An interventional study of Intensive training group in Risk Reduction, sponsored by Kook-Hwan Oh. Completed at 6 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by Kook-Hwan Oh · Not applicable, Interventional, and Treatment
Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers.
Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference.
From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.
This study will be conducted as multi-center, open-label, randomized, controlled trial. One hundred four patient starting PD will be randomized into two training groups. Patients in the conventional training group (CG) will be given non-standardized in-center conventional training programs plus two sessions of training by home visit, while those in intensive training group (IG) given in-center conventional training programs plus repeated home visits regularly over 24-month period (total thirteen visits). The primary end point of the study is exit site infection (ESI). Secondary endpoints are peritonitis and all-cause infection. Generalized Estimating Equations will be used to assess the adjusted effect of training level on the ESI and Cox regression model employed to evaluate the effect on the peritonitis and other secondary outcomes.
This is the only study on the registry with Kook-Hwan Oh as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
in-center conventional training programs + two home visits
in-center conventional training programs + an extra structured patient home visits repeatedly and regularly
Behavioral: Intensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum
Exit site infection
Time frame: 24 months
time to the first peritonitis
Time frame: 24 months
Number of ESIs per patient-month
Time frame: 24 months
Days of hospitalization per year
Time frame: 24 months
Systolic pressure and diastolic pressure measured at every visit
Time frame: 24 months
Average number of antihypertensive medications
Time frame: 24 months
Kt/V
Time frame: 24 months
Residual renal function
Time frame: 24 months
Fluid balance score
Time frame: 24 months
Patient survival rate
Time frame: 24 months
Total medical cost
Time frame: 24 months
Total hours of education and training
Time frame: 24 months
Unplanned home visit and education by peritoneal dialysis nurse
Time frame: 24 months
Compliance score of patients
Time frame: 24 months
HbA1c only for patients with diabetes
Time frame: 24 months
Intact PTH level
Time frame: 24 months
Hemoglobin level
Time frame: 24 months
nPNA
Time frame: 24 months
QOL
Time frame: 24 months
SGA
Time frame: 24 months
K level
Time frame: 24 months
Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis
Time frame: 24 months
Technical survival rate
Time frame: 24 months
peritonitis rate
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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