Alzheimer DiseaseSensiCareNCT01819714
Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
A study testing Multi-sensory supportive care in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Multi-sensory supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent)
- The patient must be insured or beneficiary of a health insurance plan
- Alzheimer's-type neurodegenerative pathology
- The patient has been living in the participating center for > 2 months
Who cannot join
- The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent)
- It is impossible to correctly inform the patient's legal representative
- The patient has already has Snoezelen-therapy
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nîmes - Centre de Gérontologie de Serre Cavalier
Nîmes, 30029
About this study
Official title: Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.
Read the detailed description
The secondary objectives of this study are to study the following elements in relationship to the implementation of a "Snoezelen-type" multi-sensory care strategy for patients with Alzheimer's-type neurodegenerative disease:
- to evaluate the effects on NPI-Q scores at 1 month, 6 months and 12 months .
- evaluate the effects on quality of life (questionnaire QOL-AD) at 0 and 12 months.
- assess changes in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire over 0, 1, 3, 6 and 12 months.
- assess changes in drug consumption (anxiolytics, antidepressants, hypnotics, neuroleptics)over the study period
- Conditions
- Alzheimer Disease
- Being tested
- Multi-sensory supportive care
- Keywords
- Snoezelen, Multi-sensorial care session, Alzheimer's-type neurodegenerative disease, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-sensory supportive careOther
Also called Snoezelen-type care, Snoezelen toilette
The Serre-Cavalier center will implement Snoezelen-type multisensory care sessions for included patients; these care sessions correspond with the patients' daily hygiene/toilette care.
The impact of this multisensory strategy will be evaluated using a before-after design.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | Patients hospitalized at the Serre-Cavalier centre and who have Alzheimer's-type neurodegenerative disease (see inclusion criteria). Receives: Other: Multi-sensory supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NPI-Q scores
Measured: 3 months
Secondary outcomes (12)
Change from baseline in NPI-Q scores
Measured: 1 month
Change from baseline in NPI-Q scores
Measured: 6 months
Change from baseline in NPI-Q scores
Measured: 12 months
Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)
Measured: 12 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Measured: 1 month
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Measured: 3 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Measured: 6 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Measured: 12 months
Change in drug consumption from baseline
Measured: 1 month
Change in drug consumption from baseline
Measured: 3 months
Change in drug consumption from baseline
Measured: 6 months
Change in drug consumption from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Debuysschere, IDE, Study director, Centre Hospitalier Universitaire de NīmesJean-Marie Cros, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819714
- Sponsor's protocol ID
- PHRIP/2012/JD
- Other IDs
- 2013-A00005-40
- Acronym
- SensiCare
- Status last verified
- Apr 2015
- First submitted
- 25 Mar 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT01819714
- Acronym / sponsor ID
- SensiCare / PHRIP/2012/JD
- Conditions
- Alzheimer Disease
- Keywords
- Snoezelen, Multi-sensorial care session, Alzheimer's-type neurodegenerative disease, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Mar 2013 (estimated)
- 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 main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.
Detailed description
The secondary objectives of this study are to study the following elements in relationship to the implementation of a "Snoezelen-type" multi-sensory care strategy for patients with Alzheimer's-type neurodegenerative disease:
- to evaluate the effects on NPI-Q scores at 1 month, 6 months and 12 months .
- evaluate the effects on quality of life (questionnaire QOL-AD) at 0 and 12 months.
- assess changes in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire over 0, 1, 3, 6 and 12 months.
- assess changes in drug consumption (anxiolytics, antidepressants, hypnotics, neuroleptics)over the study period
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Other: Multi-sensory supportive carePatients hospitalized at the Serre-Cavalier centre and who have Alzheimer's-type neurodegenerative disease (see inclusion criteria). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent)
- The patient must be insured or beneficiary of a health insurance plan
- Alzheimer's-type neurodegenerative pathology
- The patient has been living in the participating center for > 2 months
Key exclusion criteria (3 listed)
- The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent)
- It is impossible to correctly inform the patient's legal representative
- The patient has already has Snoezelen-therapy
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 |
|---|---|---|
| Multi-sensory supportive careAlso: Snoezelen-type care, Snoezelen toiletteThe Serre-Cavalier center will implement Snoezelen-type multisensory care sessions for included patients; these care sessions correspond with the patients' daily hygiene/toilette care. The impact of this multisensory strategy will be evaluated using a before-after design. | Other | Study population |
Primary outcome
Change from baseline in NPI-Q scores
Time frame: 3 months
12 secondary outcomes
Change from baseline in NPI-Q scores
Time frame: 1 month
Change from baseline in NPI-Q scores
Time frame: 6 months
Change from baseline in NPI-Q scores
Time frame: 12 months
Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)
Time frame: 12 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time frame: 1 month
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time frame: 3 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time frame: 6 months
Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire
Time frame: 12 months
Change in drug consumption from baseline
Time frame: 1 month
Change in drug consumption from baseline
Time frame: 3 months
Change in drug consumption from baseline
Time frame: 6 months
Change in drug consumption from baseline
Time frame: 12 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 29 Apr 2015.
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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.
Jane Debuysschere, IDE study director
Centre Hospitalier Universitaire de Nīmes
Jean-Marie Cros, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-sensory supportive care in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 3 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 29 Apr 2015. 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?
Change from baseline in NPI-Q scores (time frame: 3 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 29 Apr 2015.