Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury (ESTIME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01606618
First received: May 16, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder.

The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.


Condition
Spina Bifida Aperta
Acquired Traumatic Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Psychosocial Determinants of Observance of Monitoring Neuro-urological in Spina-bifida Adult Patients and in Spinal Cord Injury Patients: a Prospective, Comparative, Multicenter With Parallel Groups Study

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Measure of the global self-esteem by the Rosenberg scale (RSES) [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
    Score range : 10 - 40. High scores indicate hight self esteem.


Secondary Outcome Measures:
  • Evaluation of depression and anxiety by Hamilton's scale (HAD) [ Time Frame: At day 0, at month 6 ] [ Designated as safety issue: No ]
    Score range : 0 - 21. High scores indicate a hight level of symptoms.

  • Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT) [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
    Battery of test exploring executives functions. High scores indicate high level of executive functions.

  • Rating Scale vesico-sphincter and anorectal function (ISCOS) [ Time Frame: At day 0, at month 6 ] [ Designated as safety issue: No ]
    High scores indicate high vesico-sphincter and anorectal dysfunction

  • Evaluation scale for the achievement of self catheterizing [ Time Frame: At day 0, at month 6 ] [ Designated as safety issue: No ]
    14 binary items

  • Scale functional mobility and transfers (SCIM III) [ Time Frame: At day 0 ] [ Designated as safety issue: No ]

    The SCIM is a disability scale in order to describe patients' ability to accomplish activities of daily living and to make functional assessments of this population more sensitive to changes.

    SCIM-III is comprised of 19 items in 3 subscales, which are:

    (i) self-care (sub-score 0-20); (ii) respiration and sphincter management (sub-score 0-40); (iii) mobility (sub-score 0-40). The mobility subscale is further sub-divided to assess mobility "in room and toilet" and for "indoors and outdoors, on an even surface".

    The total score ranges from 0 to 100.


  • Measure of the global self-esteem by the Rosenberg scale (RSES) [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    Score range : 10 - 40. High scores indicate hight self esteem.

  • Observance of the appointment [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
  • Observance of holding of the mictionnel catalog [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
  • Measure of auto-efficiency experienced scale for Medullary Injured (MSES) [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
    • 16 items ranging from 1 to 7
    • Range 16 - 112
    • High scores correspond to low level of percieved auto-efficiency


Estimated Enrollment: 330
Study Start Date: January 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spina bifida aperta
Acquired traumatic spinal cord injury

Detailed Description:

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. The risk of developing a terminal renal insufficiency is eight times higher than the risk in the general population and twice as important as in acquired spinal cord injury. This risk continues to evolve with advancing age.

One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder. However, some studies report that nearly two thirds of these patients are not monitored at regular neuro-urological in the adulthood. Different psychosocial determinants were analyzed as potential markers of the impact of chronic diseases from childhood to adulthood and could account for the disparity of follow-up and access to healthcare. Among these, the self-esteem is a psychological dimension of analysis particularly relevant within the framework of chronic states inherited from the childhood.

The investigators formulate the hypothesis that global self-esteem and lower perceived self-efficacy may be a causal predictive factor of a reduced access to the continence and a lower compliance monitoring in adult patients with a spina bifida.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient seen in university hospitals or in rehabilitation clinic

Criteria

Inclusion Criteria:

  • Patients with a spina bifida aperta or an acquired traumatic spinal cord injury dating more than two years, the level of injury being below D12 and higher S1 (Score ASIA A).
  • Age between 18 and 60
  • Knowing how to read, write, count
  • Having given their free, informed and in writing consent (an information is also given to the reliable person when it exists)
  • Affiliated to the National Health Service

Exclusion Criteria:

  • Psychiatric history requiring an hospitalization in a specialized unit during more than two months
  • Score MMS lower than 27 ( GRECO version)
  • Serious associated pathology or associated pathology which could interfer with the management of vesico-sphincteral disorders
  • Neurosurgery, dating from less than one year
  • Symptoms of dysfunction of ventricular bypass valve at the time of inclusion
  • Clinical epileptic attack within six months prior to inclusion
  • Pregnancy or breastfeeding
  • Simultaneous inclusion in an another therapeutic protocol or period of exclusion from an another protocol
  • Traumatic spinal cord injury acquired before age 16
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606618

Contacts
Contact: Jacques Kerdraon, MD 2 99 28 97 63 ext +33 Jacques.KERDRAON@chu-rennes.fr

Locations
France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Bernard Parratte         
Principal Investigator: Bernard Parratte, MD         
Clinique Saint Augustin Recruiting
Bordeaux, France, 33000
Contact: Marianne de Sèze, MD         
Principal Investigator: Marianne de Sèze, MD         
CHU de Lille Recruiting
Lille, France, 59000
Contact: Anne Blanchard Dauphin, MD         
Principal Investigator: Anne Blanchard Dauphin, MD         
Urologie CH Lyon Sud et Hôpital Henry Gabrielle Recruiting
Lyon, France, 69000
Contact: Alain Ruffion, MD         
Principal Investigator: Alain Ruffion, MD         
APHM - Hôpital de la Conception Service de chirurgie urologique et transplantation rénale Recruiting
Marseille, France, 13005
Contact: Gilles Karsenty, MD         
Principal Investigator: Gilles Karsenty, MD         
MPR neurologique CHU de Nantes Recruiting
Nantes, France, 44000
Contact: Brigitte Perrouin Verbe, MD         
Principal Investigator: Brigitte Perrouin Verbe, MD         
APHP Raymond Poincaré Recruiting
Paris, France, 75000
Contact: Pierre Denys, MD         
Principal Investigator: Pierre Denys, MD         
APHP Rothschild Recruiting
Paris, France, 75000
Contact: Gilberte Robain, MD         
Principal Investigator: Gilberte Robain, MD         
Neuro-urologie et explorations périnéales, APHP Tenon Recruiting
Paris, France, 75000
Contact: Gérard Amarenco, MD         
Principal Investigator: Gerard Amarenco, MD         
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE Recruiting
Ploemeur, France, 56270
Contact: Jacques Kerdraon, MD    2 97 82 60 60 ext +33      
Principal Investigator: Loïc Lemoigne, MD         
Hôpital Pontchaillou - CHU de Rennes Recruiting
Rennes, France, 35000
Contact: Isabelle Bonan, MD         
Principal Investigator: Isabelle Bonan, MD         
MPR St Hélier Recruiting
Rennes, France, 35000
Contact: Philippe Gallien       philippe.gallien@chu-rennes.fr   
Principal Investigator: Philippe Gallien, MD         
CHU de Rennes CR Spina bifida Recruiting
Rennes, France, 35000
Contact: Jacques Kerdraon       Jacques.KERDRAON@chu-rennes.fr   
Principal Investigator: Jacques Kerdraon, MD         
Sub-Investigator: Andrea Manunta, MD         
Sub-Investigator: Isabelle Berkelmans, MD         
Urologie, CHU de Rouen Recruiting
Rouen, France, 76000
Contact: Philippe Grise, MD         
Principal Investigator: Philippe Grise, MD         
Urologie CHU Rangueuil Toulouse Recruiting
Toulouse, France, 31000
Contact: Xavier Game, MD         
Principal Investigator: Xavier Game, MD         
MPR CHU Rangueuil Recruiting
Toulouse, France, 31000
Contact: Evelyne Castel Lacanal, MD         
Principal Investigator: Evelyne Castel Lacanal, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Jacques Kerdraon, MD CHU Rennes
Study Chair: Reymann Jean Michel, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01606618     History of Changes
Other Study ID Numbers: B110797-30
Study First Received: May 16, 2012
Last Updated: April 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Self-esteem
Spina Bifida
Spinal cord injury

Additional relevant MeSH terms:
Nervous System Malformations
Spina Bifida Cystica
Spinal Cord Injuries
Spinal Dysraphism
Wounds and Injuries
Neural Tube Defects
Nervous System Diseases
Congenital Abnormalities
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 29, 2014