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

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.

Study Overview

• Status: Completed
• Conditions: Problem Behavior; Dementia; Elderly; Adapted Garment Prototype; Sphincter Disorders
• Intervention / Treatment: Other: garment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Mekchoudi; Phone Number: 03.22.08.83.70; Email: mekchoudi.sophie@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80000
      • Centre Hospitalier Universitaire d'Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 exclusion criteria

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional garment	Other: garment; patient randomized in the experimental arm will wear the specially designed garment
Experimental: prototype garment	Other: garment; patient randomized in the experimental arm will wear the specially designed garment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation of satisfaction score between both groups of patients	Satisfaction score will be measured with an home-made questionary. Higher scores for highest satisfactory. the questionary is composed of 10 questions.	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: elderly; Dementia; adapted garment prototype; patient dignity; behavioral troubles; sphincter disorders
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease; Problem Behavior; Dementia
• Other Study ID Numbers: PI2018_843_0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No