NCT05605392

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 24, 2022

Last Update Submit

October 28, 2022

Conditions

GeriatricsInstitutionalization

Keywords

Older peopleDeinstitutionalizationQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Functional capacity.

    Every 3 months up to 15 months

  • Frailty.

    Every 3 months up to 15 months

  • Cognitive status.

    Every 3 months up to 15 months

  • Change on performance activities of daily living.

    Every 3 months up to 15 months

  • Physical Activity

    Every 3 months up to 15 months

  • +2 more secondary outcomes

Study Arms (1)

Deinstitutionalization

EXPERIMENTAL
Other: Deinstitutionalization process

Interventions

Deinstitutionalization processOTHER

Phase 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.

Deinstitutionalization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Residencia Santo Domingo

Estella-Lizarra, Navarre, 31200, Spain

RECRUITING

Residencia El Vergel

Pamplona, Navarre, 31014, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38103438DERIVED

Study Officials

  • Jose Augusto García Navarro

    Spanish Society of Geriatrics and Gerontology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Roncal-Belzunce

CONTACT

+34613058353victoriaroncal@ceoma.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 4, 2022

Study Start

October 5, 2022

Primary Completion

March 28, 2023

Study Completion

June 30, 2024

Last Updated

November 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

All collected data will result in some publications

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting 6 months after publication
Access Criteria
Access criteria will be made on demand

Locations

ES(2)