Live Better at Home, Navarra ( VMNav )

Live Better at Home (Navarra): an Interventional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Geriatrics; Institutionalization
• Intervention / Treatment: Other: Deinstitutionalization process

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.

• Study Type: Interventional
• Enrollment (Anticipated): 241
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Roncal-Belzunce; Phone Number: +34613058353; Email: victoriaroncal@ceoma.org

Study Locations

• Spain
  • Navarra
    • Estella, Navarra, Spain, 31200
      • Recruiting
      • Residencia Santo Domingo
      • Contact: Gemma Urralburu
    • Pamplona, Navarra, Spain, 31014
      • Recruiting
      • Residencia El Vergel
      • Contact: Montse Equiza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Deinstitutionalization

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Loneliness	Assessed by ESTE Scale. The scoring range is from 0 (low degree)- 30 (high degree)	Every 3 months up to 15 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 (Actual): October 5, 2022
• Primary Completion (Anticipated): March 28, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Older people; Deinstitutionalization
• Other Study ID Numbers: VMCNav1.0

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