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Идёт набор NCT06829758

Compartiendo Salud: Community-Based Intervention for Loneliness

Без фазы С лечением Loneliness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Compartiendo Salud.
Кому может быть актуально
Состояния в реестре: Loneliness. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Number of Participants with Feeling of unwanted loneliness [Срок оценки: Pre- and post- intervention (at three months)]
Вторичные конечные точки (12)
  • Number of Participants with Social risk [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with Low Perceived social support [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with Anxiety or depression [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with Risk of loneliness [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with Social Isolation [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with Smoking [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with alcoholism [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants without sleep problems [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with caregiver [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants belonging to an organized group [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants what does it feel like Integrated in the area where they live [Срок оценки: Pre- and post- intervention (at three months)]
  • Number of Participants with Activities in free and/or leisure time [Срок оценки: Pre- and post- intervention (at three months)]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Испания · 1 центр
  • La Palma Health Area. Canary Islands Health Service. — Santa Cruz de La Palma

Идентификаторы

NCT: NCT06829758 · CHUC_2023_94

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