Live Better at Home, Navarra ( VMNav )

Geriatrics Clinical Trial

Official title:

Live Better at Home (Navarra): an Interventional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605392
• Other study ID #: VMCNav1.0
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: University of Vic - Central University of Catalonia
• Contact: Victoria Roncal-Belzunce
• Phone: +34613058353
• Email: victoriaroncal[@]ceoma.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 241
• Est. completion date: June 30, 2024
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Geriatrics
• Institutionalization

Intervention

Other:
• Deinstitutionalization process
Phase 1: Comprehensive geriatric assessment to evaluate who might be a candidate for deinstitutionalization. Phase 2: Intervention: Support plan: design a plan agreed upon with the participant to provide resources to the person's needs and which guarantees support during the transition and beyond. Transition process: progressive withdrawal of support in the institution and implementation of support and adaptation in the community, with different types of accommodation depending on the needs and preferences of each participant. Coordination with primary care teams, social services, and other community resources. Case follow-up and gradual withdrawal of the project team. If the process does not go as the person expects, or difficulties are encountered that cannot be resolved, the participant will have the option and choice, if desired, to return to the residence at any time during the process.

Locations

Country	Name	City	State
Spain	Residencia Santo Domingo	Estella	Navarra
Spain	Residencia El Vergel	Pamplona	Navarra

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life.	Assessed by Fumat Scale. Standard score (M= 10; Standard deviation (SD)= 3) of each quality of life dimension, percentiles, and quality of life Index	Every three months after signing the personalized support plan (baseline) up to 15 months
Secondary	Functional capacity.	Assessed by the Barthel Index. The scoring rate is from 0 (total dependency)- 100 (slight dependency)	Every 3 months up to 15 months
Secondary	Frailty.	Assessed by the Frail-VIG Index. The scoring range is from 0 (no frailty)- 25 (advanced frailty)	Every 3 months up to 15 months
Secondary	Cognitive status.	Assessed by the mini-mental test. The scoring range is from 0 (severe cognitive impairment) to 30 (no cognitive impairment)	Every 3 months up to 15 months
Secondary	Change on performance activities of daily living.	Assessed by BELS (Basic Everyday Living Skills). It consists of two scales: one to evaluate the opportunity to performance (from 0- no opportunity to 2- total opportunity) and the other for the real performance of activities (from 0- no performance of any activity- to 4- normal level of performance).	Every 3 months up to 15 months
Secondary	Physical Activity	Assessed by IPAQ questionnaire. The classification ranges from a low level of physical activity to high level of physical activity.	Every 3 months up to 15 months
Secondary	Depression	Assessed by Yesavage Geriatric Depression Scale. The scoring range is from 0 (no depression) - 10 (high depression)	Every 3 months up to 15 months
Secondary	Loneliness	Assessed by ESTE Scale. The scoring range is from 0 (low degree)- 30 (high degree)	Every 3 months up to 15 months