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

NCT06396377 | Completed

• 2 other identifiers: RBHP 2023 MARTIN2023-A00383-42
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia Alzheimers

Keywords

Alzheimer; Reborn doll; agitation; behavioural disorders; cognitive disorders

Outcome Measures

Primary Outcomes (1)

• Episodes of resident agitation using the Cohen Mansfield scale

  The number of episodes of agitation will be collected weekly by the nursing assistant or nurse in charge of monitoring, by compiling the events reported on a resident monitoring document with the time of recording. The characterization of these episodes should correspond to one of the items on the Cohen Mansfield scale. Two consecutive episodes cannot be counted if they are less than one hour apart (and will therefore be counted as a single event). Follow-up should be strictly identical, whether the resident belongs to the intervention group or the control group.

  During the study period (4 weeks)

Secondary Outcomes (7)

• Factors that can affect doll benefits: gender, age, pathology, Charlson Comorbidity Index, doll identifier.

  Inclusion

• Drug treatments

  During the study period (4 weeks)

• Average exposure time to Reborn®dolls

  During the study period (4 weeks)

• Therapeutic evaluation scale

  During the study period (4 weeks)

• Quality of working life questionnaire

  During the study period (4 weeks)

Study Arms (2)

Control

NO INTERVENTION

If the resident is randomized to the control group, the resident will not receive a reborn®doll. The investigating team will observe the resident's behavior as if he or she were receiving a doll.

Reborn doll

EXPERIMENTAL

The investigating team will give the Reborn®doll to the resident, during a 45-minute to 1-hour workshop, twice a week for 3 weeks. The OTs, wrapped in a blanket, are presented to the residents by a member of the investigative team trained in reborning , in the resident's room. If the resident is not in his/her room, he/she will be taken back to receive his/her doll. In the case of double rooms, it will be necessary to assess whether or not to leave the room-mate in the room, in order to limit the loss of reference points for the resident concerned by the study. The caregiver lets the resident appropriate and recognize the OT, so that he or she can find meaning in it and awaken his or her sensory memory.In total, the patient will be exposed to OT 6 times.

Device: Reborn doll (Therapeutic object - OT)

Interventions

Reborn doll (Therapeutic object - OT) DEVICE

If the resident is randomized to the intervention group, the investigating team will give the Reborn®doll to the resident, during a 45-minute to 1-hour workshop, twice a week for 3 weeks. The OTs, wrapped in a blanket, are presented to the residents by a member of the investigative team trained in reborning , in the resident's room. If the resident is not in his/her room, he/she will be taken back to receive his/her doll. In the case of double rooms, it will be necessary to assess whether or not to leave the room-mate in the room, in order to limit the loss of reference points for the resident concerned by the study. The caregiver lets the resident appropriate and recognize the OT, so that he or she can find meaning in it and awaken his or her sensory memory.In total, the patient will be exposed to OT 6 times.

Reborn doll

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation; Mental Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Cognition Disorders

Study Officials

• Chloé Afonso

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized parallel-arm trial.

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: May 2, 2024
• Study Start: September 16, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

FR (1)