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

NCT05729906 | Completed

• 1 other identifier: DR220209-BioMIND
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Psychological Health; Physical Health

Keywords

mental health; physical health; psychosomatic model; disability model; inflammation; metabolomics; nursing home; frailty; inflamm'aging

Outcome Measures

Primary Outcomes (13)

• PANAS

  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").

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• PHQ-9

  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").

  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

  Subjective Age Rating Scale (1 item) to evaluate perceived age.

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• EVIBE (psychological)

  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).

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• MMSE

  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.

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• SPPB

  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)

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• EVIBE (physical)

  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)

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• Diagnosis of undernutrition

  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)

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• MNA

  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)

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• Charlson score

  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)

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• CIRS

  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).

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• ADLS

  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).

  Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.

• CFS

  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).

  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 (2)

• inflammatory measures

  T0: inclusion visit, T1: month 6 and T2: month 12

• metabolomic profiles

  T0: inclusion visit, T1: month 6 and T2: month 12

Interventions

psychological and physical tests OTHER

Once included (T0), participants will be reviewed at 6 (T1), and 12 (T2) months. At the three measurement times, research professionals (belonging to the PAVeA laboratory) will carry out, within the nursing home the physical and psychological measurements (classic standardized tests for the population). These measurements will be carried out in parallel with the routine biological explorations performed in the institution. At each visit, the remaining blood sampled in routine will be frozen in 2 aliquots for metabolomic and spectrometric analyses at the end of the study by the iBrain and Research Center for Respiratory Diseases laboratories.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older persons over 65 in nursing homes

You may qualify if:

• Institutionalized older adults over 65

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Research Center for Respiratory Diseases, Inserm U1100: collaborator

Study Sites (5)

EHPAD CHIC Amboise/Chateau-Renault

Château-Renault, 37110, France

Location

EHPAD Les Groussins

Chinon, 37500, France

Location

EHPAD Paul Martinais

Loches, 37600, France

Location

EHPAD Le Clos Mignot

Luynes, 37230, France

Location

EHPAD l'Ermitage

Tours, 37000, France

Location

Related Publications (18)

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• Boehm JK, Kubzansky LD. The heart's content: the association between positive psychological well-being and cardiovascular health. Psychol Bull. 2012 Jul;138(4):655-91. doi: 10.1037/a0027448. Epub 2012 Apr 16.

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  PMID: 8473981 BACKGROUND

• Caci, H., & Baylé, F. (2007). L'échelle d'affectivité positive et d'affectivité négative. Première traduction en français. Présenté au Congrès de l'Encéphale, Paris, 22-25.

  BACKGROUND

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• Delphin-Combe F, Dauphinot V, Denormandie P, Sanchez S, Hay PE, Moutet C, Krolak-Salmon P. The Scale of instantaneous wellbeing: validity in a population with major neurocognitive disorders. Geriatr Psychol Neuropsychiatr Vieil. 2018 Sep 1;16(3):329-334. doi: 10.1684/pnv.2018.0745.

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• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Gana K, Bailly N, Saada Y, Joulain M, Trouillet R, Herve C, Alaphilippe D. Relationship between life satisfaction and physical health in older adults: a longitudinal test of cross-lagged and simultaneous effects. Health Psychol. 2013 Aug;32(8):896-904. doi: 10.1037/a0031656. Epub 2013 Mar 11.

  PMID: 23477581 BACKGROUND

• Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? J Nutr Health Aging. 2006 Nov-Dec;10(6):466-85; discussion 485-7.

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• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

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• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

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• Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc. 1995 Feb;43(2):130-7. doi: 10.1111/j.1532-5415.1995.tb06377.x.

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MeSH Terms

Conditions

Psychological Well-Being; Inflammation; Frailty

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wassim GANA

  CHRU de Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 15, 2023
• Study Start: March 28, 2023
• Primary Completion: September 28, 2023
• Study Completion: July 19, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

FR (5)