Social Isolation or LonelinessACOMPANYEMNCT06606431
ACOMPANYEM: A COMmunity Program Accessing Lonely, Disabled Neighbors (Young, Elder, and Midlife)
A study testing Multileveled-community approach in people with Social Isolation or Loneliness and Homebound Persons, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Social Isolation or Loneliness, Homebound Persons, Disabled Persons
- What is being tested?
- Multileveled-community approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Impossibility of communication
- End-of-life situations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Centre Atenció Primària Bonavista-La Canonja. Gerència Territorial Camp de Tarragona, Institut Català de la Salut, Barcelona, Spain
Tarragona
About this study
Official title: Accompaniment of Isolated People by Volunteers From the Neighborhood: a Community Mixed Quasi-experimental/Qualitative Clinical Trial
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.
- Being tested
- Multileveled-community approach
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multileveled-community approachBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | 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 Receives: Behavioral: Multileveled-community approach |
| Control Group | No intervention | In-waiting list for intervention in future rounds; habitual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Support/Isolation
Social Support Scale (OSLO 3) (Kocalevent, 2018).
The Oslo 3 social support scale is part of the ECHI list (European Community Health Indicators). Study the relationship between support and psychological suffering. It consists of three questions:
- How many people do you have around when you need them because you have a severe problem? Outcomes: 0, 1-2, 3-5, 5+.
- What interest do people show in what you do? Answers: many, some, uncertain, little, not at all.
- Is it easy for you to ask your neighbors for help if you need it? Answers: quite easy, easy, possible, difficult, exceedingly difficult.
The result of the scale is the sum of the score of all the questions. The range is between 3 and 14 points. Outcome classifies as follows:
- Between 3 and 8: poor social support.
- Between 9 and 11: medium social support.
- Between 12 and 14 high social support.
Measured: 3 months for each round
Emotional Well-Being
Emotional Well-being Scale (7 items) SWEMWBS (Castellví, 2017). The questionnaire consists of seven items measured with a Likert-type scale, with five answer options (1 never - 5 always), about how the person has felt in the last two weeks. This questionnaire has recently been adapted to Catalan and Spanish and added to the Catalan Health Survey.
The result of the emotional well-being test is the sum of the score of each item. Therefore, the score ranges from 5 to 35.
There are no cut-off points. Well-being is a continuum, and we cannot consider itself high, medium, or low. The interesting thing is to see the evolution of well-being in the same person.
Measured: 3 months for each round
Loneliness
Unwanted loneliness will be addressed separately in a qualitative study as a complex and empirical phenomenon, not guided from the outset by predetermined theories (constructivist perspective). It will be measured in a semi-structured interview with a single binary answer question: "Do you feel lonely?" (yes/no). This will be followed by a Visual Analogue Scale to attempt to measure the subjective feeling of loneliness, which could be more associated with poor psychological health than with the perception of a reduction in the number of relationships. Additionally, a single question will be used to evaluate whether the person wishes to be accompanied (yes/no), followed by another VAS to measure the extent of this desire.
Measured: 3 months
Health-Related Quality of Life (HRQoL)
The EQ-5D is a HRQoL instrument used both in general population and in groups of patients with diverse conditions. The individual himself assesses his or her state of health, first with descriptive system that values severity of symptoms and then in visual analogue scale (VAS). Ther are five dimensions of health (mobility, personal care, daily activities, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, problems or moderate problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to their state of health in each of the dimensions, referring to the same day that they complete the questionnaire. In each dimension of the EQ-5D, the severity levels are encoded with a 1 if the answer option is (no (have) problems); with a 2 if the answer option is (some or moderate problems); and with a 3 if the answer option is (many problems).
Measured: 3 months for each round
Social Support/Isolation for aged more than 65
The Lubben Social Network Scale (LSNS) assesses perceived social support and risk of isolation in older adults. Developed by J. Lubben and team, it evaluates the size, proximity, and frequency of social contacts through a brief series of questions, typically taking 10-15 minutes. The LSNS-R has 12 items, split between family and non-family contacts, and provides four results: three subscales for perceived social support (family, non-family, global; ranges 0-30, 0-60) and one for risk of isolation. Scores reveal risk levels: low (more than 30), moderate (26-30), high (21-25), and social isolation (less than 20). The LSNS-6, a shorter version with six items, covers family and non-family relations and yields two results: perceived social support (range 0-30) and risk of isolation (score ≤12) (Lubben et al., 2006; Pérez Pavilla, 2021)
Measured: 3 months for each round
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Social Isolation or LonelinessStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, Pre-Post Intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Responsible party
- Principal investigator, Sara Martínez Torres, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606431
- Sponsor's protocol ID
- 24/095-P (Ethics Committee nº)
- Acronym
- ACOMPANYEM
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camos-Guijosa P, Caro-Duran A, Belles-Mur E, Domingo-Arasa B, Vasco-Rodriguez Y. Accompaniment of isolated people by volunteers from the neighborhood (ACOMPANYEM). A community trial with a nested qualitative study. Gac Sanit. 2025;39:102442. doi: 10.1016/j.gaceta.2024.102442. Epub 2025 Jan 17.
