 months | Serum calcium |
| 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. |
| Metabolic acidosis (Serum bicarbonate level) | 12 months | Serum bicarbonate level |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol) | 12 months | Parameters of nutritional status are predefined as safety parameters. Subjective Global Assessment anthropometric markers, and biochemical parameters |
Countries
Romania
Contacts
Primary ContactLiliana Garneata, MD, PhD
Backup ContactCristina Drugau
Outcome results
None listed