Live Better at Home in Catalonia

Geriatrics Clinical Trial

— VMCat  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05567965
• Other study ID #: VMCCat1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2022
• Source: University of Vic - Central University of Catalonia
• Contact: Eduard Minobes
• Phone: +34659350407
• Email: eduard.minobes[@]segg.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Geriatrics

Intervention

Other:
• Home 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia	Spanish Society of Geriatrics and Gerontology

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity grade	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.	Every 3 months up to 18 months.
Other	Caregiver overburden	To the informal caregiver. Assessed by the Zarit Burden Scale. The scoring range is 5 (no overburden)- 35 (more overburden).	Every 3 months up to 18 months.
Other	Experience of the informal caregiver with people with chronic disease	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).	Every 3 months up to 18 months.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.