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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 111
- 试验地点
- 16
- 主要终点
- Measure of the global self-esteem by the Rosenberg scale (RSES)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measure of the global self-esteem by the Rosenberg scale (RSES)
时间窗: At day 0
Score range : 10 - 40. High scores indicate hight self esteem.
次要结局
- Evaluation of depression and anxiety by Hamilton's scale (HAD)(At day 0, at month 6)
- Neuropsychological evaluation (WAIS-III battery composite GREFEX, CVLT)(At day 0)
- Rating Scale vesico-sphincter and anorectal function (ISCOS)(At day 0, at month 6)
- Evaluation scale for the achievement of self catheterizing(At day 0, at month 6)
- Observance of holding of the mictionnel catalog(At month 6)
- Observance of the appointment(At month 6)
- Scale functional mobility and transfers (SCIM III)(At day 0)
- Measure of the global self-esteem by the Rosenberg scale (RSES)(At month 6)
- Measure of auto-efficiency experienced scale for Medullary Injured (MSES)(At Day 0)