This study aims to assess the illness perceptions and HRQoL in patients with lupus nephritis. Is HRQol higher in patients that received the Euro-Lupus schema compared to patients treated according to the NIH-protocol? A second aim is to screen the…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important study parameter is the difference in quality of life between
patients that received the NIH treatment and patients that were treated
according to the Euro-Lupus schema. Analysis of the drawings will encover which
parameters are of meaning, thus in which the two groups differ from each
other.
In addition, the relation between the level of HRQol and illness perceptions as
well as disease activity parameters will be investigated.
Secondary outcome
The presence of chimeric cells in blood of the female participants.
Background summary
Litte is known about health-related quality of lide (HRQoL) in patients with
SLE, whereas the disease burden is thought to be high. Lupus nephritis is a
common manifestation of the disease which demands a treatment with strong
immunosuppressive agents. New treatments do not only try to accomplish a beter
recovery, but also to lower the disaese burden. This study compares the old
NIH-protocol with the new Euro-lupus protocol in effect on quality of life. It
is hypothesized that HRQoL will be higher in patients who received the
Euro-lupus treatment.
Study objective
This study aims to assess the illness perceptions and HRQoL in patients with
lupus nephritis. Is HRQol higher in patients that received the Euro-Lupus
schema compared to patients treated according to the NIH-protocol? A second aim
is to screen the women participating in this study for the presence of chimeric
cells in their blood.
Study design
The participants will have an appointment at the departement of kidney diseases
with the researcher. The participant will fill out three questionnaires, the
Medical Outcomes Study Short Form 36 (MOS-SF-36), the SLE Sympotom Checklist
(SSC) and the Brief Illness Perception Questionaire (B-IPQ). After filling out
these questionnaires, the participants will be asked to make two drawings, one
of their kidneys at the time the diagnosis lupus nefritis was made and one
shortly after treatment.
The women participating in this study will fill out a forfth questionnaire
about the pregnancies they may have had.
Finally, a blood sample will be taken from these women to screen for the
presence of chimeric cells.
Study burden and risks
The burden for the participant is very small. Only one appointment with the
researcher will be necessary. The women in the study will probably need one
hour to complete the procedure, the men will finish in about forty-five
minutes.
Postbus 9555
2333 RB Leiden
Nederland
Postbus 9555
2333 RB Leiden
Nederland
Listed location countries
Age
Inclusion criteria
A diagnosis of proliferative lupus nephritis and a received treatment according to either the NIH or the Euro-Lupus protocol.
Exclusion criteria
Patients with proliferative lupus-nephritis who were not treated according to the NIH- or Euro-Lupus protocol and patients with a diagnosis of non-proliferative lupus nephritis are excluded from the 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 |
|---|---|
| CCMO | NL20636.058.07 |