Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease (KetoPsy)
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|ClinicalTrials.gov Identifier: NCT02345759|
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : January 25, 2017
|Condition or disease|
|Psychological Characteristics Involved in Dietary Compliance|
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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
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
0.6 g/kg per day, including high biological value proteins
- Compliance to the protein-restricted diet [ Time Frame: 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.
- Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline [ Time Frame: 12 months ]The decline in glomerular filtration rate (GFR)
- Psychological parameter - self-efficacy score [ Time Frame: 12 months ]Self-efficacy score derives from the self-efficacy scale.
- Nitrogen balance (Serum urea level) [ Time Frame: 12 months ]Serum urea level
- Metabolic acidosis (Serum bicarbonate level) [ Time Frame: 12 months ]Serum bicarbonate level
- Calcium-phosphorus metabolism abnormalities (Serum calcium) [ Time Frame: 12 months ]Serum calcium
- Calcium-phosphorus metabolism abnormalities (Serum phosphates level) [ Time Frame: 12 months ]Serum phosphates level
- Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire) [ Time Frame: 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 [ Time Frame: 12 months ]Vitality score derived from mental component of SF-36
- Psychological parameter -mental score [ Time Frame: 12 months ]The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours.
- Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol) [ Time Frame: 12 months ]Parameters of nutritional status are predefined as safety parameters. Subjective Global Assessment anthropometric markers, and biochemical parameters
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345759
|Contact: Liliana Garneata, MD, PhDfirstname.lastname@example.org|
|Contact: Cristina Drugauemail@example.com|
|Spitalul Clinic de Nefrologie "Dr Carol Davila"||Recruiting|
|Bucuresti, Romania, 010731|
|Contact: Liliana Garneata, MD, PhD 0722619358 firstname.lastname@example.org|
|Contact: Cristina Drugau, MD email@example.com|
|Sub-Investigator: Cristina Drugau, MD|
|Sub-Investigator: Gabriel Stefan, MD|
|Sub-Investigator: Paula Larisa Luca, MD|
|Sub-Investigator: Alexandra Stancu, MD|
|Study Chair:||Gabriel Mircescu, Professor of Nephrology||Spitalul Clinic de Nefrologie "Dr Carol Davila"|
|Study Director:||Liliana Garneata, MD, PhD||Spitalul Clinic de Nefrologie "Dr Carol Davila"|
|Principal Investigator:||Cristina Drugau, MD||Spitalul Clinic de Nefrologie "Dr Carol Davila"|
|Principal Investigator:||Evy Dehelean, Psychologist||International Health Care Systems Romania|