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NCT06396377Completed

Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder

Interest of the Reborn® Doll as a Therapeutic Object in the Care of Residents With Alzheimer's Disease or a Related Disorder : Pilote Study

Source: ClinicalTrials.gov · Last updated 18 Dec 2024

Brief summary (registry, in English)

The primary objective of this study is to evaluate the benefits of the Reborn®doll as an OT for the care of residents with Alzheimer's disease or related disorders, by assessing the frequency of resident agitation. The secondary objectives are to study the frequency of treatments, evaluate the average time of exposure to the Reborn® doll, study the behavior of the residents, study the interest of this therapeutic workshop, thanks to an evaluation grid and finally study the repercussions of this OT on the nursing staff.

Status (registry)
Completed
Study type
Interventional
Enrollment
24 (actual)
First submitted
5 Apr 2024
Start date
16 Sept 2024
Primary completion date
13 Dec 2024
Lead sponsor
University Hospital, Clermont-Ferrand
NCT number
NCT06396377

What you commit to

  • Study type: Interventional
  • Participants enrolled: 24
  • From 16 Sept 2024 to the primary completion date, 13 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Resident or representative refusing to participate
  • Resident under judicial protection

Who the study is looking for

  • Resident aged 65 and over
  • Moderate to severe cognitive impairment diagnosed using the NPI-ES scale
  • Behavioral disorders (agitation, aggression, anxiety, apathy) assessed using the NPI-ES scale
  • Covered by a social security plan
  • Written consent of representative (tutor/ curator/trusted person)

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.