Clinical trial NCT04587466: KArukera Study of Aging in Nursing Homes
Official title: Prospective Cohort Study of the Care Pathway for Elderly People in Care in Nursing Homes in Guadeloupe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Geriatric Syndromes
Keywords: Older people
nursing home
hospitalization
geriatric syndromes
mortality
quality of life
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
Collaborators: name: Agence Régionale de Santé de la Guadeloupe
First posted: 2020-10-14
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization rate of the participant
timeFrame: 12 months
Secondary outcomes:
measure: Length of hospital stays of the participant
timeFrame: 12 months
Other outcomes:
measure: Medical consultations of the participant
timeFrame: inclusion
measure: Medical consultations of the participant
timeFrame: 3 months
measure: Medical consultations of the participant
timeFrame: 6 months
measure: Medical consultations of the participant
timeFrame: 9 months
measure: Medical consultations of the participant
timeFrame: 12 months
measure: Global cost of hospitalization of the participant
timeFrame: 12 months
measure: Vital status of the participant
timeFrame: 3 months
measure: Vital status of the participant
timeFrame: 6 months
measure: Vital status of the participant
timeFrame: 9 months
measure: Vital status of the participant
timeFrame: 12 months
measure: Lower respiratory tract infections of the participant
timeFrame: inclusion
measure: Lower respiratory tract infections of the participant
timeFrame: 3 months
measure: Lower respiratory tract infections of the participant
timeFrame: 6 months
measure: Lower respiratory tract infections of the participant
timeFrame: 9 months
measure: Lower respiratory tract infections of the participant
timeFrame: 12 months
measure: Falls of the participant
timeFrame: 6 months
measure: Falls of the participant
timeFrame: 12 months
measure: Cognition of the participant
timeFrame: inclusion
measure: Cognition of the participant
timeFrame: 6 months
measure: Cognition of the participant
timeFrame: 12 months
measure: Depressive symptoms of the participant
timeFrame: inclusion
measure: Depressive symptoms of the participant
timeFrame: 6 months
measure: Depressive symptoms of the participant
timeFrame: 12 months
measure: Feeling of loneliness of the participant
timeFrame: inclusion
measure: Feeling of loneliness of the participant
timeFrame: 6 months
measure: Feeling of loneliness of the participant
timeFrame: 12 months
measure: Polypharmacy of the participant
timeFrame: inclusion
measure: Polypharmacy of the participant
timeFrame: 6 months
measure: Polypharmacy of the participant
timeFrame: 12 months
measure: Malnutrition of the participant
timeFrame: inclusion
measure: Malnutrition of the participant
timeFrame: 6 months
measure: Malnutrition of the participant
timeFrame: 12 months
measure: Sarcopenia of the participant
timeFrame: inclusion
measure: Sarcopenia of the participant
timeFrame: 6 months
measure: Sarcopenia of the participant
timeFrame: 12 months
measure: Frailty of the participant
timeFrame: inclusion
measure: Frailty of the participant
timeFrame: 6 months
measure: Frailty of the participant
timeFrame: 12 months
measure: Sensory impairment of the participant
timeFrame: inclusion
measure: Sensory impairment of the participant
timeFrame: 6 months
measure: Sensory impairment of the participant
timeFrame: 12 months
measure: Activities of Daily Living of the participant
timeFrame: inclusion
measure: Activities of Daily Living of the participant
timeFrame: 6 months
measure: Activities of Daily Living of the participant
timeFrame: 12 months
measure: Instrumental Activities of Daily Living of the participant
timeFrame: inclusion
measure: Instrumental Activities of Daily Living of the participant
timeFrame: 6 months
measure: Instrumental Activities of Daily Living of the participant
timeFrame: 12 months
measure: Dependency of the participant
timeFrame: inclusion
measure: Dependency of the participant
timeFrame: 6 months
measure: Dependency of the participant
timeFrame: 12 months
measure: Psychological and Behavioral Symptoms in Dementia of the participant
timeFrame: inclusion
measure: Psychological and Behavioral Symptoms in Dementia of the participant
timeFrame: 6 months
measure: Psychological and Behavioral Symptoms in Dementia of the participant
timeFrame: 12 months
measure: Risk of developing pressure ulcers of the participant
timeFrame: inclusion
measure: Risk of developing pressure ulcers of the participant
timeFrame: 6 months
measure: Risk of developing pressure ulcers of the participant
timeFrame: 12 months
measure: Quality of life of the participant
timeFrame: inclusion
measure: Quality of life of the participant
timeFrame: 6 months
measure: Quality of life of the participant
timeFrame: 12 months
measure: Health-related quality of life of the participant
timeFrame: inclusion
measure: Health-related quality of life of the participant
timeFrame: 6 months
measure: Health-related quality of life of the participant
timeFrame: 12 months
measure: Adaptation to the nursing home of the participant
timeFrame: inclusion
measure: Adaptation to the nursing home of the participant
timeFrame: 6 months
measure: Adaptation to the nursing home of the participant
timeFrame: 12 months
measure: Professional caregivers' quality of life assessed with SF-36
timeFrame: inclusion
measure: Professional caregivers' quality of life assessed with SF-36
timeFrame: 6 months
measure: Professional caregivers' quality of life assessed with SF-36
timeFrame: 12 months
measure: Professional caregivers' quality of life assessed with the Pro-QoL scale
timeFrame: inclusion
measure: Professional caregivers' quality of life assessed with the Pro-QoL scale
timeFrame: 6 months
measure: Professional caregivers' quality of life assessed with the Pro-QoL scale
timeFrame: 12 months
Locations:
city: Basse-Terre
country: Guadeloupe
facility: Ehpad Residence Sacré Cœur
city: Bouillante
country: Guadeloupe
facility: Ehpad Kalana
city: Capesterre-Belle-Eau
country: Guadeloupe
facility: Ehpad Nou Gran Moun
city: Gourbeyre
country: Guadeloupe
facility: Ehpad Residence Senior 'Les Flamboyants'
city: Grand-Bourg
country: Guadeloupe
facility: Ehpad St-Christophe
city: Le gosier
country: Guadeloupe
facility: Ehpad Domaine de Choisy
city: Les Abymes
country: Guadeloupe
facility: Ehpad Ch Jacques Salin
city: Saint-Claude
country: Guadeloupe
facility: Ehpad Les Jardins de Belost
city: Saint-Louis
country: Guadeloupe
facility: Ehpad Res. Medico-Sle de Marie-Galante
city: Sainte-Rose
country: Guadeloupe
facility: Ehpad Les Roses de Lima
city: Saint Martin
country: Saint Martin
facility: Ehpad Bethany Home
Study officials:
affiliation: CHU de la Guadeloupe
name: Maturin MT TABUE-TEGUO, MD MhD
role: PRINCIPAL_INVESTIGATOR
References: