[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557327":3},{"organization":4,"outcomesModule":7,"designInfo":134,"detailedDescription":141,"studyPopulation":133,"armGroups":142,"interventions":154,"overallOfficials":133,"centralContacts":166,"locations":133,"responsibleParty":172,"collaborators":133,"id":176,"slug":133,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":133,"eligibilityCriteria":181,"healthyVolunteers":177,"sex":182,"minAge":183,"maxAge":133,"enrollmentInfo":184,"targetDuration":133,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":196,"whyStopped":133,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":133},{"fullName":5,"class":6},"Universitat de Lleida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":133},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of peritonitis","It is calculated as the number of episodes of peritonitis per patient and year at risk.","1 year after educational intervention.",[14,18,21,24,27,30,32,34,37,40,43,45,47,49,51,53,56,59,62,65,68,71,74,76,79,83,86,89,92,95,98,101,104,107,110,113,115,117,120,123,125,127,130],{"measure":15,"description":16,"timeFrame":17},"Age","In years","Day 1 of peritoneal technique training.",{"measure":19,"description":20,"timeFrame":17},"Gender","Male or female",{"measure":22,"description":23,"timeFrame":17},"Language barrier","Yes or not",{"measure":25,"description":26,"timeFrame":17},"Marital status","Single, married, coupled, separated - divorced, widowed",{"measure":28,"description":29,"timeFrame":17},"Educational level","Not finished primary studies, primary schools, secondary, middle\u002Fhigher grade cycle, high school, university studies, doctorate",{"measure":31,"description":23,"timeFrame":17},"Caregiver disposition",{"measure":33,"description":23,"timeFrame":17},"Drinking water supply",{"measure":35,"description":36,"timeFrame":17},"Weight","In kilograms",{"measure":38,"description":39,"timeFrame":17},"Height","In meters",{"measure":41,"description":42,"timeFrame":17},"Body Mass Index (BMI)","BMI= Current weight (kg) ÷ height (m) x height (m)= kg\u002Fm2. Low weight: Less than 18.4 Normal weight: 18.5 to 24.9 Overweight: 25 to 29.9 Grade I Obesity: 30 to 34.9 Grade II Obesity: 35 to 39.9 Grade III Obesity: Equal to or greater than 40.",{"measure":44,"description":23,"timeFrame":17},"Diabetes",{"measure":46,"description":23,"timeFrame":17},"Cardiovascular disease",{"measure":48,"description":23,"timeFrame":17},"Cerebrovascular disease",{"measure":50,"description":23,"timeFrame":17},"Hypertension",{"measure":52,"description":23,"timeFrame":17},"Cancer",{"measure":54,"description":55,"timeFrame":17},"The primary cause of kidney disease","Glomerular disease, tubulointerstitial disease, diabetes mellitus, hypertension, other systemic diseases, familial\u002Fhereditary nephropathy, various renal disorders",{"measure":57,"description":58,"timeFrame":17},"Barthel index","Scores of 100 imply total independence. Scores between 100 and 60 indicate the existence of a slight dependency or need for help, between 55 and 40 a moderate dependency, from 35 to 20 we would speak of severe dependency and scores below 20 points would indicate that the subject has a total dependence",{"measure":60,"description":61,"timeFrame":17},"Lawton and Brody scale","The 8 points indicate total independence to carry out the instrumental activities of daily life.- A lower result indicates functional deterioration.",{"measure":63,"description":64,"timeFrame":17},"Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D)","They are coded as 1 if the response option is \"I have no problems\"; with a 2 if the response option is \"some or moderate problems\"; and with a 3 if the answer option is \"many problems.\" In such a way that the higher the value reflected, the worse the assessment that the subject makes of his or her state.",{"measure":66,"description":67,"timeFrame":17},"Cognitive impairment -PFEIFFER Test","From 0 to 2 errors: The patient is considered to have no cognitive impairment. 3 to 4 errors: The patient is considered to have mild cognitive impairment. From 5 to 7 errors: The patient is considered to have moderate cognitive impairment",{"measure":69,"description":70,"timeFrame":17},"Fragility detection - Q-Scale FRAIL","Between 1-2 affirmative answers: pre-fragile. \\>2 fragile",{"measure":72,"description":73,"timeFrame":17},"The origin before arriving at peritoneal dialysis","Pre-dialysis, hemodialysis, transplantation, cardiorenal syndrome",{"measure":75,"description":23,"timeFrame":17},"Residual renal function",{"measure":77,"description":78,"timeFrame":17},"Type of peritoneal catheter","Self-positioning catheter\u002FTenckhoff straight",{"measure":80,"description":81,"timeFrame":82},"Hemoglobin","12.0 - 16.0 gr\u002Fdl","First month of the start of the technique at home.",{"measure":84,"description":85,"timeFrame":82},"Serum albumin","3.4 - 5.2 g\u002FdL",{"measure":87,"description":88,"timeFrame":82},"Serum potassium","3.50 - 5.50 mmol\u002FL",{"measure":90,"description":91,"timeFrame":82},"Serum sodium","135.0 - 150.0 mmol\u002FL",{"measure":93,"description":94,"timeFrame":82},"Serum bicarbonate","23.0 - 27.0 mmol\u002FL",{"measure":96,"description":97,"timeFrame":82},"Serum calcium","8.80 - 10.60 mg\u002FdL",{"measure":99,"description":100,"timeFrame":82},"Serum phosphorus","2.70 - 4.50 mg\u002FdL",{"measure":102,"description":103,"timeFrame":82},"Blood urea nitrogen","10 - 50 mg\u002FdL",{"measure":105,"description":106,"timeFrame":82},"Serum creatinine","0.50 - 0.90 mg\u002FdL",{"measure":108,"description":23,"timeFrame":109},"Peritonitis","Follow-up during the first year after educational intervention.",{"measure":111,"description":112,"timeFrame":109},"Time to first peritonitis","In months without peritonitis",{"measure":114,"description":23,"timeFrame":109},"Orifice infection",{"measure":116,"description":23,"timeFrame":109},"Peritoneal orifice tunnelitis",{"measure":118,"description":119,"timeFrame":109},"Result of peritoneal fluid culture","positive, negative",{"measure":121,"description":122,"timeFrame":109},"Type of peritoneal infection","Germ, fungus, biofilm",{"measure":124,"description":23,"timeFrame":109},"Reinfection",{"measure":126,"description":23,"timeFrame":109},"Relapse",{"measure":128,"description":129,"timeFrame":109},"Complicated peritonitis","change of technique\u002Fdeath",{"measure":131,"description":132,"timeFrame":109},"Antibiotic administered","Type of antibiotic administered, the dosage.",null,{"allocation":135,"interventionModel":136,"interventionModelDescription":137,"primaryPurpose":138,"observationalModel":133,"timePerspective":133,"maskingInfo":139},"NON_RANDOMIZED","PARALLEL","A retrospective control group with patients starting DP before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study.","PREVENTION",{"masking":140,"maskingDescription":133,"whoMasked":133},"NONE","Peritoneal infections (PI) have been a very relevant representative of peritoneal dialysis (PD) for decades. PI is a very serious complication of PD and is a source of concern because of its high incidence. Each episode carries clinical consequences for the patient, increases in treatment costs, hospital admissions, technical failures and risk of death, especially in the 30 days following an episode.\n\nThe risk of peritonitis depends on non-modifiable factors (such as age, sex, diabetes) and modifiable factors (such as anti-infective prophylaxis, catheter care, and training).\n\nIt is important to accurately analyze the effect of modifiable factors, as they are the most relevant in reducing the rate of peritonitis.\n\nPatient education is very important and can affect the success of the technique and clinical results. Therapeutic education has been considered a key factor in PD outcomes.\n\nThe PD nurse is responsible for training the patient and\u002For caregiver to be self-sufficient and autonomous in care, reinforce and highlight the importance of adherence to treatment, and promote safe actions to prevent technique-related infections when this one is made at home.