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Live Better at Home in Catalonia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05567965
Acronym
VMCat
Enrollment
160
Registered
2022-10-05
Start date
2022-11-30
Completion date
2024-06-30
Last updated
2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatrics, Home Care Services

Keywords

Older people, Home care, Functional capacity, Dependence

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).

Interventions

OTHERHome care intervention

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.

Sponsors

Spanish Society of Geriatrics and Gerontology
CollaboratorUNKNOWN
University of Vic - Central University of Catalonia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in time from baseline until application for nursing home admissionEvery 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.To the user. Assessed by asking.

Secondary

MeasureTime frameDescription
Risk of fallsEvery 3 months up to 18 months.To the user. Assessed by the Downton Scale. The scoring range is 0 - 14 (more than 3 points means risk of falls).
Social networkEvery 3 months up to 18 months.To the user. Assessed by the Lubben Social Network Scale. The scoring range is 0 (less social engagement)- 30 (more social engagement).
Chronic patient experienceEvery 3 months up to 18 months.To the user. Assessed by the Chronic Patient Experince Evaluation Instrument (IEXPAC). The scoring range is 0 (worst experience)- 110 (best experience).
Quality of life related with healthEvery 1 month up to 18 months.To the user. Assessed by the EUROQOL-5D-3L. The scoring range is 0 (worst quality of life)- 100 (best quality of life).
Functional capacityEvery 3 months up to 18 months.To the user. Assessed by the Barthel Index. The scoring range is 0 (total dependency)-100 (slight dependency)
FrailtyEvery 3 months up to 18 months.To the user. Assessed by the Frail-VIG index. The scoring range is 0 (no frailty)- 25 (advanced frailty).
Risk of sarcopeniaEvery 3 months up to 18 months.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).
Cognitive statusEvery 3 months up to 18 months.To the user. Assessed by the Reisberg Global Deterioration Scale. The scoring range is 1 (no dementia)- 7 (late-stage dementia).

Other

MeasureTime frameDescription
Experience of the informal caregiver with people with chronic diseaseEvery 3 months up to 18 months.To the informal caregiver. Assessed by the Chronic Patient Experince Evaluation Instrument for caregivers(IEXPAC caregivers). The scoring range is 0 (worst experience)- 120 (best experience).
Caregiver overburdenEvery 3 months up to 18 months.To the informal caregiver. Assessed by the Zarit Burden Scale. The scoring range is 5 (no overburden)- 35 (more overburden).
Physical activity gradeEvery 3 months up to 18 months.To the informal caregiver. Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ). The classification ranges from low level of physical activity to high level of physical activity.

Contacts

Primary ContactEduard Minobes
eduard.minobes@segg.es+34659350407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026