KASEHPAD: KArukera Study of Aging in Nursing Homes

Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04587466
Collaborator
Agence Régionale de Santé de la Guadeloupe (Other)
500
11
24
45.5
1.9

Study Details

Study Description

Brief Summary

Nursing homes are a recent occurrence in Guadeloupe, and little is known about the characteristics of their residents. In Guadeloupe, in the French West Indies, nearly 1200 dependent older people are cared for in nursing homes. The aim of the KArukera Study of Aging in Nursing Homes (KASEHPAD) is to study the care pathways of dependent elderly people in nursing homes in Guadeloupe over a year. The main objective will be to obtain the annual rate of hospitalisation in this setting. The secondary objectives will be to assess hospitalisations costs, the incidence of mortality, the prevalence of geriatric syndromes, as well as the quality of life of residents and professional caregiver burnout. Ultimately, these results will be compared to a similar study in nursing homes, the KASAF study (for Karukera Study of Aging in Foster Families).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    hile not fully integrated in the Caribbean culture, nursing homes may well become a necessity, and their number is growing. For example, there are now 6 nursing homes in Jamaica, and since the first one in 1991, 20 more have opened in Guadeloupe. Being admitted in a nursing home may be beneficial for the residents as well as for their families since it offers around-the-clock medical care and a secure living environment. On the other hand, living in a nursing home also tend to alter the medical and psychological state of the resident. Little is known about the characteristics of nursing home residents in Guadeloupe. Epidemiological and medico-economic data on older people in nursing homes are essential to assess the relevance of this type of care, and several and yet unanswered questions come to mind: what is the residents' annual hospitalization rate and the associated costs? What is the prevalence of geriatric syndromes in this population, and the incidence of mortality? What is the incidence of pneumonia, the leading cause of death and emergency hospitalization in older people? What is the quality of life of the older residents and their professional caregivers? KASEHPAD, an epidemiological cohort, aims to answer these questions. This longitudinal study will assess the health status and medical and economic data of 500 nursing home residents and their professional caregivers over a year. A similar study (KASAF, for Karukera Study of Aging in Foster Families) will be conducted simultaneously among 250 older people in foster families, as to compare these two types of care.

    The main outcome is the number of hospitalizations over a year. Local PMSI (Medicalization program of the information system) hospitals databases will provide information on hospital admissions.

    500 people aged 60 and older and living in nursing homes in Guadeloupe will be included. Data collection will be conducted using face-to-face interviews with the participants and their professional caregivers at baseline and after 6 and 12 months, and phone interviews with the professional caregivers, after 3 and 9 months. Anthropometric measures, information on general health status and care pathways (hospitalization, medical and paramedical consultations), as well as data on medical history, cognition, nutritional status, and physical frailty will also be collected. Depressive and anxiety symptoms will also be assessed along with functional abilities (mobility, instrumental activities of daily living and activities of daily living). A systematic update of vital status (death) and care pathway will be carried out at each follow-up. Additional information on the residents' living status and potential hospitalizations will be collected after 3 and 9 months. Finally, professional caregivers will be interviewed at inclusion, after 6 months and after a year to assess their own quality of life and burnout symptoms.

    This study was supported by a grant from the Agence Régionale de Santé de la Guadeloupe.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Cohort Study of the Care Pathway for Elderly People in Care in Nursing Homes in Guadeloupe
    Actual Study Start Date :
    Nov 3, 2020
    Anticipated Primary Completion Date :
    May 3, 2021
    Anticipated Study Completion Date :
    Nov 3, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Hospitalization rate of the participant [12 months]

      Number of hospital admissions over a year, retrieved from the local PMSI (Medicalization program of the information system) of the Hospital Center of Guadeloupe

    Secondary Outcome Measures

    1. Length of hospital stays of the participant [12 months]

      Length of hospital stays expressed as number of days and nights, retrieved from the local PMSI (Medicalization program of the information system) of the Hospital Center of Guadeloupe

    Other Outcome Measures

    1. Medical consultations of the participant [inclusion]

      Number of consultations with a general practitioner, a medical specialist or paramedical professional will be collected. This information will be retrieved from the CRF using the RUD-Lite scale (Resource Utilization in Dementia questionnaire). This scale assesses the use of healthcare resources by people suffering from dementia. The professional caregiver will complete this questionnaire at inclusion.

