Effect of Individual and Populational Determinants on End Stage Renal Disease Children Quality of Life, During Dialysis Period. (CQFD)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Kidney Dysfunctions

Treatments: Behavioral: answering questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT02880969

2012-A00761-42 (Other Identifier)

2012-22

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

Patient with end stage renal disease undergoing dialysis

Experimental group

Treatment:

Behavioral: answering questionnaires