Behavioral DisorderPSYDOMANCT04573829
PsyDoMa : Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders
A study testing Home visit in people with Behavioral Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Behavioral Disorder
- What is being tested?
- Home visit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 19 Sep 2022
- 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
- For Patients
- Men or women over 65 years old showing signs of cognitive decline
- Living at home with specific needs ( meals, etc.) and the regular presence of a carer,
- Living in Nice
- Diagnosed with Alzheimer or dementia
- Presence of at least one behavioural disorder
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- Person who agreed and signed the informed consent or his/her guardian For Carers
- Carer of the patient who meets the inclusion criteria: spouse, children, siblings or other family members at home or a professional carer.
- Person involved during the motivational interviewing session regarding the psychoeducational program.
- Person who agreed and signed the informed consent.
Who cannot join
- For patients :
- Elderly person presenting no NINCDS- ADRDA criteria,
- Presence of sensory deficit (hearing or vision)
- Person unable to communicate,
- No regular presence of a home carer, waiting for a place in a nursing home
- Aging psychiatric pathologies,
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- Elderly person attending a day-care centre
- For carers :
- carer absent or not present enough,
- Elderly person with undiagnosed behavioural disorders
- Drug treatment that can interfere with assessments (psychotropic drugs, neuroleptics, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers
Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. The investigator will give them an informative leaflet and they will have to sign the consent form.
A diagnosis is made by the investigator. The patient will first have to undergo a neurocognitive assessment carried out at the Cimiez Hospital (test for the evaluation of a cognitive deficit) by a psychologist.
Read more
The non-drug approaches presented will be carried out directly at the participant's home with the help of the carer for therapeutic purposes.
The therapeutic objectives and the choice of approaches are specified within the Personalised Accompaniment Project (PAP).
The carer, if he or she wishes, participates in the sessions in order to reproduce the behaviours implemented by the psychologist.
Different workshops will be offered : Cooking, Art Therapy, Games, Multi-sensory, Soft Gymnastic, Relaxation, Music and Reminisence.
Patients will received three visits per week during six months. The carer will receive one visit per week for six months.
- Conditions
- Behavioral Disorder
- Being tested
- Home visit
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitProcedure or surgery
Psychologist come once a week for the carer and three times a week for the patient
| Study group | Role | What they receive |
|---|---|---|
| Non-drug approaches at home | Experimental | Non-drug approaches at home three visits per week during six months and psycho-education for the caregivers one time per week for six months. Receives: Procedure: Home visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of personalised care projects completed
Measured: at the end of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start14 Jan 2021
- Primary completion31 Mar 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Mederic Alzheimer
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, PU-PH, Principal investigator, Nice University Hospital, Gerontology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573829
- Sponsor's protocol ID
- 20-PP-19
- Acronym
- PSYDOMA
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers
- ClinicalTrials.gov ID
- NCT04573829
- Acronym / sponsor ID
- PSYDOMA / 20-PP-19
- Conditions
- Behavioral Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Fondation Mederic Alzheimer
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 5 Oct 2020 (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.
Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. The investigator will give them an informative leaflet and they will have to sign the consent form.
A diagnosis is made by the investigator. The patient will first have to undergo a neurocognitive assessment carried out at the Cimiez Hospital (test for the evaluation of a cognitive deficit) by a psychologist.
The non-drug approaches presented will be carried out directly at the participant's home with the help of the carer for therapeutic purposes.
The therapeutic objectives and the choice of approaches are specified within the Personalised Accompaniment Project (PAP).
The carer, if he or she wishes, participates in the sessions in order to reproduce the behaviours implemented by the psychologist.
Different workshops will be offered : Cooking, Art Therapy, Games, Multi-sensory, Soft Gymnastic, Relaxation, Music and Reminisence.
Patients will received three visits per week during six months. The carer will receive one visit per week for six months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-drug approaches at home | Experimental | Procedure: Home visitNon-drug approaches at home three visits per week during six months and psycho-education for the caregivers one time per week for six months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- For Patients
- Men or women over 65 years old showing signs of cognitive decline
- Living at home with specific needs ( meals, etc.) and the regular presence of a carer,
- Living in Nice
- Diagnosed with Alzheimer or dementia
Key exclusion criteria (11 listed)
- Elderly person presenting no NINCDS- ADRDA criteria,
- Presence of sensory deficit (hearing or vision)
- Person unable to communicate,
- No regular presence of a home carer, waiting for a place in a nursing home
- Aging psychiatric pathologies,
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 |
|---|---|---|
| Home visitPsychologist come once a week for the carer and three times a week for the patient | Procedure or surgery | Non-drug approaches at home |
Primary outcome
Ratio of personalised care projects completed
Time frame: at the end of 6 months
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 7 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Olivier GUERIN, PU-PH principal investigator
Nice University Hospital, Gerontology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visit in people with Behavioral Disorder, run by Centre Hospitalier Universitaire de Nice 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 10 inclusion and 11 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 7 Oct 2022. 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?
Ratio of personalised care projects completed (time frame: at the end of 6 months). 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 7 Oct 2022.