Ignite Creation Date:
2024-05-06 @ 9:01 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02880969
Status:
UNKNOWN
Last Update Posted:
2016-08-26
First Post:
2016-08-12
Brief Title:
Effect of Individual and Populational Determinants on End Stage Renal Disease Children Quality of Life During Dialysis Period
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CQFD
Brief Summary:
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 patients 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 childrens QoL studying individual and populational factors is necessary
The aim of the study is to assess the influence of individual and populational determinants on childrens 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
Patients 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 Childs 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
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 childrens QoL studying individual and populational factors is necessary
The aim of the study is to assess the influence of individual and populational determinants on childrens 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
Patients 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 Childs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-A00761-42 | OTHER | Ansm | None |