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

NCT02345759 | Unknown DMC

• 1 other identifier: AWG 5/2014
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Characteristics Involved in Dietary Compliance

Keywords

CKD patients; protein-restricted diets; compliance; psychological aspects

Outcome Measures

Primary Outcomes (1)

• Compliance to the protein-restricted diet

  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 Outcomes (9)

• Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline

  12 months

• Psychological parameter - self-efficacy score

  12 months

• Nitrogen balance (Serum urea level)

  12 months

• Metabolic acidosis (Serum bicarbonate level)

  12 months

• Calcium-phosphorus metabolism abnormalities (Serum calcium)

  12 months

Other Outcomes (1)

• Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol)

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \[28\].

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anemia Working Group Romania: lead

Study Sites (1)

Spitalul Clinic de Nefrologie "Dr Carol Davila"

Bucharest, 010731, Romania

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gabriel Mircescu, Professor of Nephrology

  Spitalul Clinic de Nefrologie "Dr Carol Davila"

  STUDY CHAIR

• Liliana Garneata, MD, PhD

  Spitalul Clinic de Nefrologie "Dr Carol Davila"

  STUDY DIRECTOR

• Cristina Drugau, MD

  Spitalul Clinic de Nefrologie "Dr Carol Davila"

  PRINCIPAL INVESTIGATOR

• Evy Dehelean, Psychologist

  International Health Care Systems Romania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliana Garneata, MD, PhD

CONTACT

+40722619358; lilianagarna@yahoo.com

Cristina Drugau

CONTACT

cristina.drugau@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2014
• First Posted: January 26, 2015
• Study Start: January 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

RO (1)