PubMed 39818040
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accompaniment of Isolated People by Volunteers From the Neighborhood: a Community Mixed Quasi-experimental/Qualitative Clinical Trial
- ClinicalTrials.gov ID
- NCT06606431
- Acronym / sponsor ID
- ACOMPANYEM / 24/095-P (Ethics Committee nº)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment, Pre-Post Intervention
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Behavioral: Multileveled-community approachThe 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 |
| Control Group | No intervention | –In-waiting list for intervention in future rounds; habitual care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Impossibility of communication
- End-of-life situations.
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 |
|---|---|---|
| Multileveled-community approachOne-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) | Behavioural | Participant Group |
Primary outcome
Social Support/Isolation
Time frame: 3 months for each round
Social Support Scale (OSLO 3) (Kocalevent, 2018). The Oslo 3 social support scale is part of the ECHI list (European Community Health Indicators). Study the relationship between support and psychological suffering. It consists of three questions: * How many people do you have around when you need them because you have a severe problem? Outcomes: 0, 1-2, 3-5, 5+. * What interest do people show in what you do? Answers: many, some, uncertain, little, not at all. * Is it easy for you to ask your neighbors for help if you need it? Answers: quite easy, easy, possible, difficult, exceedingly difficult. The result of the scale is the sum of the score of all the questions. The range is between 3 and 14 points. Outcome classifies as follows: * Between 3 and 8: poor social support. * Between 9 and 11: medium social support. * Between 12 and 14 high social support.
Emotional Well-Being
Time frame: 3 months for each round
Emotional Well-being Scale (7 items) SWEMWBS (Castellví, 2017). The questionnaire consists of seven items measured with a Likert-type scale, with five answer options (1 never - 5 always), about how the person has felt in the last two weeks. This questionnaire has recently been adapted to Catalan and Spanish and added to the Catalan Health Survey. The result of the emotional well-being test is the sum of the score of each item. Therefore, the score ranges from 5 to 35. There are no cut-off points. Well-being is a continuum, and we cannot consider itself high, medium, or low. The interesting thing is to see the evolution of well-being in the same person.
Loneliness
Time frame: 3 months
Unwanted loneliness will be addressed separately in a qualitative study as a complex and empirical phenomenon, not guided from the outset by predetermined theories (constructivist perspective). It will be measured in a semi-structured interview with a single binary answer question: "Do you feel lonely?" (yes/no). This will be followed by a Visual Analogue Scale to attempt to measure the subjective feeling of loneliness, which could be more associated with poor psychological health than with the perception of a reduction in the number of relationships. Additionally, a single question will be used to evaluate whether the person wishes to be accompanied (yes/no), followed by another VAS to measure the extent of this desire.
Health-Related Quality of Life (HRQoL)
Time frame: 3 months for each round
The EQ-5D is a HRQoL instrument used both in general population and in groups of patients with diverse conditions. The individual himself assesses his or her state of health, first with descriptive system that values severity of symptoms and then in visual analogue scale (VAS). Ther are five dimensions of health (mobility, personal care, daily activities, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, problems or moderate problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to their state of health in each of the dimensions, referring to the same day that they complete the questionnaire. In each dimension of the EQ-5D, the severity levels are encoded with a 1 if the answer option is (no (have) problems); with a 2 if the answer option is (some or moderate problems); and with a 3 if the answer option is (many problems).
Social Support/Isolation for aged more than 65
Time frame: 3 months for each round
The Lubben Social Network Scale (LSNS) assesses perceived social support and risk of isolation in older adults. Developed by J. Lubben and team, it evaluates the size, proximity, and frequency of social contacts through a brief series of questions, typically taking 10-15 minutes. The LSNS-R has 12 items, split between family and non-family contacts, and provides four results: three subscales for perceived social support (family, non-family, global; ranges 0-30, 0-60) and one for risk of isolation. Scores reveal risk levels: low (more than 30), moderate (26-30), high (21-25), and social isolation (less than 20). The LSNS-6, a shorter version with six items, covers family and non-family relations and yields two results: perceived social support (range 0-30) and risk of isolation (score ≤12) (Lubben et al., 2006; Pérez Pavilla, 2021)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 39818040Camos-Guijosa P, Caro-Duran A, Belles-Mur E, Domingo-Arasa B, Vasco-Rodriguez Y. Accompaniment of isolated people by volunteers from the neighborhood (ACOMPANYEM). A community trial with a nested qualitative study. Gac Sanit. 2025;39:102442. doi: 10.1016/j.gaceta.2024.102442. Epub 2025 Jan 17.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multileveled-community approach in people with Social Isolation or Loneliness and Homebound Persons, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site 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 4 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: opening soon, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paloma Camós-Guijosa, Doctor (977 778 518 ext. +34, pcamos.tgn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Support/Isolation (time frame: 3 months for each round). The study lists 5 primary outcomes in all. 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 NCT06606431, 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 23 Sep 2024.