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Recruiting NCT06829758

Compartiendo Salud: Community-Based Intervention for Loneliness

No phase Interventional Loneliness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compartiendo Salud.
Who it may be relevant to
Registry conditions: Loneliness. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Compartiendo Salud
    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.

Primary outcome measures

  • Number of Participants with Feeling of unwanted loneliness [Time frame: Pre- and post- intervention (at three months)]
Secondary outcome measures (12)
  • 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Spain · 1 center
  • La Palma Health Area. Canary Islands Health Service. — Santa Cruz de La Palma

Identifiers

NCT: NCT06829758 · CHUC_2023_94

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