Elderly Clinical Trial
— RISING-DOMOfficial title:
Impact of an Assessment of Risk Factors for Falls and Personalized Care, on Mortality and Institutionalization, After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home
Verified date | May 2024 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this project, the investigators are interested in a particular population, that of elderly subjects who used the SAMU after a fall and who are not hospitalized or are hospitalized less than 24 hours. The scientific literature concerning this population is poor . However, this is a particularly vulnerable population. The Direction of research, studies, evaluation and statistics (DREES) report notes that in 2005 in metropolitan France, 24% of people aged 65 to 75 said they had fallen in the last 12 months. Home falls among seniors may require emergency medical services (EMS).
Status | Completed |
Enrollment | 952 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - Living at home - Living at maximum 45 minutes from a hospital center participating in the study (for logistical reasons and practices of study organization) - Intervention of the SAMU for a fall at home without there being hospitalization or with hospitalization lasting less than 24h - Patient or trusted person capable of giving telephone information - Patient or his / her trusted person who has agreed to participate in the study - Patient affiliated to a social security scheme Exclusion Criteria: - Total dependency (ADL at 0) - Entry in nursing home already scheduled within 3 months |
Country | Name | City | State |
---|---|---|---|
France | CH Albi | Albi | |
France | CH Cahors | Cahors | |
France | CH Castres-Mazamet | Castres | |
France | CHIVA | Foix | |
France | CH Lannemezan | Lannemezan | |
France | CH Lavaur | Lavaur | |
France | CH Montauban | Montauban | |
France | CH Rodez | Rodez | |
France | CH Ariège Couserans | Saint-Girons | |
France | CH Bigorre | Tarbes | |
France | University Hospital Toulouse | Toulouse | |
France | Maison de Santé Pluri-professionnelle | Vic-Fezensac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Ailliaud A, Moulis E, Vaysset S, Berbon C, Tavassoli N, Bouzid W, Oliveira Soares C, Qassemi S, Nourashemi F. [Assessment in the home of the elderly following a first fall with Samu intervention]. Soins Gerontol. 2022 Jan-Feb;27(153):23-25. doi: 10.1016/j.sger.2021.11.008. Epub 2021 Nov 24. French. — View Citation
Bouzid W, Tavassoli N, Berbon C, Qassemi S, Bounes V, Azema O, Shourick J, Nourhashemi F. Impact of a personalised care plan for the elderly calling emergency medical services after a fall at home: The RISING-DOM multi-centre randomised controlled trial protocol. BMC Geriatr. 2022 Mar 4;22(1):182. doi: 10.1186/s12877-022-02850-w. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The delay between the T0 and Time of occurrence | The composite criterion corresponding to the delay between the T0 and the occurrence of an institutionalization or a death before institutionalization (first event occurring).
In this pilot study, the average age of subjects was 83.6 years. This is a population for which the goals of home care and delay in the onset of dependence and in the occurrence of death are interesting and feasible. |
2 years | |
Secondary | Number of reminders to the SAMU for fall | The average number of SAMU recalls for drop during the follow-up period will be compared between the two groups at 12 and 24 months after inclusion. This data is collected from a regional database of regulatory data in partnership with the Regional Health Agency (ARS) for all subjects included. | 2 years | |
Secondary | Number of non-programmed hospitalizations | Hospitalizations will be collected for all patients included during the follow-up. We will compare more specifically the unplanned hospitalizations: the average number of unplanned hospitalizations will be compared between the two groups at 12 and 24 months of follow-up.
This data is collected during the unannounced semi-annual telephone call of the subjects' home groups. |
2 years | |
Secondary | Evolution of the dependence level evaluated by the ADL scale | Katz's scale of functional independence for activities of daily living (Katz S, 1963), commonly known as Katz's ADL (Katz Activity of Living Living Scale), is the most appropriate tool for assessing functional abilities. basic patient. Clinicians generally use this tool to detect problems with performing 6 basic activities of daily living and to plan care accordingly. The score varies from 0 (completely dependent) to 6 (completely autonomous). A score of 4 indicates a moderate functional deficit and 2 a severe functional deficit. | 2 years | |
Secondary | Evolution of the quality-of-life score evaluated by Short Form -12 | The investigators will use the Short Form-12 Quality of Life Scale, which is an abbreviated version of the Medical Outcomes Study Short-Form General Health Survey, with only 12 of the 36 questions that can save a lot of time. It is a generic questionnaire that makes it possible to compare groups of subjects with different pathologies. It measures eight aspects of quality of life that reflect
World Health Organization (WHO) definition of quality of life: general and mental health, physical and social functioning, physical and emotional health, pain and vitality. Compared to the Short Form-36, the Short Form-12 has the advantage of being shorter, less time-consuming, thus easier for the evaluator and better tolerated by patients. Its results are correlated with those of the Short Form-36. The Short Form-12 allows to obtain two scores (between 0 and 100, calculated thanks to an algorithm): a score of quality of mental and social life and a physical quality of life score. |
2 years | |
Secondary | Number of deceased or institutionalized subjects | The number of deceased or institutionalized subjects during the follow-up period will be compared between the two groups at 12 and at 24 months of follow-up. This data is collected in both groups during the unannounced semiannual telephone call of the groups belonging to the subjects. | 2 years |
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