Live Better at Home in Catalonia

NCT05567965 | Unknown

• 1 other identifier: VMCCat1.0
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Geriatrics; Home Care Services

Keywords

Older people; Home care; Functional capacity; Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Functional capacity

  Every 3 months up to 18 months.

• Frailty

  Every 3 months up to 18 months.

• Risk of sarcopenia

  Every 3 months up to 18 months.

• Risk of falls

  Every 3 months up to 18 months.

• Cognitive status

  Every 3 months up to 18 months.

Other Outcomes (3)

• Physical activity grade

  Every 3 months up to 18 months.

• Caregiver overburden

  Every 3 months up to 18 months.

• Experience of the informal caregiver with people with chronic disease

  Every 3 months up to 18 months.

Study Arms (2)

Intensified home care intervention + Training

EXPERIMENTAL

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

Conventional home care intervention

ACTIVE COMPARATOR

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

Interventions

Home care intervention 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; Intensified home care intervention + Training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Spanish Society of Geriatrics and Gerontology: collaborator

Related Publications (1)

• 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.

  PMID: 37453249 DERIVED

Study Officials

• Jose Augusto Garcia Navarro

  Spanish Society of Geriatrics and Gerontology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduard Minobes

CONTACT

+34659350407; eduard.minobes@segg.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 5, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Access criteria will be made on demand