    2. Medical consultations of the participant [3 months]

      Number of consultations with a general practitioner, a medical specialist or paramedical professional will be collected. This information will be retrieved from the CRF using the RUD-Lite scale (Resource Utilization in Dementia questionnaire). This scale assesses the use of healthcare resources by people suffering from dementia. The professional caregiver will complete this questionnaire at the 3-month follow-up.

    3. Medical consultations of the participant [6 months]

      Number of consultations with a general practitioner, a medical specialist or paramedical professional will be collected. This information will be retrieved from the CRF using the RUD-Lite scale (Resource Utilization in Dementia questionnaire). This scale assesses the use of healthcare resources by people suffering from dementia. The professional caregiver will complete this questionnaire at the 6-month follow-up.

    4. Medical consultations of the participant [9 months]

      Number of consultations with a general practitioner, a medical specialist or paramedical professional will be collected. This information will be retrieved from the CRF using the RUD-Lite scale (Resource Utilization in Dementia questionnaire). This scale assesses the use of healthcare resources by people suffering from dementia. The professional caregiver will complete this questionnaire at the 9-month follow-up.

    5. Medical consultations of the participant [12 months]

      Number of consultations with a general practitioner, a medical specialist or paramedical professional will be collected. This information will be retrieved from the CRF using the RUD-Lite scale (Resource Utilization in Dementia questionnaire). This scale assesses the use of healthcare resources by people suffering from dementia. The professional caregiver will complete this questionnaire at the 12-month follow-up.

    6. Global cost of hospitalization of the participant [12 months]

      Global cost of hospitalization will be retrieved from the local PMSI (Medicalization program of the information system) databases after study completion

    7. Vital status of the participant [3 months]

      Vital status (alive or deceased) will be collected at the 3-month follow-up from the professional caregiver.

    8. Vital status of the participant [6 months]

      Vital status (alive or deceased) will be collected at the 6-month follow-up from the professional caregiver.

    9. Vital status of the participant [9 months]

      Vital status (alive or deceased) will be collected at the 9-month follow-up , from the professional caregiver.

    10. Vital status of the participant [12 months]

      Vital status (alive or deceased) will be collected at the 12-month follow-up , from the professional caregiver.

    11. Lower respiratory tract infections of the participant [inclusion]

      Occurrence of lower respiratory tract infections will be collected using the RUD-lite. For the diagnosis of lower respiratory tract infections, at least two of the following must be present and a doctor must confirm the clinical evidence: Cough (starting or worsening) that may produce phlegm, specific clinical signs during auscultation; Fever. (≥38°C); Chest pain ; Rapid, shallow breathing ((≥25 per minute) ; Confusion or increased dependency. The professional caregiver will complete this question at inclusion.

    12. Lower respiratory tract infections of the participant [3 months]

      Occurrence of lower respiratory tract infections will be collected using the RUD-lite. For the diagnosis of lower respiratory tract infections, at least two of the following must be present and a doctor must confirm the clinical evidence: Cough (starting or worsening) that may produce phlegm, specific clinical signs during auscultation; Fever. (≥38°C); Chest pain ; Rapid, shallow breathing ((≥25 per minute) ; Confusion or increased dependency. The professional caregiver will complete this question at the 3-month follow-up.

    13. Lower respiratory tract infections of the participant [6 months]

      Occurrence of lower respiratory tract infections will be collected using the RUD-lite. For the diagnosis of lower respiratory tract infections, at least two of the following must be present and a doctor must confirm the clinical evidence: Cough (starting or worsening) that may produce phlegm, specific clinical signs during auscultation; Fever. (≥38°C); Chest pain ; Rapid, shallow breathing ((≥25 per minute) ; Confusion or increased dependency. The professional caregiver will complete this question at the 6-month follow-up.

    14. Lower respiratory tract infections of the participant [9 months]

      Occurrence of lower respiratory tract infections will be collected using the RUD-lite. For the diagnosis of lower respiratory tract infections, at least two of the following must be present and a doctor must confirm the clinical evidence: Cough (starting or worsening) that may produce phlegm, specific clinical signs during auscultation; Fever. (≥38°C); Chest pain ; Rapid, shallow breathing ((≥25 per minute) ; Confusion or increased dependency. The professional caregiver will complete this question at the 9-month follow-up.

