- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02345759
Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease (KetoPsy)
Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Liliana Garneata, MD, PhD
- Phone Number: +40722619358
- Email: lilianagarna@yahoo.com
Study Contact Backup
- Name: Cristina Drugau
- Email: cristina.drugau@yahoo.com
Study Locations
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-
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Bucuresti, Romania, 010731
- Recruiting
- Spitalul Clinic de Nefrologie "Dr Carol Davila"
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Contact:
- Liliana Garneata, MD, PhD
- Phone Number: 0722619358
- Email: lilianagarna@yahoo.com
-
Contact:
- Cristina Drugau, MD
- Email: cristina.drugau@yahoo.com
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Sub-Investigator:
- Cristina Drugau, MD
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Sub-Investigator:
- Gabriel Stefan, MD
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Sub-Investigator:
- Paula Larisa Luca, MD
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Sub-Investigator:
- Alexandra Stancu, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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].
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Keto-diet group
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.
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Conventional LPD group
0.6 g/kg per day, including high biological value proteins
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
Time Frame: 12 months
|
The decline in glomerular filtration rate (GFR)
|
12 months
|
Psychological parameter - self-efficacy score
Time Frame: 12 months
|
Self-efficacy score derives from the self-efficacy scale.
|
12 months
|
Nitrogen balance (Serum urea level)
Time Frame: 12 months
|
Serum urea level
|
12 months
|
Metabolic acidosis (Serum bicarbonate level)
Time Frame: 12 months
|
Serum bicarbonate level
|
12 months
|
Calcium-phosphorus metabolism abnormalities (Serum calcium)
Time Frame: 12 months
|
Serum calcium
|
12 months
|
Calcium-phosphorus metabolism abnormalities (Serum phosphates level)
Time Frame: 12 months
|
Serum phosphates level
|
12 months
|
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.
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12 months
|
Mental status - vitality index
Time Frame: 12 months
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Vitality score derived from mental component of SF-36
|
12 months
|
Psychological parameter -mental score
Time Frame: 12 months
|
The mental score looks at depression.
Psychological difficulties interfere with the initiation of compliance behaviours.
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12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWG 5/2014
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