Clinical trial NCT05729906: Dynamic Predictions of the Links Between Psychological and Physical Health of Older Patients in Nursing Home
Official title: Dynamic Predictions of the Links Between Psychological and Physical Health of Older Patients in Nursing Home Via the Integration of "Multi-omics" Data.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Health
Physical Health
Keywords: mental health
physical health
psychosomatic model
disability model
inflammation
metabolomics
nursing home
frailty
inflamm'aging
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Research Center for Respiratory Diseases, Inserm U1100
First posted: 2023-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older persons over 65 in nursing homes

Brief summary: Taking the older person as a whole is now essential to age well and prevent loss of functional independence. However, the relationship between physical and mental health remains not well understood. Combining the exploration of markers of inflammation, endocrine, nutritional, and metabolic functions, along with long-term monitoring of older persons, could allow for a comprehensive understanding of the biological phenotype, regardless of underlying pathologies. The primary objective will be to simultaneously test the psychosomatic model and the disability model in order to more fully account for the dynamic causal relationships between physical and mental health in older people. The investigators will investigate the mediating role of the biological phenotype on these relationships between mental and physical health. The independent and then combined analysis of specific candidate biomarkers will open up the possibility of identifying a biological mediation between mental and physical health. Furthermore, this will also allow us to deepen our understanding of the evolution of the immune-endocrine-metabolic state and, more broadly, of the biological phenotype of older people during aging.

Detailed description: Promoting the health of older people to better support them remains one of the major challenges of the 21st century. More and more experts in gerontology (doctors, psychologists, sociologists, ...) are now advocating a holistic approach to older people. The recent recommendations of the WHO (2016) also invite us to favor an approach to aging centered on the potentialities and resources of older people more than on their deficiencies and diseases. Thus, taking into account the older person in his or her entirety ("body and mind") is a must for aging well and preventing the loss of functional independence. However, the relationship between physical and mental health remains poorly understood.

The psychosomatic model postulates that well-being and positive affects have an impact on physical health. It has thus been shown that good psychological health (e.g., positive mood, hope, optimism) has long-term beneficial effects on longevity, cardiovascular health, and chronic diseases. Conversely, poor mental health (e.g., presence of depressive symptoms) affects the health of older subjects and increases mortality risk. These results are in line with the so-called top-down approaches which postulate that well-being is a psychological trait that is the cause of future personal evaluations. In this psychosomatic approach, well-being, positive affect (i.e., good psychological health), is seen as antecedent to physical health. Naturally, it would seem unlikely that well-being would predict improved health for older people. However, well-being or the presence of positive affect could well predict different trajectories of "health" in ill older people.

In contrast, the so-called disability model postulates that physical health problems have an impact on psychological health, including well-being. This bottom-up approach considers physical health problems as antecedents of well-being. A study conducted by members of the laboratory supporting this project argues for this approach. The results show that poor physical health would unidirectionally predict poor life satisfaction over the long term.However, no study to date has been able to confirm the prevalence of one model over the other.

The main hypothesis of this research is based on the presence of a bi-directional pattern between physical and psychological health, and thus on the absence of a unique prevalence of one pattern over the other for the entire target elderly population. The investigators also hypothesize that the causal links between physical and psychological health may vary over time as a function of specific mediators, including inflammatory and metabolomic profiles. Our second hypothesis thus postulates that biological profiles could mediate the bi-directional links between physical and psychological health. For example, the investigators know that negative psychological affects have a negative impact on our "physical" health, so the investigators can assume that positive psychological affects can produce an anti-inflammatory effect, thus allowing us to be in better physical health (protective factor).

Eligibility criteria: Inclusion Criteria:

Institutionalized older adults over 65

Exclusion Criteria:

* older adults in palliative care
* older adults with severe cognitive impairment (MMSE \<11)
* Opposition to data processing from the older adult or his/her guardian/trustee if under legal protection

Primary outcomes:
measure: PANAS
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: PHQ-9
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: Subjective Age Rating Scale
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: EVIBE (psychological)
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: MMSE
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: SPPB
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: EVIBE (physical)
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: Diagnosis of undernutrition
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: MNA
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: Charlson score
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: CIRS
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: ADLS
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
measure: CFS
timeFrame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.
Secondary outcomes:
measure: inflammatory measures
timeFrame: T0: inclusion visit, T1: month 6 and T2: month 12
measure: metabolomic profiles
timeFrame: T0: inclusion visit, T1: month 6 and T2: month 12
Other outcomes:
Locations:
city: Chateau-Renault
country: France
facility: EHPAD CHIC Amboise/Chateau-Renault
city: Chinon
country: France
facility: EHPAD Les Groussins
city: Loches
country: France
facility: EHPAD Paul Martinais
city: Luynes
country: France
facility: EHPAD Le Clos Mignot
city: Tours
country: France
facility: EHPAD l'Ermitage
Study officials:
affiliation: CHRU de Tours
name: Wassim GANA
role: PRINCIPAL_INVESTIGATOR
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