    15. Lower respiratory tract infections of the participant [12 months]

      Occurrence of lower respiratory tract infections will be collected using the RUD-lite. For the diagnosis of lower respiratory tract infections, at least two of the following must be present and a doctor must confirm the clinical evidence: Cough (starting or worsening) that may produce phlegm, specific clinical signs during auscultation; Fever. (≥38°C); Chest pain ; Rapid, shallow breathing ((≥25 per minute) ; Confusion or increased dependency. The professional caregiver will complete this question at at the 12-month follow-up.

    16. Falls of the participant [6 months]

      Total number of falls since the last visit will be collected at the 6-month follow-up from the professional caregivers.

    17. Falls of the participant [12 months]

      Total number of falls since the last visit will be collected at the 12-month follow-up from the professional caregivers.

    18. Cognition of the participant [inclusion]

      The level of cognitive deterioration of the participants will be with the Mini Mental State Examination (MMSE). This 30-item scale assesses the severity of cognitive deterioration through items of orientation, learning, attention and arithmetic, memory, language, and constructive praxis. The scale is rated from 0 to 30, reflecting the level of cognitive impairment. The participant will complete this questionnaire at inclusion.

    19. Cognition of the participant [6 months]

      The level of cognitive deterioration of the participants will be with the Mini Mental State Examination (MMSE). This 30-item scale assesses the severity of cognitive deterioration through items of orientation, learning, attention and arithmetic, memory, language, and constructive praxis. The scale is rated from 0 to 30, reflecting the level of cognitive impairment. The participant will complete this questionnaire at the 6-month follow-up.

    20. Cognition of the participant [12 months]

      The level of cognitive deterioration of the participants will be with the Mini Mental State Examination (MMSE). This 30-item scale assesses the severity of cognitive deterioration through items of orientation, learning, attention and arithmetic, memory, language, and constructive praxis. The scale is rated from 0 to 30, reflecting the level of cognitive impairment. The participant will complete this questionnaire at the 12-month follow-up.

    21. Depressive symptoms of the participant [inclusion]

      Depressive symptoms will be assessed using the CES-D (Center for Epidemiologic Studies- Depression Scale validated in French by Fuhrer & Rouillon This 20-item questionnaire assesses depressive symptomatology, including 4 items on positive affect (happiness, self-worth, confidence, enjoyment). Frequency of symptom occurrence during the past week is assessed by the participant using a 4-point Likert scale ("never", "occasionally", "quite often" and "frequently"). The score ranges from 0 to 60. The higher the score, the more significant the symptomatology. Data will be collected at inclusion, T6 and T12. For statistical analyses, the variable will be dichotomized (1 = presence of depression and 0 = absence of depression). The participant will complete this questionnaire at inclusion.

    22. Depressive symptoms of the participant [6 months]

      Depressive symptoms will be assessed using the CES-D (Center for Epidemiologic Studies- Depression Scale validated in French by Fuhrer & Rouillon This 20-item questionnaire assesses depressive symptomatology, including 4 items on positive affect (happiness, self-worth, confidence, enjoyment). Frequency of symptom occurrence during the past week is assessed by the participant using a 4-point Likert scale ("never", "occasionally", "quite often" and "frequently"). The score ranges from 0 to 60. The higher the score, the more significant the symptomatology. Data will be collected at inclusion, T6 and T12. For statistical analyses, the variable will be dichotomized (1 = presence of depression and 0 = absence of depression). The participant will complete this questionnaire at the 6-month follow-up

    23. Depressive symptoms of the participant [12 months]

      Depressive symptoms will be assessed using the CES-D (Center for Epidemiologic Studies- Depression Scale validated in French by Fuhrer & Rouillon This 20-item questionnaire assesses depressive symptomatology, including 4 items on positive affect (happiness, self-worth, confidence, enjoyment). Frequency of symptom occurrence during the past week is assessed by the participant using a 4-point Likert scale ("never", "occasionally", "quite often" and "frequently"). The score ranges from 0 to 60. The higher the score, the more significant the symptomatology. Data will be collected at inclusion, T6 and T12. For statistical analyses, the variable will be dichotomized (1 = presence of depression and 0 = absence of depression). The participant will complete this questionnaire at the 12-month follow-up.

    24. Feeling of loneliness of the participant [inclusion]

      Feeling of loneliness will be captured with the 14th item of the CES-D (14, 15): " I felt lonely ". The participant will complete this test at inclusion.

    25. Feeling of loneliness of the participant [6 months]

      Feeling of loneliness will be captured with the 14th item of the CES-D (14, 15): " I felt lonely ". The participant will complete this test at the 6-month follow-up.

