BioMIND: Dynamic Predictions of the Links Between Psychological and Physical Health of Older Patients in Nursing Home

Sponsor

University Hospital, Tours (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05729906

Collaborator

iBrain, Inserm U1253 (Other), Research Center for Respiratory Diseases, Inserm U1100 (Other)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Health Physical Health	Other: psychological and physical tests

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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.

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Outcome Measures

Primary Outcome Measures

PANAS [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Positive and Negative Affect Schedule (PANAS) (Caci & Bayle, 2007) to evaluate positive and negative affects (20 items with a 5-point Likert scale; a score /50 for negative affects, a score/50 for positive affects). In order to adapt to the possible cognitive disorders of the participants, they will be asked to answer on a visual analogical scale using the same rating as the initial scale (scale from 1 to 5, from "very little or not at all" to "very much").
PHQ-9 [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001) for thymia (9 items, 4-point Likert scale with a maximum score of 27). In order to adapt to the participants' possible cognitive disorders, they will be asked to answer on a visual analog scale using the same rating as the initial scale (scale from 0 to 3, from "never" to "almost every day").
Subjective Age Rating Scale [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
Subjective Age Rating Scale (1 item) to evaluate perceived age.
EVIBE (psychological) [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Instant Well-Being Rating Scale (EVIBE) (Delphin-Combe et al., 2018) is a scale to evaluate subjective psychological well-being (1-5 visual analog scale, a higher score means a better outcome).
MMSE [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Mini-Mental State Examination (MMSE) (Folstein et al. 1975) for global cognitive status (score from 0 to 30 points, a higher score means a better outcome). In order to most closely match the participant's cognitive abilities at each data collection time, MMSE scores will only be collected from the medical records if they are less than 2 months old.
SPPB [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Short Physical Performance Battery test (SPPB) (Guralnik et al., 2000) for overall physical ability (3 sub-scores on 4 points each [walking, strength, balance], score from 0 to 12, a higher score means a better outcome)
EVIBE (physical) [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Instant Well-Being Rating Scale (EVIBE) (Delphin-Combe et al., 2018) for subjective physical well-being (visual analog scale from 1 to 5, a higher score means a better outcome)
Diagnosis of undernutrition [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The questionnaire for the diagnosis of undernutrition according to HAS criteria, allowing the presence and degree of undernutrition to be assessed (13 items, the diagnosis of undernutrition requires the presence of at least: 1 phenotypic criterion and 1 etiological criteria. Undernutrition is qualified as severe if one of the criteria of severe undernutrition is verified) (HAS, 2021)
MNA [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Mini Nutritional Assessment (MNA) (Guigoz et al., 2006) for the nutritional profile (6 screening items - score frome 0 to 14 points, a higher score means a worse outcome)
Charlson score [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Charlson score (Charlson et al., 1987) for the collection of comorbidities (calculation of an index weighted according to age, a higher score means a worse outcome)
CIRS [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Cumulative Illness Rating Scale (CIRS) (Parmelee et al., 1995) for the collection of comorbidities (14 items evaluated from "none" to "very severe", score from 0 to 56, a higher score means a worse outcome).
ADLS [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
Activities of Daily Living Scale (ADLS) (Katz & Akpom, 1976) for the level of functional autonomy (6 items, score from 0 to 6, a higher score means a better outcome).
CFS [Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.]
The Clinical Frailty Scale (CFS) (Abraham et al., 2019) for the evaluation of clinical frailty (only one item can be chosen, score from 1 to 9, a higher score means a worse outcome).

Secondary Outcome Measures

inflammatory measures [T0: inclusion visit, T1: month 6 and T2: month 12]
High Sensivity C-Reactive Protein (hsCRP) Interleukins (IL-6, other IL) and pro- and anti-inflammatory mediators Tumor Necrosis Factor-alpha (TNF-alpha) Orosomucoid Pre-albumin (Prognostic Inflammatory and Nutritional Index)
metabolomic profiles [T0: inclusion visit, T1: month 6 and T2: month 12]
Calculation of metabolite concentrations with metabolomic profile analyzed by high resolution mass spectrometry (LC/MS-MS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	EHPAD CHIC Amboise/Chateau-Renault	Chateau-Renault	France	37110
2	EHPAD Les Groussins	Chinon	France	37500
3	EHPAD Paul Martinais	Loches	France	37600
4	EHPAD Le Clos Mignot	Luynes	France	37230