An interventional study of non-pharmacological multicomponent in Social Isolation, Loneliness (Descriptors Included in the MeSH), sponsored by Andaluz Health Service. Status unknown at 1 site in Spain. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Andaluz Health Service · Not applicable, Interventional, and Supportive care
Among 15 studies in Social Isolation with a site in Spain — 4 open to participants now, 6 under way, none of them phase 3. Social Isolation · Spain.
Among the 15 studies in Social Isolation with a site in Spain, this one is the 4th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2018, is one of 10 with no phase, and was the 1st registered.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's planned enrollment of 114 is above the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →4 of the 15 studies in Social Isolation with a site in Spain are open now.
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 34 Social Isolation studies recruiting now, 22 (65%) set no upper age limit and 6 (18%) stop at 75 or younger; 4 take children under 18; 18 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2018.
Median enrollment 82 across the 12 interventional studies, 200 across the 3 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
None of the 15 has an industry lead sponsor. The 10 most frequent:
Andaluz Health Service is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Andaluz Health Service has 1 study filed under Social Isolation — fewer than ten, so there is no comparison to draw.
3 of the studies in Social Isolation with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06956794Consorci Sanitari de TerrassaMultimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone | 2026-12-01 |
| NCT06606431Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaACOMPANYEM: A COMmunity Program Accessing Lonely, Disabled Neighbors (Young, Elder, and Midlife) | 2026-12-31 |
| NCT06701916Clinica Universidad de Navarra, Universidad de NavarraSHARE Study: Social Chronic Heart Failure Person-centred cARE Intervention | 2027-06-30 |
Among the 15 studies in Social Isolation with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Persons with cognitive impairment or dementia, difficulty in responding to scales, legal incapacitation or not giving consent will be excluded.
9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114).
Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL.
The intervention includes 8 sessions at home [1 hour], every 15 days and 4 telephone [30 minutes] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL.
Univariate, bivariate and multivariate statistical analysis (multiple linear regression).
-Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District.
-Subjects and methods: Subjects with social isolation. Age 65 or older. Residents in your home. Telecare users. Persons with cognitive impairment or dementia, difficulty in responding to scales, legal incapacitation or not giving consent will be excluded.
9 health centers will be randomly assigned to the intervention and control groups. The people of both groups will be evaluated at baseline, at 4 and at 6 months. 57 subjects will be included in each group (n = 114).
Variables: a) Independent: of the professional and of the patients (sociodemographic, healthcare, morbidity, intervention performed -multicomponent vs. non-intervention-) b) Dependents: social support, loneliness and HRQoL.
The intervention includes 6 sessions at home [30-60 minutes], every 15 days and 5 telephone [20 minutes] -1 monthly-. To measure the effectiveness of the intervention, the Duke-UNC Functional Social Support Questionnaire (DUFSS), the De Jong-Gierveld Scale of loneliness, and the EuroQol-5D will be used to measure HRQoL. Analysis by intention to treat. Univariate, bivariate and multivariate statistical analysis (multiple linear regression).
-Aspects ethico-legal: Standards of good clinical practice and ethical principles of the Declaration of Helsinki. Informed consent. Application for authorization to the management of the Sanitary District. Approval of the Ethics and Clinical Research Committee.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non-pharmacological multicomponent intervention
Behavioral: non-pharmacological multicomponent
Not intervention, usual attention
Following the proposal of Nicholson \& Shellman, (2013) collected in its CARELINK program, an intervention is proposed that includes: 6 sessions at home \[30-60 minutes\] for 16 weeks (1 fortnightly session) and 5 telephone sessions \[20 min.\] That will be intercalated (in the 16 weeks) depending on the particular characteristics of each person. The first visit, aimed at defining objectives and creating a relationship of trust for future visits.
Social isolation
Duke-UNC Functional Social Support Questionnaire (DUFSS), which reflects the opinion on the availability of other people to offer help in difficulties, skills in social relations and empathic and emotional communication.
Time frame: 6 months
loneliness
De Jong-Gierveld de Soledad Scale, which assesses individual subjective perception of social participation or isolation in the elderly population.
Time frame: 6 months
Health Related Quality of Life
Health Related Quality of Life (EuroQol-5D scale)
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Apr 2020, 22 months.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 22 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Andaluz Health Service