LonelinessSoledadLPNCT06829758
Compartiendo Salud: Community-Based Intervention for Loneliness
A study testing Compartiendo Salud in people with Loneliness, run by Servicio Canario de Salud at 1 site in Spain.
Trial summary
Unwanted loneliness is the gap between the social relations a person has and those they want. The main objective of this research is to assess the impact of a multidimensional community-based intervention on the feeling of unwanted loneliness in the population over the age of 65 years old, who living alone, under… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Loneliness
- What is being tested?
- Compartiendo Salud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People over the age of 65 and living alone
- Nursing diagnosis of social risk
- Nursing diagnosis of social isolation
Who cannot join
- presenting moderate/severe cognitive decline or Pfeiffer scores above 6
- individuals with uncorrected hearing deficits that hinder group interaction
- participants not subjected to the pre- and post-interventions measurements
- participants that do not take part in at least four of the five sessions scheduled
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, 1 recruiting
- Recruiting
La Palma Health Area. Canary Islands Health Service.
Santa Cruz de La Palma
Martín Rodríguez-Álvaro, PhD, mrodrigu@ull.edu.es
About this study
Official title: Effectiveness of a Community Intervention in Reducing the Feeling of Unwanted Loneliness, Social Risk, and Social Isolation in the Population Over 65 Years Old in La Palma, Focusing on Healthy Habits, Sleep Hygiene, and Digital Literacy
Unwanted loneliness is the gap between the social relations a person has and those they want. The main objective of this research is to assess the impact of a multidimensional community-based intervention on the feeling of unwanted loneliness in the population over the age of 65 years old, who living alone, under social risk or socially isolated living in the La Palma island.
Read the detailed description
Loneliness is strongly associated with a significant impact on physical health, depression and may in fact be an independent risk factor for depression. Fur-thermore, it is negatively associated with healt problems, like higher blood pressure, poorer sleep, immune responses to stress, and poorer cognition over time in the elderly. The absence of personal connections is related to the adoption of worse life habits and to increased morbidity, with the consequent higher risk of suf-fering cardiovascular and endocrine diseases, mental health pathologies and risk of falls.
The secondary objectives proposed are as follows: Increasing the number of opportunities for social interaction during the intervention; Contributing tools to improve the participants' social skills in the intervention; Fostering self-care and healthy habits in the participants; Reducing maladaptive thoughts; Educating on sleep hygiene measures and non-pharmacological treatments.
The null hypothesis (H0) of this research is that in the population under study, the proposed multidimensional community intervention will not significantly impact the feeling of unwanted loneliness and the health management of these subjects.
- Conditions
- Loneliness
- Being tested
- Compartiendo Salud
- Keywords
- Social Support, Community Health Nursing, Health Education, Aged
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compartiendo SaludBehavioural
The intervention proposed (Compartiendo Salud) is a multicomponent intervention based on prevention and on promoting the health of older adults that live alone. The community-based intervention consists in five workshops that are carried out during a week (one day for each workshop). The sessions (which last 2.5 hours each) are designed in an expository and participatory way, using gaming dynamics that foster learning and social interaction. The content of the workshops is the same for all BHDs. Each workshop addresses risk factors that predispose the population to experiencing more unwanted loneliness and social isolation. The concepts corresponding to each of the five sessions that comprise the intervention are: Sleep hygiene, Healthy and sustainable eating habits, Physical activity and exercise, Memory and music therapy, Digital literacy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention proposed (Compartiendo Salud) is a multicomponent intervention based on prevention and on promoting the health of older adults that live alone. Quasi-experimental study was designed with pre- and post- intervention (at three months) measurements, with no Control Group or randomisation. Receives: Behavioral: Compartiendo Salud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Feeling of unwanted loneliness
It was measured using the "UCLA (University of California at Los Angeles) Loneliness scale" test validated in Spain. This instrument is based on three dimensions: Relational connection; Social connection; and Self-perceived isolation. It uses a 4-point scale ranging from "Never" to "Frequently" for responses 10 items. Scores above 30 correspond to "No loneliness", between 20 and 30 mean "Moderate loneliness" and less than 20 points is "Severe loneliness"
Measured: Pre- and post- intervention (at three months)
Secondary outcomes (13)
Number of Participants with Social risk
It was measured using the Gijón Social risk detection questionnaire. It assesses family and economic situations, housing, social relations and support from social networks. It uses a 5-point scale ranging from best to worse situation, for responses 5 items. Scores: Good/Acceptable social situation: from 5 to 9 points; Social risk: from 10 to 14; and social problem: more than 15
Measured: Pre- and post- intervention (at three months)
Number of Participants with Low Perceived social support
It was measured with Duke's questionnaire. It assesses perceived social support and consists of 11 items, each one assessed with a Likert scale from 1 to 5. Scores equal to or higher than 32 indicate "Normal support", whereas less than 32 points means "Low perceived social support"
Measured: Pre- and post- intervention (at three months)
Number of Participants with Anxiety or depression
They were assessed using Goldberg's questionnaire with two subscales: Anxiety and Depression. Each of them is structured with 4 initial screening items to determine the probability of a mental disorder and a second group with 5 items that are only formulated if positive answers are given to the screening questions (at least 2 in the Anxiety subscale and at least 1 in the Depression subscale). The type of response of the questionnaire is dichotomous (Yes/No). The cut-off points are as follows: scores equal to or higher than 4 for the Anxiety subscale; and values equal to or higher than 2 for Depression. In the geriatric population, it has been proposed to use it as a single scale, with a cut-off point equal to or higher than 6
Measured: Pre- and post- intervention (at three months)
Number of Participants with Risk of loneliness
Nursing diagnosis "Risk of loneliness" (Yes/No) and presence/absence of each of its defining characteristics: Affective deprivation; Emotional Deprivation; Physical isolation; Social isolation.
