Clinical trial NCT05567965: Live Better at Home in Catalonia
Official title: Live Better at Home (Catalonia): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Geriatrics
Home Care Services
Keywords: Older people
Home care
Functional capacity
Dependence
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Spanish Society of Geriatrics and Gerontology
First posted: 2022-10-05
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The intensity of the home care interventions for dependent older people offered in Spain, and specifically in Catalonia, may not be sufficient to help keep older people at home and delay institutionalisation in a nursing home, but an intensification of the intervention could improve the health and psychosocial state of dependent people and their informal caregivers and facilitate their permanence at home.

Detailed description: According to recent surveys, more than 80% of older people prefer to live at home, so the current model of care should aim to prolong the autonomy of older people so that they remain as long as possible at home and delay their entry into nursing homes.

The hypothesis of the study is that an intensification of the home care intervention in users with degree II or III of dependency will delay or avoid their institutionalisation in nursing homes.

The main aim of the study is to evaluate the effect of an intensification in home care interventions on users with grade II or III dependency in order to delay or avoid their institutionalisation in a geriatric residence.

Secondary aims are to analyse the effect of an intensification of home care interventions in users with degree II or III of dependency on their health and psychosocial state.To analyse the effect of an intensification of home care intervention together with training for informal caregivers on the health status and overburden of informal caregivers of users with degree II or III of dependency.

To test the impact on the use of resources of an intensification of home care interventions in users with degree II or III of dependency.

A randomised clinical trial with two parallel arms and blinded assessment will be conducted. The duration of follow-up will be 18 months. It will be carried out at the community level in homes in eight municipalities in the province of Barcelona, Catalonia (Spain).

Eligibility criteria: Inclusion Criteria:

* Older people (men and women aged 65 and over).
* Living in the community.
* Categorized with a degree II or III of dependency.
* Users of the public home care without requesting admission to an institution in Catalonia.
* With a main informal caregiver in charge.
* The acceptance to participate in the study of the user and the informal caregiver.

Exclusion Criteria:

* Users with privately paid professional carers.
* Users in palliative care (short life expectancy).

Primary outcomes:
measure: Change in time from baseline until application for nursing home admission
timeFrame: Every month up to 18 months. Assessed from the baseline in the study until the application for entry in nursing home, assessed up to 18 months.
Secondary outcomes:
measure: Functional capacity
timeFrame: Every 3 months up to 18 months.
measure: Frailty
timeFrame: Every 3 months up to 18 months.
measure: Risk of sarcopenia
timeFrame: Every 3 months up to 18 months.
measure: Risk of falls
timeFrame: Every 3 months up to 18 months.
measure: Cognitive status
timeFrame: Every 3 months up to 18 months.
measure: Social network
timeFrame: Every 3 months up to 18 months.
measure: Chronic patient experience
timeFrame: Every 3 months up to 18 months.
measure: Quality of life related with health
timeFrame: Every 1 month up to 18 months.
Other outcomes:
measure: Physical activity grade
timeFrame: Every 3 months up to 18 months.
measure: Caregiver overburden
timeFrame: Every 3 months up to 18 months.
measure: Experience of the informal caregiver with people with chronic disease
timeFrame: Every 3 months up to 18 months.
Locations:
Study officials:
affiliation: Spanish Society of Geriatrics and Gerontology
name: Jose Augusto Garcia Navarro
role: PRINCIPAL_INVESTIGATOR
References: