GeriatricsNCT05605392
Live Better at Home, Navarra ( VMNav )
A study testing Deinstitutionalization process in people with Geriatrics and Institutionalization, run by University of Vic - Central University of Catalonia at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Geriatrics, Institutionalization
- What is being tested?
- Deinstitutionalization process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Oct 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Residencia Santo Domingo
Estella-Lizarra, Navarre, 31200
Gemma Urralburu
- Recruiting
Residencia El Vergel
Pamplona, Navarre, 31014
Montse Equiza
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Geriatrics, Institutionalization
- Being tested
- Deinstitutionalization process
- Keywords
- Older people, Deinstitutionalization, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deinstitutionalization processOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Deinstitutionalization | Experimental | Not described Receives: Other: Deinstitutionalization process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every three months after signing the personalized support plan (baseline) up to 15 months
Secondary outcomes (7)
Functional capacity.
Assessed by the Barthel Index. The scoring rate is from 0 (total dependency)- 100 (slight dependency)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Every 3 months up to 15 months
Loneliness
Assessed by ESTE Scale. The scoring range is from 0 (low degree)- 30 (high degree)
Measured: Every 3 months up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start5 Oct 2022
- Primary completion28 Mar 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Geriatrics and Gerontology
- Responsible party
- Sponsor
- Investigators
- Jose Augusto García Navarro, Principal investigator, Spanish Society of Geriatrics and Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605392
- Sponsor's protocol ID
- VMCNav1.0
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data will result in some publications
Publications
Roncal-Belzunce V, Atares L, Escalada G, Minobes-Molina E, Pamies-Tejedor S, Carcavilla-Gonzalez N, Garcia-Navarro JA. First steps towards the deinstitutionalization of older adults: A protocol for the implementation of a complex intervention. Rev Esp Geriatr Gerontol. 2024 Mar-Apr;59(2):101453. doi: 10.1016/j.regg.2023.101453. Epub 2023 Dec 15.
PubMed 38103438
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Better at Home (Navarra): an Interventional Study
- ClinicalTrials.gov ID
- NCT05605392
- Acronym / sponsor ID
- VMCNav1.0
- Conditions
- Geriatrics, Institutionalization
- Keywords
- Older people, Deinstitutionalization, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Spanish Society of Geriatrics and Gerontology
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 28 Mar 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deinstitutionalization | Experimental | Other: Deinstitutionalization process |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- To have a place within the recruitment period for an indefinite period of time in one of the participating centers.
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deinstitutionalization processPhase 1: Comprehensive geriatric assessment to evaluate who might be a candidate for deinstitutionalization. Phase 2: Intervention: 1. 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. 2. 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. 3. 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. | Other | Deinstitutionalization |
Primary outcome
Change in quality of life.
Time frame: Every three months after signing the personalized support plan (baseline) up to 15 months
Assessed by Fumat Scale. Standard score (M= 10; Standard deviation (SD)= 3) of each quality of life dimension, percentiles, and quality of life Index
7 secondary outcomes
Functional capacity.
Time frame: Every 3 months up to 15 months
Frailty.
Time frame: Every 3 months up to 15 months
Cognitive status.
Time frame: Every 3 months up to 15 months
Change on performance activities of daily living.
Time frame: Every 3 months up to 15 months
Physical Activity
Time frame: Every 3 months up to 15 months
Depression
Time frame: Every 3 months up to 15 months
Loneliness
Time frame: Every 3 months up to 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 38103438Roncal-Belzunce V, Atares L, Escalada G, Minobes-Molina E, Pamies-Tejedor S, Carcavilla-Gonzalez N, Garcia-Navarro JA. First steps towards the deinstitutionalization of older adults: A protocol for the implementation of a complex intervention. Rev Esp Geriatr Gerontol. 2024 Mar-Apr;59(2):101453. doi: 10.1016/j.regg.2023.101453. Epub 2023 Dec 15.
- Individual participant dataSharing planned: Yes. All collected data will result in some publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Augusto García Navarro principal investigator
Spanish Society of Geriatrics and Gerontology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deinstitutionalization process in people with Geriatrics and Institutionalization, run by University of Vic - Central University of Catalonia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Roncal-Belzunce (+34613058353, victoriaroncal@ceoma.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life. (time frame: Every three months after signing the personalized support plan (baseline) up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.