Measured: Pre- and post- intervention (at three months)
Number of Participants with Social Isolation
Nursing diagnosis "Social Isolation" (Yes/No) and presence/absence of each of its defining characteristics: Low social activity levels; Change in physical aspect; Explicit dissatisfaction with social connections; Social reclusion; Social behaviour inconsistent with cultural norms; Reporting feeling insecure in public; Reduced eye contact.
Measured: Pre- and post- intervention (at three months)
Number of Participants with Smoking
The smoking assessment included in the habits module of the electronic clinical history of Primary Health Care of the Canary Islands Health Service Drago-AP will be used: Non-smoker/Smoker in undetermined phase/Smoker in pre-contemplation phase (consonant)/Smoker in contemplation phase (dissonant)/Smoker in preparation phase/Smoker in action phase/Smoker in maintenance phase/Former smoker since 1-10 years/Former smoker since more than 10 years/Passive smoker
Measured: Pre- and post- intervention (at three months)
Number of Participants with alcoholism
The alcoholism assessment included in the habits module of the electronic clinical history of Primary Health Care of the Canary Islands Health Service Drago-AP will be used: Non-drinker/Moderate drinker/Risk drinker/Drinking problem
Measured: Pre- and post- intervention (at three months)
Number of Participants without sleep problems
Sleep problem (Yes/No)
Measured: Pre- and post- intervention (at three months)
Number of Participants with caregiver
Dichotomous variables (Yes/No)
Measured: Pre- and post- intervention (at three months)
Number of Participants belonging to an organized group
Dichotomous variables (Yes/No)
Measured: Pre- and post- intervention (at three months)
Number of Participants what does it feel like Integrated in the area where they live
Dichotomous variables (Yes/No)
Measured: Pre- and post- intervention (at three months)
Number of Participants with Activities in free and/or leisure time
Dichotomous variables (Yes/No)
Measured: Pre- and post- intervention (at three months)
Number of Participants with Home-based care; Social assistance
Dichotomous variables (Yes/No)
Measured: Pre- and post- intervention (at three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Mar 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servicio Canario de Salud
- Sponsor type
- University, hospital or other
- Collaborators
- University of La Laguna
- Responsible party
- Sponsor
- Investigators
- Alba Francisco-Sánchez, Nursing Specialist, Principal investigator, Atención Primaria. Área de Salud de La Palma. Servicio Canario de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829758
- Sponsor's protocol ID
- CHUC_2023_94
- Acronym
- SoledadLP
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request. The data to be shared will include all IPD that underlie results in a publication, as well as the statistical analysis plan, informed consent form and the analytic code. All sensitive data will be anonymized to ensure the privacy and confidentiality of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Community Intervention in Reducing the Feeling of Unwanted Loneliness, Social Risk, and Social Isolation in the Population Over 65 Years Old in La Palma, Focusing on Healthy Habits, Sleep Hygiene, and Digital Literacy
- ClinicalTrials.gov ID
- NCT06829758
- Acronym / sponsor ID
- SoledadLP / CHUC_2023_94
- Conditions
- Loneliness
- Keywords
- Social Support, Community Health Nursing, Health Education, Aged
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Servicio Canario de SaludUniversity, hospital or other
- Collaborators
- University of La Laguna
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
Unwanted loneliness is the gap between the social relations a person has and those they want. The main objective of this research is to assess the impact of a multidimensional community-based intervention on the feeling of unwanted loneliness in the population over the age of 65 years old, who living alone, under social risk or socially isolated living in the La Palma island.
