- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02880969
Effect of Individual and Populational Determinants on End Stage Renal Disease Children Quality of Life, During Dialysis Period. (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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Marseille, Frankrike, 13354
- Assistance Publique Hopitaux de Marseille
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Patient with end stage renal disease undergoing dialysis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Numbers of patient with identicals factors influencing chronic dialysed children quality of life as assessed by Kidscreen 10 scales
Tidsramme: 7 months
|
7 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Michel TSIMARATOS, MD/PhD, Assistance Publique Hopitaux de Marseille
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2012-22
- 2012-A00761-42 (Annen identifikator: Ansm)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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