Psychological HealthBioMINDNCT05729906
Dynamic Predictions of the Links Between Psychological and Physical Health of Older Patients in Nursing Home
An observational study of Psychological Health and Physical Health, run by University Hospital, Tours at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Psychological Health, Physical Health
- What is being tested?
- psychological and physical tests
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 28 Mar 2023to 19 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older persons over 65 in nursing homes
Who may be able to join
- Institutionalized older adults over 65
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
EHPAD CHIC Amboise/Chateau-Renault
Château-Renault, 37110
EHPAD Les Groussins
Chinon, 37500
EHPAD Paul Martinais
Loches, 37600
EHPAD Le Clos Mignot
Luynes, 37230
EHPAD l'Ermitage
Tours, 37000
About this study
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.
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.
Read the 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).
- Conditions
- Psychological Health, Physical Health
- Being tested
- psychological and physical tests
- Keywords
- mental health, physical health, psychosomatic model, disability model, inflammation, metabolomics, nursing home, frailty, inflamm'aging
- Medical subject headings
- Psychological Well-Being, Inflammation, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological and physical testsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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").
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
- 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)
Measured: T0: inclusion visit, T1: month 6 and T2: month 12
metabolomic profiles
Calculation of metabolite concentrations with metabolomic profile analyzed by high resolution mass spectrometry (LC/MS-MS)
Measured: T0: inclusion visit, T1: month 6 and T2: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start28 Mar 2023
- Primary completion28 Sep 2023
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Psychological HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Research Center for Respiratory Diseases, Inserm U1100
- Responsible party
- Sponsor
- Investigators
- Wassim GANA, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729906
- Sponsor's protocol ID
- DR220209-BioMIND
- Acronym
- BioMIND
- Status last verified
- Dec 2024
- First submitted
- 20 Jan 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31752699Blazer 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.
PubMed 11487603Boehm 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.
PubMed 22506752Brief 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.
PubMed 8473981Caci, 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.
PubMed 3558716Chida 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.
PubMed 18725425Delphin-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.
PubMed 30168440Gan 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.
PubMed 31994837Diener E. Subjective well-being. Psychol Bull. 1984 May;95(3):542-75. No abstract available.
PubMed 6399758Folstein 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.
PubMed 1202204Gana 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.
PubMed 23477581Guigoz 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.
PubMed 17183419Guralnik 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.
PubMed 8126356Hernandez 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.
PubMed 36650890
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05729906
- Acronym / sponsor ID
- BioMIND / DR220209-BioMIND
- Conditions
- Psychological Health, Physical Health
- Keywords
- mental health, physical health, psychosomatic model, disability model, inflammation, metabolomics, nursing home, frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Research Center for Respiratory Diseases, Inserm U1100
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older persons over 65 in nursing homes
Key inclusion criteria (1 listed)
- Institutionalized older adults over 65
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological and physical testsOnce 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. | Other | – |
Primary outcome
PANAS
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
2 secondary outcomes
inflammatory measures
Time frame: T0: inclusion visit, T1: month 6 and T2: month 12
metabolomic profiles
Time frame: T0: inclusion visit, T1: month 6 and T2: month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 31752699Abraham 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.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wassim GANA principal investigator
CHRU de Tours
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Health and Physical Health, run by University Hospital, Tours at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANAS (time frame: Evolution over time of the psychological health (T1-T0, T2-T1, T2-T0). T0: inclusion visit, T1: month 6 and T2: month 12.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729906, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.