ACOMPANYEM: A COMmunity Program Accessing Lonely, Disabled Neighbors (Young, Elder, and Midlife)

NCT ID: NCT06606431

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Social prescription prioritizes interventions for people at risk of social isolation or unwanted loneliness based on community assets and offers them a series of activities that can contribute to their emotional well-being as a healthy alternative to medicalized healthcare. Disabled homebound people deal with more difficulty accessing the social health assets available in the community. Volunteers from the same neighborhood may accomplish the social function of accompaniment and listening accessing them at home or walking them out to attain social prescription goals. The Community Emotional Well-Being Referent (REBEC) may enhance all of this by conducting emotional counseling and management groups for volunteers.

OBJECTIVE: To evaluate the effectiveness of a community intervention of accompaniment and emotional management with volunteers on the unwanted loneliness of people with social isolation, their emotional well-being, and their quality of life.

METHODOLOGY: a community-based quasi-experimental non-randomized pre-post intervention study with control group, and a qualitative study. Candidate detection by the Driving Group, composed of neighborhood organizations and the community health team, was conducted opportunistically. Recruitment of isolated individuals and volunteers was carried out, with registration based on inclusion criteria. Implementation of the multi-level intervention for volunteers and isolated individuals took place at home or by participating in community resources on the street, with parallel support groups for volunteers using REBEC. Each round of participants was followed for three months, continuing until the sample was complete. Qualitative analysis was conducted upon reaching information saturation. In cases where architectural barriers were detected, technical aids (such as portable stairlifts) were proposed, and their impact was studied.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Isolation or Loneliness Homebound Persons Disabled Persons

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment, Pre-Post Intervention
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participant Group

The intervention is multilevel and is based on bringing together two population groups in the community with complementary needs:

1. People over 16 years of age isolated at home due to mobility problems or chronic mental illness.
2. Volunteers from the neighborhood, especially people with interested in improving their emotional well-being.

REBEC will conduct a first individual interview to confirm that the volunteers are emotionally and vitally stable at the time of the intervention.

A personalized relational dynamic of help will be set up in each case (one-to-one interaction, relational level). This interaction can consist of listening at home or going with the person on the street to bring them closer to the different proposals for community social activities.

The group of social isolation and/or unwanted loneliness will also receive support from the community team, to provide a personalized response to the physical, health, social or psychological needs detected by the v

Group Type EXPERIMENTAL

Multileveled-community approach

Intervention Type BEHAVIORAL

One-to-one delivered interaction at relational level (Interpersonal Relations, Volunteers) Socio-health interaction at personalized level (Social Work) Group delivered interaction for volunteers (Group Dynamics) Community-level interactions (Social Cohesion, Community Networks)

Control Group

In-waiting list for intervention in future rounds; habitual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multileveled-community approach

One-to-one delivered interaction at relational level (Interpersonal Relations, Volunteers) Socio-health interaction at personalized level (Social Work) Group delivered interaction for volunteers (Group Dynamics) Community-level interactions (Social Cohesion, Community Networks)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Previously detected by community and professional assets among people over 16 years of age with the following criteria:

* Disabled physical or mental homebound persons.
* Unwanted loneliness, with difficulty in accessing other assets of the social prescription program.
* less than 8 on the Oslo Social Support Scale or less than 20 on the LSNS-R scale or less than 2 on the LSNR-6 scale in people over 65 years of age.

Exclusion Criteria

* Impossibility of communication
* End-of-life situations.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Catala de Salut

OTHER_GOV

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sara Martínez Torres

Research Technician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Atenció Primària Bonavista-La Canonja. Gerència Territorial Camp de Tarragona, Institut Català de la Salut, Barcelona, Spain

Tarragona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paloma Camós-Guijosa, Doctor

Role: CONTACT

977 778 518 ext. +34

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24/095-P (Ethics Committee nº)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.