Detailed description
Loneliness is strongly associated with a significant impact on physical health, depression and may in fact be an independent risk factor for depression. Fur-thermore, it is negatively associated with healt problems, like higher blood pressure, poorer sleep, immune responses to stress, and poorer cognition over time in the elderly. The absence of personal connections is related to the adoption of worse life habits and to increased morbidity, with the consequent higher risk of suf-fering cardiovascular and endocrine diseases, mental health pathologies and risk of falls.
The secondary objectives proposed are as follows: Increasing the number of opportunities for social interaction during the intervention; Contributing tools to improve the participants' social skills in the intervention; Fostering self-care and healthy habits in the participants; Reducing maladaptive thoughts; Educating on sleep hygiene measures and non-pharmacological treatments.
The null hypothesis (H0) of this research is that in the population under study, the proposed multidimensional community intervention will not significantly impact the feeling of unwanted loneliness and the health management of these subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Compartiendo SaludThe intervention proposed (Compartiendo Salud) is a multicomponent intervention based on prevention and on promoting the health of older adults that live alone. Quasi-experimental study was designed with pre- and post- intervention (at three months) measurements, with no Control Group or randomisation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- People over the age of 65 and living alone
- Nursing diagnosis of social risk
- Nursing diagnosis of social isolation
Key exclusion criteria (4 listed)
- presenting moderate/severe cognitive decline or Pfeiffer scores above 6
- individuals with uncorrected hearing deficits that hinder group interaction
- participants not subjected to the pre- and post-interventions measurements
- participants that do not take part in at least four of the five sessions scheduled
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 |
|---|---|---|
| Compartiendo SaludThe intervention proposed (Compartiendo Salud) is a multicomponent intervention based on prevention and on promoting the health of older adults that live alone. The community-based intervention consists in five workshops that are carried out during a week (one day for each workshop). The sessions (which last 2.5 hours each) are designed in an expository and participatory way, using gaming dynamics that foster learning and social interaction. The content of the workshops is the same for all BHDs. Each workshop addresses risk factors that predispose the population to experiencing more unwanted loneliness and social isolation. The concepts corresponding to each of the five sessions that comprise the intervention are: Sleep hygiene, Healthy and sustainable eating habits, Physical activity and exercise, Memory and music therapy, Digital literacy | Behavioural | Intervention |
Primary outcome
Number of Participants with Feeling of unwanted loneliness
Time frame: Pre- and post- intervention (at three months)
It was measured using the "UCLA (University of California at Los Angeles) Loneliness scale" test validated in Spain. This instrument is based on three dimensions: Relational connection; Social connection; and Self-perceived isolation. It uses a 4-point scale ranging from "Never" to "Frequently" for responses 10 items. Scores above 30 correspond to "No loneliness", between 20 and 30 mean "Moderate loneliness" and less than 20 points is "Severe loneliness"
13 secondary outcomes
Number of Participants with Social risk
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Low Perceived social support
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Anxiety or depression
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Risk of loneliness
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Social Isolation
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Smoking
Time frame: Pre- and post- intervention (at three months)
Number of Participants with alcoholism
Time frame: Pre- and post- intervention (at three months)
Number of Participants without sleep problems
Time frame: Pre- and post- intervention (at three months)
Number of Participants with caregiver
Time frame: Pre- and post- intervention (at three months)
Number of Participants belonging to an organized group
Time frame: Pre- and post- intervention (at three months)
Number of Participants what does it feel like Integrated in the area where they live
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Activities in free and/or leisure time
Time frame: Pre- and post- intervention (at three months)
Number of Participants with Home-based care; Social assistance
Time frame: Pre- and post- intervention (at three months)
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 28 Feb 2025.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request. The data to be shared will include all IPD that underlie results in a publication, as well as the statistical analysis plan, informed consent form and the analytic code. All sensitive data will be anonymized to ensure the privacy and confidentiality of the participants.
Related trials for Loneliness
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
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.
Alba Francisco-Sánchez, Nursing Specialist principal investigator
Atención Primaria. Área de Salud de La Palma. Servicio Canario de Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compartiendo Salud in people with Loneliness, run by Servicio Canario de Salud 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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 Alba Francisco-Sánchez, Nursing Specialist (34922479460, afrasanb@gobiernodecanarias.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Feeling of unwanted loneliness (time frame: Pre- and post- intervention (at three months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.