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Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease (KetoPsy)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Anemia Working Group Romania
Sponsor:
Information provided by (Responsible Party):
Anemia Working Group Romania
ClinicalTrials.gov Identifier:
NCT02345759
First received: August 23, 2014
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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.

Condition
Psychological Characteristics Involved in Dietary Compliance

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Anemia Working Group Romania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
Conventional LPD group
0.6 g/kg per day, including high biological value proteins

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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].

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02345759

Contacts
Contact: Liliana Garneata, MD, PhD +40722619358 lilianagarna@yahoo.com
Contact: Cristina Drugau cristina.drugau@yahoo.com

Locations
Romania
Spitalul Clinic de Nefrologie "Dr Carol Davila" Recruiting
Bucuresti, Romania, 010731
Contact: Liliana Garneata, MD, PhD    0722619358    lilianagarna@yahoo.com   
Contact: Cristina Drugau, MD       cristina.drugau@yahoo.com   
Sub-Investigator: Cristina Drugau, MD         
Sub-Investigator: Gabriel Stefan, MD         
Sub-Investigator: Paula Larisa Luca, MD         
Sub-Investigator: Alexandra Stancu, MD         
Sponsors and Collaborators
Anemia Working Group Romania
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
  More Information

Responsible Party: Anemia Working Group Romania
ClinicalTrials.gov Identifier: NCT02345759     History of Changes
Other Study ID Numbers: AWG 5/2014
Study First Received: August 23, 2014
Last Updated: January 24, 2017

Keywords provided by Anemia Working Group Romania:
CKD patients
protein-restricted diets
compliance
psychological aspects

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 27, 2017