    26. Feeling of loneliness of the participant [12 months]

      Feeling of loneliness will be captured with the 14th item of the CES-D (14, 15): " I felt lonely ". The participant will complete this test at the 12-month follow-up.

    27. Polypharmacy of the participant [inclusion]

      Total number of medications taken by participants will be collected from the professional caregiver at inclusion to assess polypharmacy.

    28. Polypharmacy of the participant [6 months]

      Total number of medications taken by participants will be collected from the professional caregiver at the 6-month follow-up to assess polypharmacy.

    29. Polypharmacy of the participant [12 months]

      Total number of medications taken by participants will be collected from the professional caregiver at the 12-month follow-up to assess polypharmacy.

    30. Malnutrition of the participant [inclusion]

      Malnutrition will be assessed with the short version of the Mini Nutritional Assessment (18). This questionnaire assesses nutritional status. A score under 12 indicates probable undernutrition. For the analyses, the variable will be dichotomized accordingly (1 = undernutrition; 0 = no undernutrition). The participant will complete this questionnaire at inclusion.

    31. Malnutrition of the participant [6 months]

      Malnutrition will be assessed with the short version of the Mini Nutritional Assessment (18). This questionnaire assesses nutritional status. A score under 12 indicates probable undernutrition. For the analyses, the variable will be dichotomized accordingly (1 = undernutrition; 0 = no undernutrition). The participant will complete this questionnaire at the 6-month follow-up.

    32. Malnutrition of the participant [12 months]

      Malnutrition will be assessed with the short version of the Mini Nutritional Assessment (18). This questionnaire assesses nutritional status. A score under 12 indicates probable undernutrition. For the analyses, the variable will be dichotomized accordingly (1 = undernutrition; 0 = no undernutrition). The participant will complete this questionnaire at the 12-month follow-up.

    33. Sarcopenia of the participant [inclusion]

      The Short Physical Performance Battery (SPPB) will help to identify sarcopenia. Three subtests measure lower-extremity functions: keeping balance (feet side-by-side, semi-tandem, tandem balance position, to be kept for 10 seconds each), walking 4 meters at usual pace, yielding a gait speed ratio (meter per second) ; standing up and sitting down five times as quickly as possible with the arms folded. Each movement is scored 0-4 points out of a total score from 0 to 12, with higher scores showing better physical performance. If total score is under 8, there is a risk of sarcopenia. For the analyses, the variable will be dichotomized accordingly (1 = sarcopenia; 0 = no sarcopenia). The participant will complete this test at inclusion.

    34. Sarcopenia of the participant [6 months]

      The Short Physical Performance Battery (SPPB) will help to identify sarcopenia. Three subtests measure lower-extremity functions: keeping balance (feet side-by-side, semi-tandem, tandem balance position, to be kept for 10 seconds each), walking 4 meters at usual pace, yielding a gait speed ratio (meter per second) ; standing up and sitting down five times as quickly as possible with the arms folded. Each movement is scored 0-4 points out of a total score from 0 to 12, with higher scores showing better physical performance. If total score is under 8, there is a risk of sarcopenia. For the analyses, the variable will be dichotomized accordingly (1 = sarcopenia; 0 = no sarcopenia). The participant will complete this test at the 6-month follow-up.

    35. Sarcopenia of the participant [12 months]

      The Short Physical Performance Battery (SPPB) will help to identify sarcopenia. Three subtests measure lower-extremity functions: keeping balance (feet side-by-side, semi-tandem, tandem balance position, to be kept for 10 seconds each), walking 4 meters at usual pace, yielding a gait speed ratio (meter per second) ; standing up and sitting down five times as quickly as possible with the arms folded. Each movement is scored 0-4 points out of a total score from 0 to 12, with higher scores showing better physical performance. If total score is under 8, there is a risk of sarcopenia. For the analyses, the variable will be dichotomized accordingly (1 = sarcopenia; 0 = no sarcopenia). The participant will complete this test at the 12-month follow-up.

    36. Frailty of the participant [inclusion]

      Frailty will be assessed at inclusion, T6 and T12 using Fried's phenotype (weight loss, exhaustion, low physical activity, slowness, weakness) and will be analyzed as a dichotomous variable, i.e. 1 = Fragile and 0 = Not Fragile. Information on the different components of the phenotype will be retrieved from the MNA, the SPPB and a hand-grip strength test using a dynamometer, at inclusion.

