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NCT Number: NCT06829758

Compartiendo Salud: Community-Based Intervention for Loneliness

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Palma Health Area. Canary Islands Health Service.

Santa Cruz de La Palma, Spain

Location status: Recruiting

Location contact

Martín Rodríguez-Álvaro, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compartiendo Salud

Behavioral

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

Primary outcomes

  1. 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"

Secondary outcomes

  1. Number of Participants with Social risk

    Time frame: Pre- and post- intervention (at three months)

    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

  2. Number of Participants with Low Perceived social support

    Time frame: Pre- and post- intervention (at three months)

    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"

  3. Number of Participants with Anxiety or depression

    Time frame: Pre- and post- intervention (at three months)

    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

  4. Number of Participants with Risk of loneliness

    Time frame: Pre- and post- intervention (at three months)

    Nursing diagnosis "Risk of loneliness" (Yes/No) and presence/absence of each of its defining characteristics: Affective deprivation; Emotional Deprivation; Physical isolation; Social isolation.

  5. Number of Participants with Social Isolation

    Time frame: Pre- and post- intervention (at three months)

    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.

  6. Number of Participants with Smoking

    Time frame: Pre- and post- intervention (at three months)

    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

  7. Number of Participants with alcoholism

    Time frame: Pre- and post- intervention (at three months)

    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

  8. Number of Participants without sleep problems

    Time frame: Pre- and post- intervention (at three months)

    Sleep problem (Yes/No)

  9. Number of Participants with caregiver

    Time frame: Pre- and post- intervention (at three months)

    Dichotomous variables (Yes/No)

  10. Number of Participants belonging to an organized group

    Time frame: Pre- and post- intervention (at three months)

    Dichotomous variables (Yes/No)

  11. Number of Participants what does it feel like Integrated in the area where they live

    Time frame: Pre- and post- intervention (at three months)

    Dichotomous variables (Yes/No)

  12. Number of Participants with Activities in free and/or leisure time

    Time frame: Pre- and post- intervention (at three months)

    Dichotomous variables (Yes/No)

  13. Number of Participants with Home-based care; Social assistance

    Time frame: Pre- and post- intervention (at three months)

    Dichotomous variables (Yes/No)

Study contacts

Contact information is provided by the study sponsor or research team.

Alba Francisco-Sánchez, Nursing Specialist

CONTACT

[email protected]

34922479460

Martín Rodríguez-Álvaro, PhD

CONTACT

[email protected]

34922479460

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Collaborators

  • University of La Laguna

Registry information

Official study 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

Acronym: SoledadLP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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