Kidney Dysfunctions Clinical Trial
— CQFD
End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of
graft availability. Being under dialysis requires a recourse to pluri-weekly magazine of
health care system, impacting negatively patient's quality of life (QoL) and their
entourage, at a psychological, physical and social level.
Although further studies have assessed QoL in ESRD grafted children, a lack of information
exists concerning patients' QoL during dialysis before graft. In addition, some limits could
be listed, these studies have small samples, 50 patients at all, and only clinical
determinants are studied. A larger clinical research assessing children's QoL studying
individual and populational factors is necessary.
The aim of the study is to assess the influence of individual and populational determinants
on children's QoL with ESRD, treated by dialysis.
Material & Method An exhaustive inclusion of patient with ESRD treated by dialysis will be
realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders,
ii) younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one
of the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and
the 31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be
re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be
signed by patient and their mainly caregiver.
Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and
VSP-A. In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment
(IPPA), optimism (Y-LOT) measures and socio-demographic data will be collected.
Self-administered questionnaires will be used for assessing caregivers' Qol (SF36), anxiety
(STAI-Y), coping (BriefCope situational format), health care system satisfaction (Care
quality scale) and burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by
caregivers will be assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition,
socio-demographic data, urban environment and economic environment will be collected.
Clinical data will be collected by health professionals.
Results expected A sample of 136 children with ESRD is expected for identifying individual
and populational factors which could influence chronic dialysed children QoL, in order to
propose adjustments to optimize these patients quality of life.
| Status | Active, not recruiting |
| Enrollment | 136 |
| Est. completion date | January 2017 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 18 Years |
| Eligibility |
Inclusion Criteria: - Minors patients treated by dialysis or on standby of graft availability Exclusion Criteria: - Minors patients treated by dialysis for less than 4 weeks |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Numbers of patient with identicals factors influencing chronic dialysed children quality of life as assessed by Kidscreen 10 scales | 7 months | No |