    37. Frailty of the participant [6 months]

      Frailty will be assessed at inclusion, T6 and T12 using Fried's phenotype (weight loss, exhaustion, low physical activity, slowness, weakness) and will be analyzed as a dichotomous variable, i.e. 1 = Fragile and 0 = Not Fragile. Information on the different components of the phenotype will be retrieved from the MNA, the SPPB and a hand-grip strength test using a dynamometer, at the 6-month follow-up.

    38. Frailty of the participant [12 months]

      Frailty will be assessed at inclusion, T6 and T12 using Fried's phenotype (weight loss, exhaustion, low physical activity, slowness, weakness) and will be analyzed as a dichotomous variable, i.e. 1 = Fragile and 0 = Not Fragile. Information on the different components of the phenotype will be retrieved from the MNA, the SPPB and a hand-grip strength test using a dynamometer, at the 12-month follow-up.

    39. Sensory impairment of the participant [inclusion]

      Sensory impairments (audition and vision) will be addressed by directly asking the professional caregiver. Variables will be dichotomized accordingly ((1 = hearing / vision impairment; 0 = hearing / vision impairment). The professional caregiver will complete this questionnaire at inclusion.

    40. Sensory impairment of the participant [6 months]

      Sensory impairments (audition and vision) will be addressed by directly asking the professional caregiver. Variables will be dichotomized accordingly ((1 = hearing / vision impairment; 0 = hearing / vision impairment). The professional caregiver will complete this questionnaire at the 6-month follow-up.

    41. Sensory impairment of the participant [12 months]

      Sensory impairments (audition and vision) will be addressed by directly asking the professional caregiver. Variables will be dichotomized accordingly ((1 = hearing / vision impairment; 0 = hearing / vision impairment). TThe professional caregiver will complete this questionnaire at the 12-month follow-up.

    42. Activities of Daily Living of the participant [inclusion]

      The level of independence in Activities of Daily Living (ADL) and incontinence will be assessed using the Katz's scale, a 6-item scale assessing independence in 6 basic activities of daily living: bathing, toileting, eating, dressing, incontinence. For each activity, a score of 1 indicates complete autonomy, a score of 0.5 indicates partial autonomy, and a score of 0 indicates complete dependency. The professional caregiver will complete this questionnaire about the participant at inclusion.

    43. Activities of Daily Living of the participant [6 months]

      The level of independence in Activities of Daily Living (ADL) and incontinence will be assessed using the Katz's scale, a 6-item scale assessing independence in 6 basic activities of daily living: bathing, toileting, eating, dressing, incontinence. For each activity, a score of 1 indicates complete autonomy, a score of 0.5 indicates partial autonomy, and a score of 0 indicates complete dependency. The professional caregiver will complete this questionnaire about the participant at the 6-month follow-up.

    44. Activities of Daily Living of the participant [12 months]

      The level of independence in Activities of Daily Living (ADL) and incontinence will be assessed using the Katz's scale, a 6-item scale assessing independence in 6 basic activities of daily living: bathing, toileting, eating, dressing, incontinence. For each activity, a score of 1 indicates complete autonomy, a score of 0.5 indicates partial autonomy, and a score of 0 indicates complete dependency. The professional caregiver will complete this questionnaire about the participant at the 12-month follow-up.

    45. Instrumental Activities of Daily Living of the participant [inclusion]

      The level of independence in Instrumental Activities of Daily Living (IADL) will be assessed using Lawton's IADL scale. The professional caregiver will complete this questionnaire about the participant at inclusion.

    46. Instrumental Activities of Daily Living of the participant [6 months]

      The level of independence in Instrumental Activities of Daily Living (IADL) will be assessed using Lawton's IADL scale. The professional caregiver will complete this questionnaire about the participant at the 6-month follow-up.

    47. Instrumental Activities of Daily Living of the participant [12 months]

      The level of independence in Instrumental Activities of Daily Living (IADL) will be assessed using Lawton's IADL scale. The professional caregiver will complete this questionnaire about the participant at the 12-month follow-up.

    48. Dependency of the participant [inclusion]

      In France, the AGGIR questionnaire has been developed by public authorities to quickly assess the degree of dependency of elderly people, and assign a dependency group, ranging from 0 (bedridden, completely dependent) to 6 (no help required, the person is autonomous in everyday activities.) This scale is routinely completed by every nursing home at admission and updated when necessary to reassess healthcare pathways. The professional caregiver will complete this questionnaire about the participant at inclusion.

