- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06121778
Home Support for Elderly: Evaluation of Intra- Extrinsic Determinants Which Maximize This Possibility (MADMAX)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yoshimasa SAGAWA, PhD
- Phone Number: +33381662390
- Email: yoshimasa.sagawa@univ-fcomte.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Home
Elderly people living at home
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/7111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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