Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Education |
Behavioral: Intensive training group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- number of hospitalization per year [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to the first peritonitis episode [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to the first ESI episode [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Number of ESIs per patient-month [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Days of hospitalization per year [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Systolic pressure and diastolic pressure measured at every visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Average number of antihypertensive medications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Kt/V [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Residual renal function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Fluid balance score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Patient survival rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Total medical cost [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Total hours of education and training [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Unplanned home visit and education by peritoneal dialysis nurse [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Compliance score of patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- HbA1c only for patients with diabetes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Intact PTH level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Hemoglobin level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- nPNA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- QOL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- SGA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- K level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Technical survival rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- peritonitis rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Conventional training group
in-center conventional training programs
|
|
|
Experimental: Intensive training group
in-center conventional training programs + an extra structured patient centric training program
|
Behavioral: Intensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Incident patients 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
Contacts and Locations| Contact: Kook-Hwan Oh, M.D., PhD | 82-2-2072-0776 | khoh@snu.ac.kr |
| Korea, Republic of | |
| Wonkwang University, Sanbon Medical Center | Recruiting |
| Gunpo, Gyeonggi-do, Korea, Republic of | |
| Contact: Hyun-Wook Kim, MD | |
| Hallym University Sacred Hospital Puyngchon | Recruiting |
| Anyang, Korea, Republic of | |
| Contact: Seong Gyun Kim | |
| Gachon University Gil Hospital | Recruiting |
| Incheon, Korea, Republic of | |
| Contact: Jae Hyun Chang, M.D. | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Kook-Hawn Oh, MD.,PhD 82-2-2072-0776 khoh@anu.ac.kr | |
| Principal Investigator: Kook-Hawn Oh | |
| Hallym University Sacred Hospital Gangdong | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Ji Eun Oh | |
| Eulji Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Young-Hwan Hwang | |
| Principal Investigator: | Kook-Hwan Oh, M.D., PhD | Seoul National University |
More Information
No publications provided
| Responsible Party: | Kook-Hwan Oh, Associate Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01204619 History of Changes |
| Other Study ID Numbers: | TEACH |
| Study First Received: | September 16, 2010 |
| Last Updated: | June 6, 2012 |
| Health Authority: | Korea: Institutional Review Board, Seoul National University Hospital |
Keywords provided by Seoul National University Hospital:
|
peritoneal dialysis |
ClinicalTrials.gov processed this record on May 23, 2013