    49. Dependency of the participant [6 months]

      In France, the AGGIR questionnaire has been developed by public authorities to quickly assess the degree of dependency of elderly people, and assign a dependency group, ranging from 0 (bedridden, completely dependent) to 6 (no help required, the person is autonomous in everyday activities.) This scale is routinely completed by every nursing home at admission and updated when necessary to reassess healthcare pathways. The professional caregiver will complete this questionnaire about the participant at the 6-month follow-up.

    50. Dependency of the participant [12 months]

      In France, the AGGIR questionnaire has been developed by public authorities to quickly assess the degree of dependency of elderly people, and assign a dependency group, ranging from 0 (bedridden, completely dependent) to 6 (no help required, the person is autonomous in everyday activities.) This scale is routinely completed by every nursing home at admission and updated when necessary to reassess healthcare pathways. The professional caregiver will complete this questionnaire about the participant at at the 12-month follow-up.

    51. Psychological and Behavioral Symptoms in Dementia of the participant [inclusion]

      Psychological and Behavioral Symptoms in Dementia will be assessed with the short version of the NeuroPsychiatric Inventory or NPI. This scale assesses presence, severity for the patient and impact on the professional's workload of an array of psychological and behavioral manifestations (agitation, hallucinations, apathy, etc.) as well as neurovegetative symptoms (sleep and appetite). The professional caregiver will complete this questionnaire about the participant at inclusion.

    52. Psychological and Behavioral Symptoms in Dementia of the participant [6 months]

      Psychological and Behavioral Symptoms in Dementia will be assessed with the short version of the NeuroPsychiatric Inventory or NPI. This scale assesses presence, severity for the patient and impact on the professional's workload of an array of psychological and behavioral manifestations (agitation, hallucinations, apathy, etc.) as well as neurovegetative symptoms (sleep and appetite). The professional caregiver will complete this questionnaire about the participant at the 6-month follow-up.

    53. Psychological and Behavioral Symptoms in Dementia of the participant [12 months]

      Psychological and Behavioral Symptoms in Dementia will be assessed with the short version of the NeuroPsychiatric Inventory or NPI. This scale assesses presence, severity for the patient and impact on the professional's workload of an array of psychological and behavioral manifestations (agitation, hallucinations, apathy, etc.) as well as neurovegetative symptoms (sleep and appetite). The professional caregiver will complete this questionnaire about the participant at the 12-month follow-up.

    54. Risk of developing pressure ulcers of the participant [inclusion]

      Risk of developing pressure ulcers will be assessed with the Braden's Scale, and pressure ulcers will be classified according to the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. The professional caregiver will complete this questionnaire about the participant at inclusion.

    55. Risk of developing pressure ulcers of the participant [6 months]

      Risk of developing pressure ulcers will be assessed with the Braden's Scale, and pressure ulcers will be classified according to the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. The professional caregiver will complete this questionnaire about the participant at the 6-month follow-up.

    56. Risk of developing pressure ulcers of the participant [12 months]

      Risk of developing pressure ulcers will be assessed with the Braden's Scale, and pressure ulcers will be classified according to the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. The professional caregiver will complete this questionnaire about the participant at the 12-month follow-up.

    57. Quality of life of the participant [inclusion]

      Quality of life of the participant will be assessed using the QoL-AD (Questionnaire Quality of Life - Alzheimer's Disease). This 13-item questionnaire assesses the participant's physical condition, mood, relationships with friends and family, financial difficulties, and overall quality of life. The self-rated and the proxy-rated version of the questionnaire will be administered to the participant and the caregiver, respectively. The items are evaluated using a 4-point ordinal scale ranging from poor to excellent, with a total score ranging from 13 to 52. For the weighted score, the participant's score is multiplied by 2, the caregiver's score (about the participant's quality of life) is added, and the total is divided by 3 to bring the score back to the initial scale. The participant and the professional caregiver will complete this test at inclusion.

