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

August 4, 2018 updated by: Anemia Working Group Romania

Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease

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.

Study Overview

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

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bucuresti, Romania, 010731
        • Recruiting
        • Spitalul Clinic de Nefrologie "Dr Carol Davila"
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Cristina Drugau, MD
        • Sub-Investigator:
          • Gabriel Stefan, MD
        • Sub-Investigator:
          • Paula Larisa Luca, MD
        • Sub-Investigator:
          • Alexandra Stancu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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].

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

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.
12 months
Mental status - vitality index
Time Frame: 12 months
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.
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 23, 2014

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 4, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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