Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02345759
Status:
UNKNOWN
Last Update Posted:
2018-08-07
First Post:
2014-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-04', 'studyFirstSubmitDate': '2014-08-23', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety parameters (Subjective Global Assessment, anthropometric markers, biochemical parameters, and serum total cholesterol)', 'timeFrame': '12 months', 'description': 'Parameters of nutritional status are predefined as safety parameters. Subjective Global Assessment anthropometric markers, and biochemical parameters'}], 'primaryOutcomes': [{'measure': 'Compliance to the protein-restricted diet', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Parameters related to renal function (The decline in glomerular filtration rate (GFR) GFR decline', 'timeFrame': '12 months', 'description': 'The decline in glomerular filtration rate (GFR)'}, {'measure': 'Psychological parameter - self-efficacy score', 'timeFrame': '12 months', 'description': 'Self-efficacy score derives from the self-efficacy scale.'}, {'measure': 'Nitrogen balance (Serum urea level)', 'timeFrame': '12 months', 'description': 'Serum urea level'}, {'measure': 'Metabolic acidosis (Serum bicarbonate level)', 'timeFrame': '12 months', 'description': 'Serum bicarbonate level'}, {'measure': 'Calcium-phosphorus metabolism abnormalities (Serum calcium)', 'timeFrame': '12 months', 'description': 'Serum calcium'}, {'measure': 'Calcium-phosphorus metabolism abnormalities (Serum phosphates level)', 'timeFrame': '12 months', 'description': 'Serum phosphates level'}, {'measure': 'Psychological parameter - illness perception (Sub-scores derived from illness perception questionnaire)', 'timeFrame': '12 months', 'description': "Sub-scores derived from illness perception questionnaire: the higher this score, the worse is patient's perception on the disease."}, {'measure': 'Mental status - vitality index', 'timeFrame': '12 months', 'description': 'Vitality score derived from mental component of SF-36'}, {'measure': 'Psychological parameter -mental score', 'timeFrame': '12 months', 'description': 'The mental score looks at depression. Psychological difficulties interfere with the initiation of compliance behaviours.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CKD patients', 'protein-restricted diets', 'compliance', 'psychological aspects'], 'conditions': ['Psychological Characteristics Involved in Dietary Compliance']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAlthough 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.\n\nAccordingly, we are aiming to evaluate psychological characteristics of Chronic Kidney Disease patients in relation with their compliance to protein-restricted regimens."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThose 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\\].', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* stage 4+ CKD\n* good nutritional status (Subjective Global Assessment score A/B and serum albumin ≥3.5 g/dL)\n* declared potentially good compliance with a low protein diet and agreed to follow the monitoring schedule are considered for the program\n\nExclusion Criteria:\n\n* poorly controlled arterial blood pressure (≥145/85 mm Hg)\n* uncontrolled diabetes mellitus\n* other relevant comorbidities (heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)\n* uremic complications (pericarditis, polyneuropathy)\n* feeding inability (anorexia, nausea)'}, 'identificationModule': {'nctId': 'NCT02345759', 'acronym': 'KetoPsy', 'briefTitle': 'Psychological Aspects and Patients Compliance to Restricted-protein Regimens in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Anemia Working Group Romania'}, 'officialTitle': 'Psychological Aspects Related to Compliance of Patients on Restricted-protein Regimens in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'AWG 5/2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Keto-diet group', 'description': '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.'}, {'label': 'Conventional LPD group', 'description': '0.6 g/kg per day, including high biological value proteins'}]}, 'contactsLocationsModule': {'locations': [{'zip': '010731', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Liliana Garneata, MD, PhD', 'role': 'CONTACT', 'email': 'lilianagarna@yahoo.com', 'phone': '0722619358'}, {'name': 'Cristina Drugau, MD', 'role': 'CONTACT', 'email': 'cristina.drugau@yahoo.com'}, {'name': 'Cristina Drugau, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gabriel Stefan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paula Larisa Luca, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Stancu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Spitalul Clinic de Nefrologie "Dr Carol Davila"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'centralContacts': [{'name': 'Liliana Garneata, MD, PhD', 'role': 'CONTACT', 'email': 'lilianagarna@yahoo.com', 'phone': '+40722619358'}, {'name': 'Cristina Drugau', 'role': 'CONTACT', 'email': 'cristina.drugau@yahoo.com'}], 'overallOfficials': [{'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': 'Spitalul Clinic de Nefrologie "Dr Carol Davila"'}, {'name': 'Evy Dehelean, Psychologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Health Care Systems Romania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anemia Working Group Romania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}