    58. Quality of life of the participant [6 months]

      Quality of life of the participant will be assessed using the QoL-AD (Questionnaire Quality of Life - Alzheimer's Disease). This 13-item questionnaire assesses the participant's physical condition, mood, relationships with friends and family, financial difficulties, and overall quality of life. The self-rated and the proxy-rated version of the questionnaire will be administered to the participant and the caregiver, respectively. The items are evaluated using a 4-point ordinal scale ranging from poor to excellent, with a total score ranging from 13 to 52. For the weighted score, the participant's score is multiplied by 2, the caregiver's score (about the participant's quality of life) is added, and the total is divided by 3 to bring the score back to the initial scale. The participant and the professional caregiver will complete this test at the 6-month follow-up.

    59. Quality of life of the participant [12 months]

      Quality of life of the participant will be assessed using the QoL-AD (Questionnaire Quality of Life - Alzheimer's Disease). This 13-item questionnaire assesses the participant's physical condition, mood, relationships with friends and family, financial difficulties, and overall quality of life. The self-rated and the proxy-rated version of the questionnaire will be administered to the participant and the caregiver, respectively. The items are evaluated using a 4-point ordinal scale ranging from poor to excellent, with a total score ranging from 13 to 52. For the weighted score, the participant's score is multiplied by 2, the caregiver's score (about the participant's quality of life) is added, and the total is divided by 3 to bring the score back to the initial scale. The participant and the professional caregiver will complete this test at the 12-month follow-up.

    60. Health-related quality of life of the participant [inclusion]

      Health-related quality of life of the participant will be assessed with the EQ-5D questionnaire. This questionnaire assesses health conditions. It is the most widely used questionnaire in medico-economic analyses. It allows health outcomes to be assessed in terms of QALYs (Quality-Adjusted Life-Years). This indicator summarizes the length and quality of life in a single figure. The result of a cost-utility analysis is expressed in terms of the cost of gaining one QALY (i.e. one year lived in perfect health). To estimate QALY, health-related quality of life is designed on a continuum from 0 (death) to 1 (perfect health). Each health status is thus assigned a weight of 0 to 1, the higher the corresponding quality of life. The participant and the foster caregiver will complete this test at inclusion.

    61. Health-related quality of life of the participant [6 months]

      Health-related quality of life of the participant will be assessed with the EQ-5D questionnaire. This questionnaire assesses health conditions. It is the most widely used questionnaire in medico-economic analyses. It allows health outcomes to be assessed in terms of QALYs (Quality-Adjusted Life-Years). This indicator summarizes the length and quality of life in a single figure. The result of a cost-utility analysis is expressed in terms of the cost of gaining one QALY (i.e. one year lived in perfect health). To estimate QALY, health-related quality of life is designed on a continuum from 0 (death) to 1 (perfect health). Each health status is thus assigned a weight of 0 to 1, the higher the corresponding quality of life. The participant and the foster caregiver will complete this test at the 6-month follow-up.

    62. Health-related quality of life of the participant [12 months]

      Health-related quality of life of the participant will be assessed with the EQ-5D questionnaire. This questionnaire assesses health conditions. It is the most widely used questionnaire in medico-economic analyses. It allows health outcomes to be assessed in terms of QALYs (Quality-Adjusted Life-Years). This indicator summarizes the length and quality of life in a single figure. The result of a cost-utility analysis is expressed in terms of the cost of gaining one QALY (i.e. one year lived in perfect health). To estimate QALY, health-related quality of life is designed on a continuum from 0 (death) to 1 (perfect health). Each health status is thus assigned a weight of 0 to 1, the higher the corresponding quality of life. The participant and the foster caregiver will complete this test at the 12-month follow-up.

    63. Adaptation to the nursing home of the participant [inclusion]

      Adaptation to the professional family will be assessed using Castonguay & Ferron's scale. This is a 17-item scale designed to identify people who have difficulties to adjust to nursing home life. The participants must answer "yes" or "no" to a series of statements about their daily life and habits in the residence. A score of 16 or 17 indicates a good general adaptation, while a score of 11 or less indicates significant difficulties. The participant and the professional caregiver will complete this test at inclusion.

    64. Adaptation to the nursing home of the participant [6 months]

      Adaptation to the professional family will be assessed using Castonguay & Ferron's scale. This is a 17-item scale designed to identify people who have difficulties to adjust to nursing home life. The participants must answer "yes" or "no" to a series of statements about their daily life and habits in the residence. A score of 16 or 17 indicates a good general adaptation, while a score of 11 or less indicates significant difficulties. The participant and the professional caregiver will complete this test at the 6-month follow-up.

