Intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer

Официальное название

Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease

Обзор

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness and improve the living with process of family caregivers of people with Alzheimer disease through multiple interventions (music therapy, health education)

Подробное описание

This project proposes a multimodal and interdisciplinary intervention aimed at alleviating or reducing unwanted loneliness and improving the living with process of family caregivers of individuals with Alzheimer's disease (AD). In doing so, it seeks to enhance their health and overall quality of life. The intervention will include activities such as health education, physical activity and music therapy.

The interdisciplinary team will also incorporate citizen participation, specifically through the involvement of an individual who has previously been a family caregiver of a person with AD. There is a growing body of evidence indicating that citizen participation in healthcare is highly advisable, as it is expected to improve the quality and relevance of outcomes.

This is a prospective, longitudinal, analytical, and experimental study.

The proposed study will involve different groups and the program will last for a total of 12 weeks. The program will include the following activities:

Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.

Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, Alzheimer disease, among others.

Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions

Вмешательства

• Поведенческое Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer
  The multimodal intervention will include these activities: 1. Health education workshops 2. Music therapy sessions 3. Physical exercise adapted to the physical conditions of each participant.

Первичные конечные точки

• Score on the Jong Gierveld Lonelinss Scale [Срок оценки: From the beginning of the enrollement until the end of the intervention at 12 weeks]
• Living with chronic conditions from the family perspective [Срок оценки: From the enrollment to the end of the intervention at 12 weeks]

Вторичные конечные точки (3)

• Score in Goldberg Anxiety and Depression Scale. [Срок оценки: From enrollement until the end of the intervention ar 12 weeks]
• The score in the EuroQQL-5 [Срок оценки: From enrollement until the end of the intervention at 12 weeks]
• Score in Zarit Test for caregiver burden [Срок оценки: From enrollement until the end of the intervention at 12 weeks]

Критерии участия

Критерии включения

• Family caregivers of people with Alzheimer's disease (AD).
• Primary family caregivers who live with the person with AD.
• The person with AD must be enrolled in one of the adult day care centers where the study is conducted.
• Ability to communicate in Spanish and/or Valencian.

Критерии исключения

• Presence of moderate or severe cognitive impairment, mental disorder, significant sensory impairment, disabling chronic illness, or any medical condition that contraindicates participation in any of the study activities.
• Family caregivers of institutionalized individuals.
• Family caregivers of people with AD who have died.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Испания · 1 центр

• University of Valencia — Valencia

Публикации

• Marin-Maicas P, Portillo MC, Corchon S, Ambrosio L. Methodological Proposal for the Adaptation of the Living with Long-Term Conditions Scale to the Family Caregiver. Nurs Rep. 2024 Feb 27;14(1):532-544. doi: 10.3390/nursrep14010041. PMID 38535713
• Mafla-Espana MA, Corchon S, Jimeno-de Pedro P, Ibanez-Del Valle V, Cauli O. Social and Mental Health Factors Involved in the Severity of Loneliness in Older Individuals in a Spanish Rural Area. Nurs Rep. 2024 Nov 29;14(4):3737-3753. doi: 10.3390/nursrep14040273. PMID 39728634
• Marin-Maicas P, Ambrosio L, Corchon S, Gonzalez-Moreno J, Portillo MC. Living with long-term conditions: validation of a new instrument for family caregivers in a Spanish-speaking population. BMJ Open. 2024 Sep 20;14(9):e088773. doi: 10.1136/bmjopen-2024-088773. PMID 39306353
• Sanchez-Martinez V, Cauli O, Corchon S. Long-Term Caregiving Impact and Self-Care Strategies in Family Caregivers of People with Neuropsychiatric Disorders: A Mixed-Method Study. Diseases. 2024 Nov 14;12(11):292. doi: 10.3390/diseases12110292. PMID 39589966
• Marin-Maicas P, Corchon S, Ambrosio L, Portillo MC. Living with Long Term Conditions from the Perspective of Family Caregivers. A Scoping Review and Narrative Synthesis. Int J Environ Res Public Health. 2021 Jul 8;18(14):7294. doi: 10.3390/ijerph18147294. PMID 34299745
• Ibanez-Del Valle V, Corchon S, Zaharia G, Cauli O. Social and Emotional Loneliness in Older Community Dwelling-Individuals: The Role of Socio-Demographics. Int J Environ Res Public Health. 2022 Dec 10;19(24):16622. doi: 10.3390/ijerph192416622. PMID 36554512
• Zaharia G, Ibanez-Del Valle V, Cauli O, Corchon S. The Long-Lasting Effect of Multidisciplinary Interventions for Emotional and Social Loneliness in Older Community-Dwelling Individuals: A Systematic Review. Nurs Rep. 2024 Dec 6;14(4):3847-3863. doi: 10.3390/nursrep14040281. PMID 39728642

Идентификаторы

NCT: NCT07639645 · 2024-ENFPOD-3741812

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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