AgingMADMAXNCT06121778
Home Support for Elderly: Evaluation of Intra- Extrinsic Determinants Which Maximize This Possibility
An observational study of Aging and Functional Disturbance, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The French National Institute of Statistics and Economic Studies (INSEE) projects that the number of people aged 75 and over will increase in France from 5.2 million in 2007 to 11.6 million in 2060 (i.e., a 123% increase) and that of those aged 85 and over 1.3 to 5.4 million (315% increase). Read more about this study
- Who is it for?
- Ages 70 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Functional Disturbance, Home
- What is being tested?
- Home
- How many people
- 274 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 Oct 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Independent elderly people living in the region of Franche-Comté (France).
Who may be able to join
- Men and women living at home alone, as a couple or accompanied (children, relatives, etc.). For people living as a couple, if both meet all the criteria, both members of the couple can be evaluated; Being between 70 and 75 years old; Independent people physically capable of moving around (Iso Ressource Group [GIR] 5 and 6); GIR 5 includes people moving around alone within their home, eating and dressing alone. They may need occasional help with washing and domestic activities (meal preparation, cleaning, etc.); GIR 6 is made up of people who are autonomous for all discriminatory acts of everyday life. They may need occasional help with domestic activities; Living in a primary residence in Franche Comté region; Not objecting to participation in the study; Being affiliated to a French social security scheme or beneficiary of such a scheme.
Who cannot join
- Having made a request for living in an alternative hose or waiting for a response; Having an episode of acute pathology; Having major cognitive impairment (assessed using the Mini Mental State Examination [MMSE] and a threshold > 20 [mild or no impairment]) (23); Having a contraindication to physical exercise; Having artificial nutrition or having replacement treatment (e.g. dialysis); Being legally incapacitated or in limited legal capacity; Person unlikely to cooperate in the study and/or low cooperation anticipated by the investigator; Not expressing himself easily in French.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Maintien A Domicile de la Personne âgée : évaluation Des déterminants Intra- extrinsèques Qui MAXimisent Cette possibilité
The French National Institute of Statistics and Economic Studies (INSEE) projects that the number of people aged 75 and over will increase in France from 5.2 million in 2007 to 11.6 million in 2060 (i.e., a 123% increase) and that of those aged 85 and over 1.3 to 5.4 million (315% increase). The marked increase in this segment of the population poses numerous practical and ethical questions regarding adaptation to our society, particularly in terms of medico-social offers. More specifically, surveys carried out among French people show an important paradox: almost 90% of those questioned want to be able to age in their home, but at the same time only a small part (estimated at 6%) of the French homes is adapted to the aging of its population. This inconsistency places the question of housing at the center of current public policies.
If current societal concerns raise the question of need to find alternatives to entering an institution, a research work addressing all dimensions impacted by life at home for the elderly (quality of life, maintenance of functional, decision-making skills, nutritional status, etc.) jointly in the same population area and at different times (i.e., until leaving home for some people) remains to be carried out to allow us to better understand the nature and functioning of these factors, and thus propose integrated models. Indeed, too often these questions are studied separately on different populations and at different stages different from the life of the elderly person. Unfortunately, this does not allow us to clearly perceive the importance specificity takes on each factor, nor whether the proposals made really meet the objectives assigned to them. These questions relate in particular to: what aspects related to the person or their environment they contribute, when the person wishes, to be able to stay and live in your home? Since the departure of domicile would be postponed, does this mean that it is carried out due to the state health of the elderly worse? Understanding the relationship between the elderly and their housing will make it possible to draw up an inventory of the premises necessary for construction of the steps which will follow and which will be carried out by the different partners, in particular the public authorities, associations, social landlords (e.g., implementation of new clinical studies, health promotion, policy support, urban and housing planning, etc.). As part of an action-research program (concrete actions and transformative in the field), and relying on the approaches already underway, the main objective of this project will be to determine in elderly people living at home independent what are the main intrinsic factors and extrinsic elements that allow/promote this way of life.
- Conditions
- Aging, Functional Disturbance, Home
- Being tested
- Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeOther
There is no intervention but evaluations of elderly persons living at home will be conducted every three years and for the next 12 years. If some people leave the home, as far as possible, the reason will be asked.
| Study group | Role | What they receive |
|---|---|---|
| Home | Elderly people living at home Receives: Other: Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of elderly people remained at home (%)
To determine the percentage of elderly people who remained at home at the end of the project (after 12 years) and their characteristics.
