Rates of Hospitalization in Home Care Assisted Peritoneal Dialysis
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 9, 2007 | ||||||||
| Last Updated Date | February 6, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00499213 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Rates of Hospitalization in Home Care Assisted Peritoneal Dialysis | ||||||||
| Official Title ICMJE | Home Care Assisted Peritoneal Dialysis: The Impact of Expanding Eligibility for Peritoneal Dialysis on Rates of Hospitalization | ||||||||
| Brief Summary | We have developed and implemented a program that offers home care assistance to patients wishing to perform home peritoneal dialysis, but are unable to do it for themselves. This study is being conducted to ensure the safety of this dialysis program and specifically, to see if the risk of being hospitalized is increased when this therapy is provided to patients. |
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| Detailed Description | The cost of caring for patients with kidney failure is growing at an alarming rate and accounts for up to 7% of health care expenditures in developed countries. The majority of the cost is due to in-centre hemodialysis (HD) because of high operating costs and the capital investment required to build new dialysis units. In recent years, there has been a shortage of in-centre HD beds and it has become a priority to increase the number of patients being treated in their place of residence with therapies like peritoneal dialysis (PD). Unfortunately, many patients are unable to perform their own dialysis at home, a trend that will become more and more common as the population ages. We developed and implemented a program of home care assisted PD at Sunnybrook Health Sciences Centre where health care workers go into the home to assist patients with their treatment. The program has been a success and has garnered national attention. As a result, it has been adopted province-wide as part of the "Provincial PD Joint Initiative" and the Manitoba Renal Program is currently implementing a similar program to increase the use of PD. However, based on preliminary data, we are concerned that patients treated with home care assisted PD may have higher rates of hospitalization when compared to traditional forms of treatment (23.5 days per year of follow-up compared to 13 days per year of follow-up. If this is true it could have a significant impact on patient quality-of-life, cost-savings associated with PD, and resource allocation and planning in regional dialysis programs. This is of particular concern given that the provincial initiative has a goal of increasing the proportion of patients being treated with PD from the current 18% to 30% by 2010. The primary objective of this study is to determine if patients treated with home care assisted peritoneal dialysis are more likely to be hospitalized when compared to those treated with in-centre hemodialysis. The secondary objective of this study is to compare the occurrence of important outcome events including the need for access-related procedures, technique survival, and death in patients on home care assisted peritoneal dialysis compared to in-centre hemodialysis. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE | Rate of Hospitalization | ||||||||
| Intervention ICMJE | Procedure: Home Care Assisted Peritoneal Dialysis | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | July 2009 | ||||||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00499213 | ||||||||
| Other Study ID Numbers ICMJE | 07-22 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||||||
| Collaborators ICMJE | London Health Sciences Centre | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sunnybrook Health Sciences Centre | ||||||||
| Verification Date | July 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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