KArukera Study of Aging in Nursing Homes (KASEHPAD)

Prospective Cohort Study of the Care Pathway for Elderly People in Care in Nursing Homes in Guadeloupe

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).

Study Overview

• Status: Recruiting
• Conditions: Geriatric Syndromes

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Roxane RV VILLENEUVE, Ph. D; Phone Number: +590690403039; Email: roxane.villeneuve@chu-guadeloupe.fr
• Study Contact Backup: Name: Denis DB BOUCAUD-MAITRE, PhD; Phone Number: +59069006956377; Email: denis.boucaudmaitre@chu-guadeloupe.fr

Study Locations

• Guadeloupe
  • Basse-Terre, Guadeloupe, 97100
    • Not yet recruiting
    • Ehpad Residence Sacré Cœur
    • Contact: Séverine SA ADELAIDE, MD; Phone Number: +590590 60 88 20; Email: Severine.ADELAIDE@fondationpartageetvie.org
  • Bouillante, Guadeloupe, 97125
    • Recruiting
    • Ehpad Kalana
    • Contact: Claire HOUETTE, MD; Email: houette.c@manioukani.com
  • Capesterre-Belle-Eau, Guadeloupe, 97130
    • Not yet recruiting
    • Ehpad Nou Gran Moun
    • Contact: Simone Séjor-Pelis, MD; Email: simonepelis@hotmail.com
  • Gourbeyre, Guadeloupe
    • Recruiting
    • Ehpad Residence Senior 'Les Flamboyants'
    • Contact: Séverine Adélaide, MD; Phone Number: +5905 90 60 88 20; Email: Severine.ADELAIDE@fondationpartageetvie.org
  • Grand-Bourg, Guadeloupe, 97112
    • Not yet recruiting
    • Ehpad St-Christophe
    • Contact: Maryse ETZOL, MD; Email: marysetzol@gmail.com
  • Le gosier, Guadeloupe, 97190
    • Not yet recruiting
    • Ehpad Domaine de Choisy
    • Contact: karine fernandez, MD; Email: Dr.fernandez@choisy-cliniques.com
  • Les Abymes, Guadeloupe, 97139
    • Not yet recruiting
    • Ehpad Ch Jacques Salin
    • Contact: mariem alj, MD; Email: Mariem.alj@chgeront-gpe.fr
  • Saint-Claude, Guadeloupe, 97120
    • Not yet recruiting
    • Ehpad Les Jardins de Belost
    • Contact: Jean-Marie FAURE, MD; Email: Aaa.faure@wanadoo.fr
  • Saint-Louis, Guadeloupe, 97134
    • Not yet recruiting
    • Ehpad Res. Medico-Sle de Marie-Galante
    • Contact: Maturin Tabue-Teguo, MD PhD; Email: Maturin.tabueteguo@chu-guadeloupe.fr
  • Sainte-Rose, Guadeloupe, 97115
    • Not yet recruiting
    • Ehpad Les Roses de Lima
    • Contact: Franzt Ugolin, MD; Email: docteur.ugolin@wanadoo.fr
• Saint Martin
  • Saint Martin, Saint Martin, 97150
    • Not yet recruiting
    • Ehpad Bethany Home
    • Contact: Frédéric Olivo, MD; Email: frederic.olivo@esante-guadeloupe.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Every elderly person living in a nursing home in Guadeloupe will be invited to participate in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization rate of the participant	Number of hospital admissions over a year, retrieved from the local PMSI (Medicalization program of the information system) of the Hospital Center of Guadeloupe	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stays of the participant	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	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical consultations of the participant	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.	inclusion
Medical consultations of the participant	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 months
Medical consultations of the participant	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.	6 months
Medical consultations of the participant	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.	9 months
Medical consultations of the participant	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.	12 months
Global cost of hospitalization of the participant	Global cost of hospitalization will be retrieved from the local PMSI (Medicalization program of the information system) databases after study completion	12 months
Vital status of the participant	Vital status (alive or deceased) will be collected at the 3-month follow-up from the professional caregiver.	3 months
Vital status of the participant	Vital status (alive or deceased) will be collected at the 6-month follow-up from the professional caregiver.	6 months
Vital status of the participant	Vital status (alive or deceased) will be collected at the 9-month follow-up , from the professional caregiver.	9 months
Vital status of the participant	Vital status (alive or deceased) will be collected at the 12-month follow-up , from the professional caregiver.	12 months
Lower respiratory tract infections of the participant	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.	inclusion
Lower respiratory tract infections of the participant	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.	3 months
Lower respiratory tract infections of the participant	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.	6 months
Lower respiratory tract infections of the participant	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.	9 months
Lower respiratory tract infections of the participant	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.	12 months
Falls of the participant	Total number of falls since the last visit will be collected at the 6-month follow-up from the professional caregivers.	6 months
Falls of the participant	Total number of falls since the last visit will be collected at the 12-month follow-up from the professional caregivers.	12 months
Cognition of the participant	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.	inclusion
Cognition of the participant	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.	6 months
Cognition of the participant	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.	12 months
Depressive symptoms of the participant	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.	inclusion
Depressive symptoms of the participant	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	6 months
Depressive symptoms of the participant	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.	12 months
Feeling of loneliness of the participant	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.	inclusion
