Live Better at Home in Catalonia (VMCat)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Geriatrics; Home Care Services
• Intervention / Treatment: Other: Home care intervention

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).

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduard Minobes; Phone Number: +34659350407; Email: eduard.minobes@segg.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia
• Collaborators: Spanish Society of Geriatrics and Gerontology
• Investigators: Principal Investigator: Jose Augusto García Navarro, Spanish Society of Geriatrics and Gerontology

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Dependence; Older people; Functional capacity; Home care
• Other Study ID Numbers: VMCCat1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data will result in some publications
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Access criteria will be made on demand
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No