Alzheimer DiseaseCOMPARSENCT01639586
Comparison for the Patient With Alzheimer Disease the Impact of Three Different Groups of Patient Care
A study testing respite platform, Day care and No access to a respite structure in people with Alzheimer Disease, run by Department of Clinical Research and Innovation at 1 site in France.
Trial summary
One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities. 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?
- respite platform, Day care and No access to a respite structure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Apr 2013
- 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
- patient affect by Alzheimer disease or related pathology
- patient with an informal caregiver
- patient not using any respite structure
- signed informed consent (patient and informal caregiver)
- affiliate to social security
Who cannot join
- patient without informal caregiver
- patient include in another clinical protocol
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison du Service Rendu à la Personne Atteinte d'Une Maladie d'Alzheimer et de l'Aidant Par Trois Types de Prises en Charge (Plateforme, Accueil de Jour et Groupe contrôle
One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities.
In the frame of non drug related approaches to Alzheimer disease (AD), several research projects and actions have already been conducted, but no specific study concerning the efficiency of different types of respite care structures have been conducted so far in France. The present project concerns the thematic of the frame "Development and diversification of respite care structures".
Read more
A platform is defined in the Alzheimer Plan as a "diversified range of despite structures according to patients' needs and informal caregivers' expectations" providing several objectives:
Two objectives targeting the informal caregivers:
- offer spare time or tutored
- inform, support and accompany
Two objectives targeting the patients:
- encourage maintain of the patient social life and relationships and work together towards his/her psychological and emotional well-being
- contribute to improve functional cognitive and sensory capacities
The study COMPARSE suggests to compare for the patient - informal caregiver couple, the impact of three different groups of patient care on health profit; resit platform (P), the day care group (D), the control group without access to a respite structure (C).
- Conditions
- Alzheimer Disease
- Being tested
- respite platform, Day care, No access to a respite structure
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respite platformBehavioural
Impact of the respite platform patient care on health profit
Day careBehavioural
Impact of the day care on health profit of patient
No access to a respite structureBehavioural
Control group without access to a respite structure
| Study group | Role | What they receive |
|---|---|---|
| D | Active comparator | Impact of the day care on health profit of patient Receives: Behavioral: Day care |
| C | Active comparator | No access to a respite structure Receives: Behavioral: No access to a respite structure |
| B | Active comparator | Respite platform Receives: Behavioral: respite platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the perceived and diagnosed health evolution of the patient
Realize neuropsychological evaluation and satisfaction degree evaluation of the patient and the informal caregiver to compare different types of respite care structures
Measured: at baseline, one month and nine month
Secondary outcomes (1)
Efficacity of the different structures
Assess autonomy level of patient Realize sociological qualitative analysis and economic evaluation by comparing differents structures
Measured: at baseline, one month and nine month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionApr 2013
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Clinical Research and Innovation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
- Investigators
- Christian Pradier, PHD MD, Principal investigator, Département de Santé Publique - CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639586
- Sponsor's protocol ID
- 2011-A00167-34
- Acronym
- COMPARSE
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2012
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison du Service Rendu à la Personne Atteinte d'Une Maladie d'Alzheimer et de l'Aidant Par Trois Types de Prises en Charge (Plateforme, Accueil de Jour et Groupe contrôle
- ClinicalTrials.gov ID
- NCT01639586
- Acronym / sponsor ID
- COMPARSE / 2011-A00167-34
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Department of Clinical Research and InnovationUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jul 2012 (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.
One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities.
In the frame of non drug related approaches to Alzheimer disease (AD), several research projects and actions have already been conducted, but no specific study concerning the efficiency of different types of respite care structures have been conducted so far in France. The present project concerns the thematic of the frame "Development and diversification of respite care structures".
A platform is defined in the Alzheimer Plan as a "diversified range of despite structures according to patients' needs and informal caregivers' expectations" providing several objectives:
Two objectives targeting the informal caregivers:
- offer spare time or tutored
- inform, support and accompany
Two objectives targeting the patients:
- encourage maintain of the patient social life and relationships and work together towards his/her psychological and emotional well-being
- contribute to improve functional cognitive and sensory capacities
The study COMPARSE suggests to compare for the patient - informal caregiver couple, the impact of three different groups of patient care on health profit; resit platform (P), the day care group (D), the control group without access to a respite structure (C).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D | Active comparator | Behavioral: Day careImpact of the day care on health profit of patient |
| C | Active comparator | Behavioral: No access to a respite structureNo access to a respite structure |
| B | Active comparator | Behavioral: respite platformRespite platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient affect by Alzheimer disease or related pathology
- patient with an informal caregiver
- patient not using any respite structure
- signed informed consent (patient and informal caregiver)
- affiliate to social security
Key exclusion criteria (3 listed)
- patient without informal caregiver
- patient include in another clinical protocol
- -
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 |
|---|---|---|
| respite platformImpact of the respite platform patient care on health profit | Behavioural | B |
| Day careImpact of the day care on health profit of patient | Behavioural | D |
| No access to a respite structureControl group without access to a respite structure | Behavioural | C |
Primary outcome
Analysis of the perceived and diagnosed health evolution of the patient
Time frame: at baseline, one month and nine month
Realize neuropsychological evaluation and satisfaction degree evaluation of the patient and the informal caregiver to compare different types of respite care structures
1 secondary outcome
Efficacity of the different structures
Time frame: at baseline, one month and nine month
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 22 Mar 2023.
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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.
Christian Pradier, PHD MD principal investigator
Département de Santé Publique - CHU de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respite platform, Day care and No access to a respite structure in people with Alzheimer Disease, run by Department of Clinical Research and Innovation 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 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 22 Mar 2023. 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?
Analysis of the perceived and diagnosed health evolution of the patient (time frame: at baseline, one month and nine month). 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 22 Mar 2023.