Clinical trial NCT05605392: Live Better at Home, Navarra ( VMNav )
Official title: Live Better at Home (Navarra): an Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Geriatrics
Institutionalization
Keywords: Older people
Deinstitutionalization
Quality of life
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Spanish Society of Geriatrics and Gerontology
First posted: 2022-11-04
Enrollment: 241
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Alternatives to institutionalization with adapted housing and community supports may allow institutionalized people who so desire to be deinstitutionalized and continue their life in the community. This transition can fulfill the wishes of these people and may improve the quality of their life and functionality.

Detailed description: Many older adults want to stay and be cared for at home, living in the community. However, long-term care facilities are increasingly becoming places where people live until death. Admissions are often conditioned by the characteristics of the support network rather than by the individual's clinical condition or dependency level. In addition, persistent problems around the cost and quality of housing with a lack of sufficient adapted housing and sheltered housing and inequalities in the distribution of social resources often limit the consolidation of personalized care and support planning.

Under this pretext, and if many people want to live at home for the rest of their lives, our research group aims to offer the possibility to nursing home residents from two nursing homes in Navarra of returning to the community by means of case management methodology and accommodation support. This completely innovative study aims to provide data to help the design and implementation of future studies addressed in this field.

The study consists of two stages:

1. A cross-sectional observational stage for the assessment. Objectives: Quantify the proportion of people who could return safely and quantify the proportion of people who would like to live in the community.
2. An analysis of factors related to the deinstitutionalization process and an intervention stage. Objective: assess the feasibility of this tailored intervention through case management methodology and study the impact of a deinstitutionalization process on participants for whom the transition is achieved.

In addition, this study will be accompanied by a sub-study with a pseudo-qualitative approach. The main objective of this part is to characterize the discourses associated with the willingness to return to the community and the deinstitutionalization process and to identify which evaluative elements concur (barriers and facilitators) and are prioritized in decision-making about a possible deinstitutionalization process. Qualitative research is needed for complex interventions to explore the obstacles and facilitators and to understand the intervention's components.

Eligibility criteria: Inclusion Criteria:

Phase 1:

* To have a place within the recruitment period for an indefinite period of time in one of the participating centers.

Phase 2:

* To express willingness to be deinstitutionalized and return to community.
* To obtain a favorable report in phase 1 from the project team on the feasibility and safety of returning to community.

Exclusion Criteria:

* Refusal to sign the informed consent form by the resident or, failing that, by the legal representative.
* The existence of a judicial authorization for involuntary admission of the resident to the residential facility.

Primary outcomes:
measure: Change in quality of life.
timeFrame: Every three months after signing the personalized support plan (baseline) up to 15 months
Secondary outcomes:
measure: Functional capacity.
timeFrame: Every 3 months up to 15 months
measure: Frailty.
timeFrame: Every 3 months up to 15 months
measure: Cognitive status.
timeFrame: Every 3 months up to 15 months
measure: Change on performance activities of daily living.
timeFrame: Every 3 months up to 15 months
measure: Physical Activity
timeFrame: Every 3 months up to 15 months
measure: Depression
timeFrame: Every 3 months up to 15 months
measure: Loneliness
timeFrame: Every 3 months up to 15 months
Other outcomes:
Locations:
city: Estella
country: Spain
facility: Residencia Santo Domingo
state: Navarra
city: Pamplona
country: Spain
facility: Residencia El Vergel
state: Navarra
Study officials:
affiliation: Spanish Society of Geriatrics and Gerontology
name: Jose Augusto García Navarro
role: PRINCIPAL_INVESTIGATOR
References: