Clinical Trial: Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Paral

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Rennes University Hospital

Current Primary Outcome: Measure of the global self-esteem by the Rosenberg scale (RSES) [ Time Frame: At day 0 ]

Score range : 10 - 40. High scores indicate hight self esteem.


Original Primary Outcome: Measure of the global self-esteem by the Rosenberg scale (RSES) [ Time Frame: At day 0 ]

Current Secondary Outcome:

  • Evaluation of depression and anxiety by Hamilton's scale (HAD) [ Time Frame: At day 0, at month 6 ]
    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 ]
    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 ]
    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 ]
    14 binary items
  • Scale functional mobility and transfers (SCIM III) [ Time Frame: At day 0 ]

    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 ]
    Score range : 10 - 40. High scores indicate hight self esteem.
  • Observance of the appointment [ Time Frame: At month 6 ]
  • Observance of holding of the mictionnel catalog [ Time Frame: At month 6 ]
  • Measure of auto-efficiency experienced scale for Medullary Injured (MSES) [ Time Frame: At Day 0 ]
    • 16 items ranging from 1 to 7
    • Range 16 - 112
    • High scores correspond to low level of percieved auto-efficiency


Original Secondary Outcome:

  • Evaluation of depression and anxiety by Hamilton's scale (HAD) [ Time Frame: At day 0, at month 6 ]
  • Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT) [ Time Frame: At day 0 ]
  • Rating Scale vesico-sphincter and anorectal function (ISCOS) [ Time Frame: At day 0, at month 6 ]
  • Evaluation scale for the achievement of self catheterizing [ Time Frame: At day 0, at month 6 ]
  • Scale functional mobility and transfers (SCIM III) [ Time Frame: At day 0 ]
  • Measure of the global self-esteem by the Rosenberg scale (RSES) [ Time Frame: At month 6 ]
  • Observance of the appointment [ Time Frame: At month 6 ]
  • Observance of holding of the mictionnel catalog [ Time Frame: At month 6 ]
  • Measure of auto-efficiency experienced scale for Medullary Injured (MSES) [ Time Frame: At Day 0 ]


Information By: Rennes University Hospital

Dates:
Date Received: May 16, 2012
Date Started: January 2012
Date Completion: December 2017
Last Updated: June 14, 2016
Last Verified: June 2016