Skip to main content
OpenTrials
Completed

NCT Number: NCT06396377

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Alzheimers Aberrant Motor Behavior in Dementia Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

Dementia affects 50 million people worldwide, and this number is set to continue rising as the population ages. Indeed, the World Health Organization (WHO) expects this number to reach 82 million by 2030. At present, there is no cure for dementia. In order to limit the need for drug treatments for dementia-related symptoms (agitation, aggression), non-drug treatments can be used to improve residents' lives and soothe them. In the late 1960s, researchers turned their attention to non-medication therapies (snozelen concept, animal mediation, calinotherapy, Tovertafel, Carpe Diem, doll'therapy).

This doll is used by caregivers to calm anxiety attacks, aggression or apathy in residents with MND. The doll helps to calm the elderly by focusing them on an object. Several studies have shown that residents are calmed and feel valued by taking care of the doll. This also helps to avoid physical or chemical restraints, as well as the use of drug therapies in cases of agitation. Reborn® dolls are an evolution of Doll'therappy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Episodes of resident agitation using the Cohen Mansfield scale

    Time frame: During the study period (4 weeks)

    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.

Secondary outcomes

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

    Time frame: Inclusion

  2. Drug treatments

    Time frame: During the study period (4 weeks)

    Medication during study period (name/posology) if applicable (daily record)

  3. Average exposure time to Reborn®dolls

    Time frame: During the study period (4 weeks)

    Average exposure time to Reborn®dolls in minutes

  4. Therapeutic evaluation scale

    Time frame: During the study period (4 weeks)

    Therapeutic evaluation grid only on days when residents are in possession of the OT on the Crossway computerized file

  5. Quality of working life questionnaire

    Time frame: During the study period (4 weeks)

    Quality of working life questionnaire to be completed by nursing staff on the Friday of the observation week, and on the last Friday (last day of the study).

  6. Resident behavior following OT withdrawal

    Time frame: During the study period (4 weeks)

    Resident behavior following OT withdrawal (for experimental group). Observation of the care team.

  7. Resident behavior after OT exposure

    Time frame: During the study period (4 weeks)

    Resident behavior after OT exposure. Observation of the care team.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: PROTMA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 2, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.