    65. Adaptation to the nursing home of the participant [12 months]

      Adaptation to the professional family will be assessed using Castonguay & Ferron's scale. This is a 17-item scale designed to identify people who have difficulties to adjust to nursing home life. The participants must answer "yes" or "no" to a series of statements about their daily life and habits in the residence. A score of 16 or 17 indicates a good general adaptation, while a score of 11 or less indicates significant difficulties. The participant and the professional caregiver will complete this test at the 12-month follow-up.

    66. Professional caregivers' quality of life assessed with SF-36 [inclusion]

      Professional caregivers' quality of life will be assessed with the Medical Outcomes Study Short-Form General Health Survey - 36 items (SF-36, a widely validated health-related quality of life questionnaire, that uses questions on physical, social and psychological domains. The professional caregiver will complete this questionnaire at inclusion.

    67. Professional caregivers' quality of life assessed with SF-36 [6 months]

      Professional caregivers' quality of life will be assessed with the Medical Outcomes Study Short-Form General Health Survey - 36 items (SF-36, a widely validated health-related quality of life questionnaire, that uses questions on physical, social and psychological domains. The professional caregiver will complete this questionnaire at the 6-month follow-up.

    68. Professional caregivers' quality of life assessed with SF-36 [12 months]

      Professional caregivers' quality of life will be assessed with the Medical Outcomes Study Short-Form General Health Survey - 36 items (SF-36, a widely validated health-related quality of life questionnaire, that uses questions on physical, social and psychological domains. The professional caregiver will complete this questionnaire at the 12-month follow-up.

    69. Professional caregivers' quality of life assessed with the Pro-QoL scale [inclusion]

      Symptoms of burnout will be assessed with the Pro-QoL scale (professional quality of life scale). This 30-item questionnaire yields three domain-specific scores: burnout risk, compassion, and compassion fatigue. The professional caregiver will complete this questionnaire at inclusion.

    70. Professional caregivers' quality of life assessed with the Pro-QoL scale [6 months]

      Symptoms of burnout will be assessed with the Pro-QoL scale (professional quality of life scale). This 30-item questionnaire yields three domain-specific scores: burnout risk, compassion, and compassion fatigue. The professional caregiver will complete this questionnaire at the 6-month follow-up.

    71. Professional caregivers' quality of life assessed with the Pro-QoL scale [12 months]

      Symptoms of burnout will be assessed with the Pro-QoL scale (professional quality of life scale). This 30-item questionnaire yields three domain-specific scores: burnout risk, compassion, and compassion fatigue. The professional caregiver will complete this questionnaire at the 12-month follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • participant must be over 60 years old

    • residents must live in a nursing home in Guadeloupe, Saint-Martin or Saint-Barthelemy

    • residents must benefit from the French social security

    • Participant must have an identified support person

    • Participant under guardianship or curatorship if accepted by the legal guardian

    • Participant in a foreseeable short-term end-of-life situation if accepted by the legal representative or the support person

    Exclusion Criteria:
    • refusal from the resident or his legal guardian to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ehpad Residence Sacré Cœur Basse-Terre Guadeloupe 97100
    2 Ehpad Kalana Bouillante Guadeloupe 97125
    3 Ehpad Nou Gran Moun Capesterre-Belle-Eau Guadeloupe 97130
    4 Ehpad Residence Senior 'Les Flamboyants' Gourbeyre Guadeloupe
    5 Ehpad St-Christophe Grand-Bourg Guadeloupe 97112
    6 Ehpad Domaine de Choisy Le gosier Guadeloupe 97190
    7 Ehpad Ch Jacques Salin Les Abymes Guadeloupe 97139
    8 Ehpad Les Jardins de Belost Saint-Claude Guadeloupe 97120
    9 Ehpad Res. Medico-Sle de Marie-Galante Saint-Louis Guadeloupe 97134
    10 Ehpad Les Roses de Lima Sainte-Rose Guadeloupe 97115
    11 Ehpad Bethany Home Saint Martin Saint Martin 97150

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Pointe-a-Pitre
    • Agence Régionale de Santé de la Guadeloupe

    Investigators

    • Principal Investigator: Maturin MT TABUE-TEGUO, MD MhD, CHU de la Guadeloupe

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Pointe-a-Pitre
    ClinicalTrials.gov Identifier:
    NCT04587466
    Other Study ID Numbers:
    • PAP_RIPH3_2020/04
    • 2020-A00960-39
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Pointe-a-Pitre
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2021