To study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (hereafter called *new type of follow-up*) can reduce the incidence of peritonitis, reduce the technique failure rate related to peritonitis, and…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study if a new type of follow up of PD patients with regular testing of
their theoretical and practical knowledge can prolong the time to first
peritonitis an reduce the incidence of peritonitis compared to standard
treatment.
Secondary outcome
To study risk factors for peritonitis, especially diabetes and age and if a new
type of follow up can reduce the technique-failure rate related to peritonitis.
To study if a new type of follow up can reduce the time of hospitalisation
related to peritonitis compared to standard treatment
Background summary
Peritonitis is a significant problem in peritoneal dialysis (PD). Some patients
may suffer episodes of peritonitis often while others never get such an
infection. The risk to suffer an episode of peritonitis is greater during the
first year of PD treatment than later. It has been demonstrated that
non-compliance with the PD protocol is an important risk factor for
peritonitis. We therefore want to study if structured follow-up of PD patients*
theoretical and practical knowledge with focus on infection prophylaxis can
reduce the incidence of peritonitis compared to a routine regimen.
Study objective
To study if regular follow-up of PD patients with testing of their theoretical
and practical knowledge (hereafter called *new type of follow-up*) can reduce
the incidence of peritonitis, reduce the technique failure rate related to
peritonitis, and reduce the time of hospitalization related to peritonitis
compared to a routine regimen.
Study design
The study is a randomized, multi-centre investigation of 750 new PD patients in
Norway, Sweden, Denmark, Finland, Estonia, Latvia and Holland. It includes a
follow-up group and a control group. The follow-up group will undergo regular
testing of theoretical and practical knowledge regarding PD with focus on
infection prophylaxis including retraining if needed. The control group will be
treated according to the routines of the centre.
Intervention
1. The patient should fill in a questionnaire with theoretical and practical
questions with focus on infection and infection prophylaxis during PD
treatment.
Goal: At least 80% of the questions should be correct. If the goal is not
reached, further training should be given until the goal is reached.
2. The patient will do a practical test including hand disinfection, PD
exchange technique, exit-site care. Hand disinfection skills will be controlled
with the help of fluorescent alcohol and a UV lamp.
Goal: All steps of the practical test should be correctly performed. If not,
further training will be given until the goal is reached.
Study burden and risks
Time investment of 60-120 minutes per visit, with a total of 480-960 minutes
during the 3 years follow-up. There are no risks associated with this study.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Able to perform peritoneal dialysis without assistance
Exclusion criteria
Previous PD-treatment less than 2 years ago
Peritonitis before inclusion
Active malignancy
Participation in other studies during the study period, which may affect the outcome of the present study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01293799 |
| CCMO | NL35699.018.11 |