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion31 Oct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121778
- Sponsor's protocol ID
- 2022/7111
- Acronym
- MADMAX
- Status last verified
- Jun 2023
- First submitted
- 27 Oct 2023
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintien A Domicile de la Personne âgée : évaluation Des déterminants Intra- extrinsèques Qui MAXimisent Cette possibilité
- ClinicalTrials.gov ID
- NCT06121778
- Acronym / sponsor ID
- MADMAX / 2022/7111
- Conditions
- Aging, Functional Disturbance, Home
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 31 Oct 2035 (estimated)
- First posted
- 8 Nov 2023 (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 French National Institute of Statistics and Economic Studies (INSEE) projects that the number of people aged 75 and over will increase in France from 5.2 million in 2007 to 11.6 million in 2060 (i.e., a 123% increase) and that of those aged 85 and over 1.3 to 5.4 million (315% increase). The marked increase in this segment of the population poses numerous practical and ethical questions regarding adaptation to our society, particularly in terms of medico-social offers. More specifically, surveys carried out among French people show an important paradox: almost 90% of those questioned want to be able to age in their home, but at the same time only a small part (estimated at 6%) of the French homes is adapted to the aging of its population. This inconsistency places the question of housing at the center of current public policies.
If current societal concerns raise the question of need to find alternatives to entering an institution, a research work addressing all dimensions impacted by life at home for the elderly (quality of life, maintenance of functional, decision-making skills, nutritional status, etc.) jointly in the same population area and at different times (i.e., until leaving home for some people) remains to be carried out to allow us to better understand the nature and functioning of these factors, and thus propose integrated models. Indeed, too often these questions are studied separately on different populations and at different stages different from the life of the elderly person. Unfortunately, this does not allow us to clearly perceive the importance specificity takes on each factor, nor whether the proposals made really meet the objectives assigned to them. These questions relate in particular to: what aspects related to the person or their environment they contribute, when the person wishes, to be able to stay and live in your home? Since the departure of domicile would be postponed, does this mean that it is carried out due to the state health of the elderly worse? Understanding the relationship between the elderly and their housing will make it possible to draw up an inventory of the premises necessary for construction of the steps which will follow and which will be carried out by the different partners, in particular the public authorities, associations, social landlords (e.g., implementation of new clinical studies, health promotion, policy support, urban and housing planning, etc.). As part of an action-research program (concrete actions and transformative in the field), and relying on the approaches already underway, the main objective of this project will be to determine in elderly people living at home independent what are the main intrinsic factors and extrinsic elements that allow/promote this way of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home | – | Other: HomeElderly people living at home |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Independent elderly people living in the region of Franche-Comté (France).
Key inclusion criteria (1 listed)
- Men and women living at home alone, as a couple or accompanied (children, relatives, etc.). For people living as a couple, if both meet all the criteria, both members of the couple can be evaluated; Being between 70 and 75 years old; Independent people physically capable of moving around (Iso Ressource Group [GIR] 5 and 6); GIR 5 includes people moving around alone within their home, eating and dressing alone. They may need occasional help with washing and domestic activities (meal preparation, cleaning, etc.); GIR 6 is made up of people who are autonomous for all discriminatory acts of everyday life. They may need occasional help with domestic activities; Living in a primary residence in Franche Comté region; Not objecting to participation in the study; Being affiliated to a French social security scheme or beneficiary of such a scheme.
Key exclusion criteria (1 listed)
- Having made a request for living in an alternative hose or waiting for a response; Having an episode of acute pathology; Having major cognitive impairment (assessed using the Mini Mental State Examination [MMSE] and a threshold > 20 [mild or no impairment]) (23); Having a contraindication to physical exercise; Having artificial nutrition or having replacement treatment (e.g. dialysis); Being legally incapacitated or in limited legal capacity; Person unlikely to cooperate in the study and/or low cooperation anticipated by the investigator; Not expressing himself easily in French.
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 |
|---|---|---|
| HomeThere is no intervention but evaluations of elderly persons living at home will be conducted every three years and for the next 12 years. If some people leave the home, as far as possible, the reason will be asked. | Other | Home |
Primary outcome
Percentage of elderly people remained at home (%)
Time frame: 12 years
To determine the percentage of elderly people who remained at home at the end of the project (after 12 years) and their characteristics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Functional Disturbance, run by Centre Hospitalier Universitaire de Besancon.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoshimasa SAGAWA, PhD (+33381662390, yoshimasa.sagawa@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of elderly people remained at home (%) (time frame: 12 years). 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 8 Nov 2023.