Live Better at Home in Catalonia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Live Better at Home (Catalonia): a Randomized Clinical Trial

Conditions
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Geriatrics, Home Care Services

Intervention / Treatment
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* Other: Home care intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensified home care intervention + Training<br>Users will receive an intensification in their home care intervention for dependence, receiving an intervention of a minimum of 1 hour per day and a maximum of 3.5 hours, to support their activities of daily living. The intensification will be personalised according to the specific needs of the user that the professionals consider necessary to attend. The weekly distribution of the intervention will be flexible in terms of timetables, as agreed between professional and informal caregivers. In addition, each informal caregiver will receive multimodal online training with the aim of providing knowledge, skills and attitudes that empower them to face the challenge of caring, guaranteeing quality care, preventing situations that may negatively affect both the person and the family dynamics and enabling an optimal evolution in caregiving. | Other: Home care intervention<br>* The duration of the intervention, both for the control group and the intervention group, will be 18 months or until the user's admission to the nursing home.<br>|
| Active Comparator: Conventional home care intervention<br>Participants will continue with their conventional home care intervention for dependence, comprising activities that are mainly carried out at the users' home and are oriented towards supporting their activities of daily living. This intervention is of personalised attention and its average intensity is about 20 minutes per day. | Other: Home care intervention<br>* The duration of the intervention, both for the control group and the intervention group, will be 18 months or until the user's admission to the nursing home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time from baseline until application for nursing home admission | To the user. Assessed by asking. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | To the user. Assessed by the Barthel Index. The scoring range is 0 (total dependency)-100 (slight dependency) | Every 3 months up to 18 months. | 
| Frailty | To the user. Assessed by the Frail-VIG index. The scoring range is 0 (no frailty)- 25 (advanced frailty). | Every 3 months up to 18 months. | 
| Risk of sarcopenia | To the user. Assessed by the strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. The scoring range is 0 - 10 (more than 4 points means risk of sarcopenia). | Every 3 months up to 18 months. | 
| Risk of falls | To the user. Assessed by the Downton Scale. The scoring range is 0 - 14 (more than 3 points means risk of falls). | Every 3 months up to 18 months. | 
| Cognitive status | To the user. Assessed by the Reisberg Global Deterioration Scale. The scoring range is 1 (no dementia)- 7 (late-stage dementia). | Every 3 months up to 18 months. | 
| Social network | To the user. Assessed by the Lubben Social Network Scale. The scoring range is 0 (less social engagement)- 30 (more social engagement). | Every 3 months up to 18 months. | 
| Chronic patient experience | To the user. Assessed by the Chronic Patient Experince Evaluation Instrument (IEXPAC). The scoring range is 0 (worst experience)- 110 (best experience). | Every 3 months up to 18 months. | 
| Quality of life related with health | To the user. Assessed by the EUROQOL-5D-3L. The scoring range is 0 (worst quality of life)- 100 (best quality of life). | Every 1 month up to 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older people, Home care, Functional capacity, Dependence