Dementia Alzheimers Clinical Trial
— PROTMAOfficial 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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Factors that can affect doll benefits: gender, age, pathology, Charlson Comorbidity Index, doll identifier. | Inclusion | ||
Secondary | Drug treatments | Medication during study period (name/posology) if applicable (daily record) | During the study period (4 weeks) | |
Secondary | Average exposure time to Reborn®dolls | Average exposure time to RebornĀ®dolls in minutes | During the study period (4 weeks) | |
Secondary | Therapeutic evaluation scale | Therapeutic evaluation grid only on days when residents are in possession of the OT on the Crossway computerized file | During the study period (4 weeks) | |
Secondary | 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). | During the study period (4 weeks) | |
Secondary | Resident behavior following OT withdrawal | Resident behavior following OT withdrawal (for experimental group). Observation of the care team. | During the study period (4 weeks) | |
Secondary | Resident behavior after OT exposure | Resident behavior after OT exposure. Observation of the care team. | During the study period (4 weeks) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT03378245 -
Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations
|
N/A | |
Recruiting |
NCT04871698 -
On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
|
||
Active, not recruiting |
NCT05847153 -
MASC: Reducing Stress for Caregivers
|
N/A | |
Recruiting |
NCT04863859 -
Persons With Dementia and Their Extended Family Caregivers
|
||
Active, not recruiting |
NCT05529277 -
Implementing Dementia Care Management Into Routine Care in the Region Siegen-Wittgenstein
|
||
Active, not recruiting |
NCT03631069 -
Detecting Dementia in the Retina Using Optical Coherence Tomography
|
||
Not yet recruiting |
NCT06047340 -
Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
N/A | |
Terminated |
NCT03682874 -
Identifying Novel Aging Targets for Treatment of Delirium
|
||
Completed |
NCT03907748 -
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
|
N/A | |
Completed |
NCT04058886 -
Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers
|
N/A | |
Not yet recruiting |
NCT05606445 -
Surface EMG to Measure Paratonia in Dementia
|
||
Recruiting |
NCT04308512 -
Care Coordination System for People With Dementia
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03943641 -
Dementia Risk Prediction Model: Development and Validation
|
||
Not yet recruiting |
NCT05245903 -
Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
|
||
Recruiting |
NCT03472482 -
Optical Coherence Tomography in Cerebral Amyloidosis
|
||
Recruiting |
NCT04313582 -
Feasibility of the SmartPrompt for Improving Everyday Function in Dementia
|
N/A | |
Recruiting |
NCT05315895 -
The Dampness Syndrome of Chinese Medicine Cohort Study
|
||
Completed |
NCT04462029 -
A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers
|
Early Phase 1 | |
Completed |
NCT04428112 -
Rural Dementia Caregiver Project
|
N/A |