Clinical trial NCT02345759: Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease
Official title: Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychological Characteristics Involved in Dietary Compliance
Keywords: CKD patients
protein-restricted diets
compliance
psychological aspects
Lead sponsor: Anemia Working Group Romania
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive adult patients, with stage 4-5ND CKD (estimated glomerular filtration by MDRD formula of less than 30 mL/min per year) included in the dietary intervention program of "Dr Carol Davila" Teaching Hospital of Nephrology coming for the scheduled visits between January the 1st and June the 30th, 2014 will be considered eligible.

Those who will sign the informed consent will be included in the study; the specially-designed questionnaire will be administered. Simultaneously, their routine assesment, including the dietary compliance, manifestations of CKD and the nutritional status will be performed, as recommended by the Romanian Best Practice Guidelines for CKD \[28\].

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Compliance to the protein-restricted diet
timeFrame: 12 months
Secondary outcomes:
measure: Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline
timeFrame: 12 months
measure: Psychological parameter - self-efficacy score
timeFrame: 12 months
measure: Nitrogen balance (Serum urea level)
timeFrame: 12 months
measure: Metabolic acidosis (Serum bicarbonate level)
timeFrame: 12 months
measure: Calcium-phosphorus metabolism abnormalities (Serum calcium)
timeFrame: 12 months
measure: Calcium-phosphorus metabolism abnormalities (Serum phosphates level)
timeFrame: 12 months
measure: Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire)
timeFrame: 12 months
measure: Mental status - vitality index
timeFrame: 12 months
measure: Psychological parameter -mental score
timeFrame: 12 months
Other outcomes:
measure: Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol)
timeFrame: 12 months
Locations:
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Nefrologie "Dr Carol Davila"
Study officials:
affiliation: Spitalul Clinic de Nefrologie "Dr Carol Davila"
name: Gabriel Mircescu, Professor of Nephrology
role: STUDY_CHAIR
affiliation: Spitalul Clinic de Nefrologie "Dr Carol Davila"
name: Liliana Garneata, MD, PhD
role: STUDY_DIRECTOR
affiliation: Spitalul Clinic de Nefrologie "Dr Carol Davila"
name: Cristina Drugau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Health Care Systems Romania
name: Evy Dehelean, Psychologist
role: PRINCIPAL_INVESTIGATOR
References: