Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury (ESTIME)
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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 |
- 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.
- 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 |
| 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 |
Patient seen in university hospitals or in rehabilitation clinic
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| Contact: Jacques Kerdraon, MD | 2 99 28 97 63 ext +33 | Jacques.KERDRAON@chu-rennes.fr |
| 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 | |
| Principal Investigator: | Jacques Kerdraon, MD | CHU Rennes |
| Study Chair: | Reymann Jean Michel, PhD | CHU de Rennes |
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: | October 1, 2012 |
| 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:
|
Spina Bifida Cystica Spinal Dysraphism Spinal Cord Injuries Neural Tube Defects Nervous System Malformations Nervous System Diseases |
Congenital Abnormalities Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013