Compartiendo Salud: Community-Based Intervention for Loneliness

NCT06829758 | Recruiting

• 1 other identifier: CHUC_2023_94
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Keywords

Social Support; Community Health Nursing; Health Education; Aged

Outcome Measures

Primary Outcomes (1)

• 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"

  Pre- and post- intervention (at three months)

Secondary Outcomes (13)

• Number of Participants with Social risk

  Pre- and post- intervention (at three months)

• Number of Participants with Low Perceived social support

  Pre- and post- intervention (at three months)

• Number of Participants with Anxiety or depression

  Pre- and post- intervention (at three months)

• Number of Participants with Risk of loneliness

  Pre- and post- intervention (at three months)

• Number of Participants with Social Isolation

  Pre- and post- intervention (at three months)

Study Arms (1)

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.

Behavioral: Compartiendo Salud

Interventions

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Servicio Canario de Salud: lead
• University of La Laguna: collaborator

Study Sites (1)

La Palma Health Area. Canary Islands Health Service.

Santa Cruz de La Palma, Spain

RECRUITING

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Alba Francisco-Sánchez, Nursing Specialist

  Atención Primaria. Área de Salud de La Palma. Servicio Canario de Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Francisco-Sánchez, Nursing Specialist

CONTACT

34922479460; afrasanb@gobiernodecanarias.org

Martín Rodríguez-Álvaro, PhD

CONTACT

34922479460; mrodrigu@ull.edu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The complete IPD will be available for sharing six months after the study's conclusion.
• Access Criteria: As an access criterion for Individual Participant Data (IPD), it is required that no information be requested that could compromise the anonymity of participants. This ensures adherence to ethical research standards and the protection of personal data, safeguarding the confidentiality and privacy of all individuals involved.

Locations

ES (1)