Live Better at Home in Catalonia

NCT ID: NCT05567965

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-06-30

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).

Conditions

Geriatrics; Home Care Services

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intensified home care intervention + Training

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.

Group Type: EXPERIMENTAL

Home care intervention

Intervention Type: OTHER

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.

Conventional home care intervention

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.

Group Type: ACTIVE_COMPARATOR

Home care intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Geriatrics and Gerontology

UNKNOWN

Sponsor Role: collaborator

University of Vic - Central University of Catalonia

OTHER

Sponsor Role: lead

Responsible Party

Eduard Minobes

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Augusto Garcia Navarro

Role: PRINCIPAL_INVESTIGATOR

Spanish Society of Geriatrics and Gerontology

Central Contacts

Eduard Minobes

Role: CONTACT

eduard.minobes@segg.es

+34659350407

References

Minobes-Molina E, Pamies-Tejedor S, Roncal-Belzunce V, Escalada San Adrian G, Atares Rodriguez L, Garcia-Navarro JA. Multimodal home care intervention for dependent older people "Live better at home": Protocol of a randomized clinical trial. Rev Esp Geriatr Gerontol. 2023 Jul-Aug;58(4):101383. doi: 10.1016/j.regg.2023.101383. Epub 2023 Jul 13.

Reference Type: DERIVED

PMID: 37453249 (View on PubMed)

Other Identifiers

VMCCat1.0

Identifier Type: -

Identifier Source: org_study_id