Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)

Conditions
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Risk Reduction

Intervention / Treatment
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* Behavioral: Intensive training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incident patients who have PD catheter insertion for starting PD with Baxter solutions > 20 yr of age Exclusion Criteria: Patients who have undergone dialysis or received kidney transplant (note, however, that patients who are currently undergoing emergency hemodialysis temporarily right before the PD do not fall under the exclusion criteria.) Patients who are likely to receive kidney transplant or shift to hemodialysis within the following 1 year Patients diagnosed with acute inflammatory disease for the past three months Patients currently diagnosed with chronic inflammatory disease Currently pregnant or breastfeeding Patients who are involved in other clinical trial within 30 days prior to enrollment Patients who are currently hospitalized in care facilities such as nursing home, etc., or those who are expected to be hospitalized for the duration of the clinical test Patients who cannot perform PD by themselves Patients considered by the person in charge of the clinical test to have difficulty in participating in this clinical test

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional training group<br>in-center conventional training programs + two home visits | |
| Experimental: Intensive training group<br>in-center conventional training programs + an extra structured patient home visits repeatedly and regularly | Behavioral: Intensive training group<br>* an extra structured patient centric training program on PD technique and diet according to the developed training curriculum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exit site infection |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to the first peritonitis |  | 24 months | 
| Number of ESIs per patient-month |  | 24 months | 
| Days of hospitalization per year |  | 24 months | 
| Systolic pressure and diastolic pressure measured at every visit |  | 24 months | 
| Average number of antihypertensive medications |  | 24 months | 
| Kt/V |  | 24 months | 
| Residual renal function |  | 24 months | 
| Fluid balance score |  | 24 months | 
| Patient survival rate |  | 24 months | 
| Total medical cost |  | 24 months | 
| Total hours of education and training |  | 24 months | 
| Unplanned home visit and education by peritoneal dialysis nurse |  | 24 months | 
| Compliance score of patients |  | 24 months | 
| HbA1c only for patients with diabetes |  | 24 months | 
| Intact PTH level |  | 24 months | 
| Hemoglobin level |  | 24 months | 
| nPNA |  | 24 months | 
| QOL |  | 24 months | 
| SGA |  | 24 months | 
| K level |  | 24 months | 
| Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis |  | 24 months | 
| Technical survival rate |  | 24 months | 
| peritonitis rate |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal dialysis