Feeling of loneliness of the participant	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.	6 months
Feeling of loneliness of the participant	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.	12 months
Polypharmacy of the participant	Total number of medications taken by participants will be collected from the professional caregiver at inclusion to assess polypharmacy.	inclusion
Polypharmacy of the participant	Total number of medications taken by participants will be collected from the professional caregiver at the 6-month follow-up to assess polypharmacy.	6 months
Polypharmacy of the participant	Total number of medications taken by participants will be collected from the professional caregiver at the 12-month follow-up to assess polypharmacy.	12 months
Malnutrition of the participant	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.	inclusion
Malnutrition of the participant	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.	6 months
Malnutrition of the participant	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.	12 months
Sarcopenia of the participant	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.	inclusion
Sarcopenia of the participant	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.	6 months
Sarcopenia of the participant	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.	12 months
Frailty of the participant	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.	inclusion
Frailty of the participant	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.	6 months
Frailty of the participant	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.	12 months
Sensory impairment of the participant	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.	inclusion
Sensory impairment of the participant	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.	6 months
Sensory impairment of the participant	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.	12 months
Activities of Daily Living of the participant	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.	inclusion
Activities of Daily Living of the participant	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.	6 months
Activities of Daily Living of the participant	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.	12 months
Instrumental Activities of Daily Living of the participant	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.	inclusion
Instrumental Activities of Daily Living of the participant	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.	6 months
Instrumental Activities of Daily Living of the participant	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.	12 months
Dependency of the participant	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.	inclusion
Dependency of the participant	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.	6 months
Dependency of the participant	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.	12 months
Psychological and Behavioral Symptoms in Dementia of the participant	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.	inclusion
Psychological and Behavioral Symptoms in Dementia of the participant	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.	6 months
Psychological and Behavioral Symptoms in Dementia of the participant	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.	12 months
Risk of developing pressure ulcers of the participant	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.	inclusion
Risk of developing pressure ulcers of the participant	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.	6 months
Risk of developing pressure ulcers of the participant	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.	12 months
Quality of life of the participant	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.	inclusion
Quality of life of the participant	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.	6 months
Quality of life of the participant	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.	12 months
Health-related quality of life of the participant	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.	inclusion
Health-related quality of life of the participant	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.	6 months
Health-related quality of life of the participant	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.	12 months
Adaptation to the nursing home of the participant	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.	inclusion
Adaptation to the nursing home of the participant	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.	6 months
Adaptation to the nursing home of the participant	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.	12 months
Professional caregivers' quality of life assessed with SF-36	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.	inclusion
Professional caregivers' quality of life assessed with SF-36	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.	6 months
Professional caregivers' quality of life assessed with SF-36	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.	12 months
Professional caregivers' quality of life assessed with the Pro-QoL scale	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.	inclusion
Professional caregivers' quality of life assessed with the Pro-QoL scale	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.	6 months
Professional caregivers' quality of life assessed with the Pro-QoL scale	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.	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Collaborators: Agence Régionale de Santé de la Guadeloupe
• Investigators: Principal Investigator: Maturin MT TABUE-TEGUO, MD MhD, CHU de la Guadeloupe

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Anticipated): May 3, 2021
• Study Completion (Anticipated): November 3, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; nursing home; mortality; hospitalization; Older people; geriatric syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: PAP_RIPH3_2020/04; 2020-A00960-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No