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

Physical Health Clinical Trial

— BioMIND  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05729906
• Other study ID #: DR220209-BioMIND
• Status: Active, not recruiting
• Start date: March 28, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Health
• Psychological Health

Intervention

Other:
• psychological and physical tests
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.

Locations

Country	Name	City	State
France	EHPAD CHIC Amboise/Chateau-Renault	Chateau-Renault
France	EHPAD Les Groussins	Chinon
France	EHPAD Paul Martinais	Loches
France	EHPAD Le Clos Mignot	Luynes
France	EHPAD l'Ermitage	Tours

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Tours	iBrain, Inserm U1253, Research Center for Respiratory Diseases, Inserm U1100

Country where clinical trial is conducted

France, 

References & Publications (18)

Abraham P, Courvoisier DS, Annweiler C, Lenoir C, Millien T, Dalmaz F, Flaatten H, Moreno R, Christensen S, de Lange DW, Guidet B, Bendjelid K, Walder B, Bollen Pinto B. Validation of the clinical frailty score (CFS) in French language. BMC Geriatr. 2019 Nov 21;19(1):322. doi: 10.1186/s12877-019-1315-8. — View Citation

Blazer DG, Hybels CF, Pieper CF. The association of depression and mortality in elderly persons: a case for multiple, independent pathways. J Gerontol A Biol Sci Med Sci. 2001 Aug;56(8):M505-9. doi: 10.1093/gerona/56.8.m505. — View Citation

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. — View Citation

Brief AP, Butcher AH, George JM, Link KE. Integrating bottom-up and top-down theories of subjective well-being: the case of health. J Pers Soc Psychol. 1993 Apr;64(4):646-53. doi: 10.1037//0022-3514.64.4.646. — View Citation

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.

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. — View Citation

Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of prospective observational studies. Psychosom Med. 2008 Sep;70(7):741-56. doi: 10.1097/PSY.0b013e31818105ba. Epub 2008 Aug 25. — View Citation

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. — View Citation

Diener E. Subjective well-being. Psychol Bull. 1984 May;95(3):542-75. No abstract available. — View Citation

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. — View Citation

Gan Y. Happy People Live Longer and Better: Advances in Research on Subjective Well-Being. Appl Psychol Health Well Being. 2020 Mar;12(1):3-6. doi: 10.1111/aphw.12192. Epub 2020 Jan 29. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hernandez R, Bassett SM, Boughton SW, Schuette SA, Shiu EW, Moskowitz JT. Psychological Well-being and Physical Health: Associations, Mechanisms, and Future Directions. Emot Rev. 2018 Jan;10(1):18-29. doi: 10.1177/1754073917697824. Epub 2017 Oct 20. — View Citation

Katz S, Akpom CA. A measure of primary sociobiological functions. Int J Health Serv. 1976;6(3):493-508. doi: 10.2190/UURL-2RYU-WRYD-EY3K. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	inflammatory measures	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)	T0: inclusion visit, T1: month 6 and T2: month 12
Secondary	metabolomic profiles	Calculation of metabolite concentrations with metabolomic profile analyzed by high resolution mass spectrometry (LC/MS-MS)	T0: inclusion visit, T1: month 6 and T2: month 12