\n\nThis is a pragmatic, retrospective-prospective (ambispective) study of educational intervention for patients with stage V advanced chronic kidney disease and those with cardiorenal syndrome starting a peritoneal dialysis program.\n\nA retrospective control group with patients starting PD before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study and they will be implemented a new educational intervention based on a systematic review that has been carried out with the most recent evidence.",[143,148],{"label":144,"type":6,"description":145,"interventionNames":146},"Retrospective control group","This is the PD population sample from before January 2020.",[147],"Behavioral: Data collection from the patient's clinical history",{"label":149,"type":150,"description":151,"interventionNames":152},"Prospective study group","EXPERIMENTAL","It will be the incident patients in PD who will receive the educational intervention contained in this project and whose results will be compared with the control group.",[153],"Behavioral: Intervention to reduce infectious complications of peritoneal dialysis",[155,161],{"type":156,"name":157,"description":158,"armGroupLabels":159,"otherNames":160},"BEHAVIORAL","Intervention to reduce infectious complications of peritoneal dialysis","* Before catheter placement: The nurse and doctor provide the patient and\u002For caregiver with a PD simulation.\n* Initial training: from the placement of the catheter to the beginning of the technique at home, approximately 4 weeks, 6 and 7 sessions, duration 1-2 hours per session. Individualized learning taking into account learning abilities and education. It includes the explanation of the PD and the display of informational pictograms\u002Fcapsules.\n* Step-by-step teaching: peritoneal exchange, peritoneal orifice care, administration of intraperitoneal medication, recording of constants, detection of complications and risk behaviors.\n* Nutritional education and water intake.\n* Administration of the Objective Structured Assessment (OSA) checklist.\n* Retraining: between the 1st and 3rd month of the start, after an episode of peritonitis and\u002For hospitalization, risk behaviors, functional\u002Fcognitive impairment, passivity\u002Fdemotivation behaviors, and regularly once the year.",[149],[149],{"type":156,"name":162,"description":163,"armGroupLabels":164,"otherNames":165},"Data collection from the patient's clinical history","Data collection from the patient's clinical history because this new standardized educational intervention was not used.",[144],[144],[167],{"name":168,"role":169,"phone":170,"phoneExt":133,"email":171},"Elena Fernàndez Labadía, PhD student","CONTACT","+34626-321-345","elena.fernandez@udl.cat",{"type":173,"investigatorFullName":174,"investigatorTitle":175,"investigatorAffiliation":5,"oldNameTitle":133,"oldOrganization":133},"PRINCIPAL_INVESTIGATOR","Elena Fernandez Labadia","PhD student","100557327",false,"NCT06536673","Intervention to Reduce Infectious Complications of Peritoneal Dialysis","Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis","Inclusion Criteria:\n\n* Patients \\>18 years of age\n* Medically stable\n* Who can perform dialysis themselves or with the help of a caregiver willing to participate in the study and sign the informed consent will be included\n\nExclusion Criteria:\n\n* Patients with psychiatric, psychological disorders and social (language barrier included)\n* Who do not have a formal\u002Finformal caregiver\n* Those who due to medical needs cannot continue with the standard schedule, pregnant women, participants who suffered peritonitis before receiving the educational intervention","ALL","18 Years",{"count":185,"type":186},80,"ESTIMATED","INTERVENTIONAL",[189],"NA","Peritonitis is a common and serious complication of peritoneal dialysis (PD) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion.",[192],"Peritoneal Infection",[194,195,108],"Educational intervention","Peritoneal dialysis","NOT_YET_RECRUITING","2024-09-06",{"date":199,"type":200},"2024-09-19","ACTUAL",{"date":202,"type":186},"2024-09-15",{"date":204,"type":186},"2025-09-01",{"name":5,"class":6}]