Clinical trial NCT06829758: Compartiendo Salud: Community-Based Intervention for Loneliness
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: Social Support
Community Health Nursing
Health Education
Aged
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: University of La Laguna
First posted: 2025-02-17
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* People over the age of 65 and living alone
* Nursing diagnosis of social risk
* Nursing diagnosis of social isolation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants with Feeling of unwanted loneliness
timeFrame: Pre- and post- intervention (at three months)
Secondary outcomes:
measure: Number of Participants with Social risk
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Low Perceived social support
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Anxiety or depression
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Risk of loneliness
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Social Isolation
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Smoking
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with alcoholism
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants without sleep problems
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with caregiver
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants belonging to an organized group
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants what does it feel like Integrated in the area where they live
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Activities in free and/or leisure time
timeFrame: Pre- and post- intervention (at three months)
measure: Number of Participants with Home-based care; Social assistance
timeFrame: Pre- and post- intervention (at three months)
Other outcomes:
Locations:
city: Santa Cruz de La Palma
country: Spain
facility: La Palma Health Area. Canary Islands Health Service.
Study officials:
affiliation: Atención Primaria. Área de Salud de La Palma. Servicio Canario de Salud
name: Alba Francisco-Sánchez, Nursing Specialist
role: PRINCIPAL_INVESTIGATOR
References: