Dementia AlzheimersPROTMANCT06396377
Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder
A study testing Reborn doll (Therapeutic object - OT) in people with Dementia Alzheimers, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- Reborn doll (Therapeutic object - OT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2024to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- Resident or representative refusing to participate
- Resident under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Dementia Alzheimers
- Being tested
- Reborn doll (Therapeutic object - OT)
- Keywords
- Alzheimer, Reborn doll, agitation, behavioural disorders, cognitive disorders
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Mental Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reborn doll (Therapeutic object - OT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the study period (4 weeks)
Secondary outcomes (7)
Factors that can affect doll benefits: gender, age, pathology, Charlson Comorbidity Index, doll identifier.
Measured: Inclusion
Drug treatments
Medication during study period (name/posology) if applicable (daily record)
Measured: During the study period (4 weeks)
Average exposure time to Reborn®dolls
Average exposure time to Reborn®dolls in minutes
Measured: During the study period (4 weeks)
Therapeutic evaluation scale
Therapeutic evaluation grid only on days when residents are in possession of the OT on the Crossway computerized file
Measured: During the study period (4 weeks)
Quality of working life questionnaire
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).
Measured: During the study period (4 weeks)
Resident behavior following OT withdrawal
Resident behavior following OT withdrawal (for experimental group). Observation of the care team.
Measured: During the study period (4 weeks)
Resident behavior after OT exposure
Resident behavior after OT exposure. Observation of the care team.
Measured: During the study period (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start16 Sep 2024
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia AlzheimersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel-arm trial.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé Afonso, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396377
- Sponsor's protocol ID
- RBHP 2023 MARTIN
- Other IDs
- 2023-A00383-42
- Acronym
- PROTMA
- Status last verified
- Dec 2024
- First submitted
- 5 Apr 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06396377
- Acronym / sponsor ID
- PROTMA / RBHP 2023 MARTIN
- Conditions
- Dementia Alzheimers
- Keywords
- Alzheimer, Reborn doll, agitation, behavioural disorders, cognitive disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized parallel-arm trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Reborn doll (Therapeutic object - OT)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Resident or representative refusing to participate
- Resident under judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reborn doll (Therapeutic object - OT)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. | Device | Reborn doll |
Primary outcome
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.
7 secondary outcomes
Factors that can affect doll benefits: gender, age, pathology, Charlson Comorbidity Index, doll identifier.
Time frame: Inclusion
Drug treatments
Time frame: During the study period (4 weeks)
Average exposure time to Reborn®dolls
Time frame: During the study period (4 weeks)
Therapeutic evaluation scale
Time frame: During the study period (4 weeks)
Quality of working life questionnaire
Time frame: During the study period (4 weeks)
Resident behavior following OT withdrawal
Time frame: During the study period (4 weeks)
Resident behavior after OT exposure
Time frame: During the study period (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloé Afonso principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reborn doll (Therapeutic object - OT) in people with Dementia Alzheimers, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of resident agitation using the Cohen Mansfield scale (time frame: During the study period (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.