Intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer
Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 (Kirby et al., 2024).
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Silvia Corchón, PhD
- Número de teléfono: 0034 963864182
- Correo electrónico: Silvia.Corchon@uv.es
Ubicaciones de estudio
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Valencia
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Valencia, Valencia, España, 46010
- University of Valencia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental group
The multimodal interventions includes:
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The multimodal intervention will include these activities:
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Sin intervención: No intervention group
This group will receive the ussual care in the day centers for familiar caregiver
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Score on the Jong Gierveld Lonelinss Scale
Periodo de tiempo: From the beginning of the enrollement until the end of the intervention at 12 weeks
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Loneliness Scale Social isolation will be measured with the Jong Gierveld Loneliness Scale. The final score is the total score for the 11 items, with the lowest possible score being 0 (no loneliness) and the highest being 11 (severe loneliness). Three categories have been proposed based on the score: a score of 0-2 points = no loneliness; a score of 3-8 points = moderate loneliness; and a score of 9-11 points = severe loneliness. |
From the beginning of the enrollement until the end of the intervention at 12 weeks
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Living with chronic conditions from the family perspective
Periodo de tiempo: From the enrollment to the end of the intervention at 12 weeks
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Living with LTCs scale from the perspective of the family caregiver (EC- PC- Fam).
This is an instrument adapted from the original EC- PC.29-31
The adaptation process of the instrument and prior pilot study have been previously described in detail.23
The validated version has 31 items and 5 domains: (1) acceptance, (2) coping, (3) self- management, (4) integration and (5) adaptation.
All the items follow a Likert scale of 5 points answer system, from never or none (0) to always and much (4), except for the items from the acceptance domain, which must be inverted to obtain results such as never or none (4) or always or much (0).
The scores range from 0 to 155, with a higher score indicating more positive living with LTCs.
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From the enrollment to the end of the intervention at 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Score in Goldberg Anxiety and Depression Scale.
Periodo de tiempo: From enrollement until the end of the intervention ar 12 weeks
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The symptoms of anxiety and depression will be measured with the Goldberg Anxiety and Depression Scale. This is a questionnaire that discriminates between the diagnosis of anxiety and depression and measures their retrospective intensities. It consists of two subscales: one for anxiety and one for depression. Each subscale is composed of 9 dichotomous response items (YES or NO) to determine whether the subject has had any of the indicated symptoms in the last two weeks. The cut-off points are 4 or more items or affirmative responses for the anxiety scale and 2 or more for the depression scale. The higher the score, the greater the severity of the problem, with a maximum possible score of 9 points for each subscale. |
From enrollement until the end of the intervention ar 12 weeks
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The score in the EuroQQL-5
Periodo de tiempo: From enrollement until the end of the intervention at 12 weeks
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The EuroQOL- 5 Dimensions 5- Level version (EQ- 5D- 5L) is an instrument designed to generically measure HRQOL, which can be used by both a healthy population and an individual with pathologies.
The instrument developed by the EUROQOL group32 has been validated in many countries, including Spain.33 34 Different versions can be found, and in the present study, the EQ- 5D- 5L was selected due to the increase in the specificity of the responses as compared with the EQ- 5D- 3L.
It is a self- administered instrument in which individuals assess their own health, first in a descriptive manner for each of the dimensions (mobility, personal care, everyday activities, pain/ discomfort and anxiety/depression), with five levels, from 0 to 5, and then with a more general Visual Analogical Scale.
For the Spanish context, the psycho metric properties of the EQ- 5D- 5L scale were analysed in patients35 with the results indicating a reliability of 0.86.
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From enrollement until the end of the intervention at 12 weeks
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Score in Zarit Test for caregiver burden
Periodo de tiempo: From enrollement until the end of the intervention at 12 weeks
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Zarit test: This scale is included to verify the external validity (divergent validity) of the EC- PC- Fam.
This scale, originally named Caregiver Burden Interview, is designed to assess the burden of caregivers of indi viduals with dementia, from the general theory of the items39.
It has 22 items that evaluate the negative repercussions on specific areas of daily life associated with caregiving: physical health, psychological health, social activities and economic resources.
As opposed to the original, the version validated in Spain40 includes a 5- point Likert scale, for a total score that ranges from 22 to 110.
In this study, different cut- off points were proposed: from 22 to 46, without burden; from 47 to 55, with burden and from 56 to 110, intense burden.
The scale obtained an internal consistency of 0.91 and test-retest reliability of 0.96.
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From enrollement until the end of the intervention at 12 weeks
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-ENFPOD-3741812
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Cuidadores familiares
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Ruijin HospitalAún no reclutandoDelirio | Sedación y Analgesia | Movilización Temprana | Family Invlovement/Empoderment