跳至主要内容
临床试验/NCT05649839
NCT05649839进行中(未招募)不适用

Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
variation of satisfaction score between both groups of patients

研究概览

简要总结

Alzheimer's disease and related disorders (ADRD) are diseases whose frequency is increasing in elderly subjects. Their evolution is marked by the occurrence, in addition to cognitive disorders, of increasingly disruptive behavioral disorders that interfere with their management, as well as impairment of basic functions, including the occurrence of sphincter disorders responsible for daytime and nighttime urinary and fecal incontinence. These disorders are present in more than 80% of LAM patients and are of multifactorial origin.

It is difficult to get patients to accept wearing the necessary protection. They tend to remove or tear them off. This can frequently lead to stressful situations of agitation and inappropriate behavior for patients and uncomfortable continence management for caregivers.

In order not to be forced to use heavy physical restraints or therapeutics that promote drowsiness so that the patient cannot remove his or her protections, the only effective response today is to wear a garment. Unfortunately, the ones that exist today are strictly functional and are worn at night.

The use of such garments, during the day, in this indication, is therefore a common and usual practice today.

This results in an ethical problem for the caregivers. Indeed, worn during the day, rompers give the impression to the latter that they show a devaluing, infantilizing or even degrading image of the elderly person. This practice, although common and accepted because it is the only recourse to physical and chemical restraints to preserve the cleanliness and presentation of elderly patients, could lead to an impaired dignity which could be badly experienced by their close circle of friends and family as well as by the carers and could also have an impact on the overall effectiveness of the care .

This is the first time that a multi-professional team integrating doctors, caregivers, occupational therapists and engineers have reflected on the design of a garment that meets the expectations of caregivers, patients and their families. The romper thus designed must be able to retain the aesthetic characteristics of a garment that meets the tastes of the elderly while respecting their dignity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the EHPAD at the St-Victor center - CHU Amiens-Picardie,
  • •patients with behavioral and sphincter disorders justifying the prescription of a romper.
  • •signature of a consent

排除标准

  • •Exclusion Criteria:
  • •No next of kin
  • •Patients in terminal palliative care
  • •Patients whose morphology does not allow the use of prototypes (no adapted size)

研究组 & 干预措施

conventional garment

Active Comparator

干预措施: garment (Other)

prototype garment

Experimental

干预措施: garment (Other)

结局指标

主要结局

variation of satisfaction score between both groups of patients

时间窗: 6 months

Satisfaction score will be measured with an home-made questionary. Higher scores for highest satisfactory. the questionary is composed of 10 questions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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