- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07821970
Finding With Nature: A Study Testing Nature-Based Support for Family Caregivers Aged 65 and Over (FWN)
Finding With Nature: A Nature-Based Intervention for the Well-Being of Family Caregivers Aged 65 and Over: Protocol for a Randomised Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
An intervention study in randomised control trial design will be conducted with a target sample of 350 participants living in Central Finland. After receiving information about the research and providing a written consent, participants answer a question of caregiver burden and indicate whether they would prefer to participate in the Finding with Nature (FWN) programme in face-to-face group meetings or individually via an interactive online platform. After that, the participants are randomly allocated to intervention and control groups which are balanced according to the caregiver burden. The participants in the intervention group will be offered a 6-week FWN programme either in a face-to-face group or individually online, according to their own preference. In the face-to-face group implementation, the FWN programme will be carried out by a trained facilitator with meetings once a week. In the online implementation, the FWN programme will be completed individually at their own pace via an interactive online platform. In both implementation formats, participants will complete independent tasks and have the opportunity to share their experiences with peers.
At the core of the FWN programme are facilitated nature-based, low-threshold exercises in six theme areas of the FWN programme (one theme for each week): 1) Introduction, personal situation, and starting points for change; 2) personally meaningful matters and values; 3) acceptance of emotions and confronting barriers; 4) listening to the body, meaningful movement, and natural settings; 5) mindfulness skills and everyday choices; and (6) self-concept, self-compassion, and self-awareness.
Participants respond to surveys at three measurement points: a pre-measurement at the start of the programme, a post-measurement at the end of the programme, and a follow-up measurement three months after the end of the programme. The participants in the intervention group are compared to the participants in the control group who continue life as usual and only respond to online surveys at three measurement points (pre-, post- and follow-up measurements). The control group participants are offered a opportunity to participate in face-to-face group meetings or the online implementation of the FWN programme after the follow-up measurement.
This research is funded by the Health Promotion Grant (Ministry of Social Affairs and Health, STM, va-thl-2025-1-80).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Julija Chichaeva, MHS
- Número de teléfono: +358504628081
- Correo electrónico: julija.chichaeva@jamk.fi
Copia de seguridad de contactos de estudio
- Nombre: Emmi Matikainen, PhD
- Número de teléfono: +358504755530
- Correo electrónico: emmi.matikainen-tervola@jamk.fi
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 65 years and older
- Providing care for a close one, formally or informally
- Able to communicate adequately in Finnish
- Willingness to commit to a 6-week intervention programme
Exclusion Criteria:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Finding with Nature intervention
Participants aged ≥65 years who are informal/family caregivers and living in Central Finland.
Participants randomized to this arm will take part in a 6-week structured intervention program.
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A 6-week nature-based program integrating physical activity in nature and Acceptance and Commitment Therapy (ACT) methods to promote well-being, functioning, and nature connectedness.
Delivered either in face-to-face groups or via an online platform, including guided sessions, independent exercises, informational content, and opportunities for peer support.
|
|
Sin intervención: No intervention
Participants aged ≥65 years who are informal/family caregivers and living in Central Finland.
Participants randomized to this arm will continue their usual daily life without the study intervention during the 6-week follow-up period.
After the follow-up, they will be offered the opportunity to participate in the intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Psychological well-being: the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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7-item scale, range 7-35; higher scores indicate better mental well-being.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregivers' perceived coping as caregivers: COPE Index
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
COPE Index evaluates the caregiver's subjective experience of strain, support, and quality of the caregiving relationship.
15-item scale, range 15-75; higher scores indicate greater caregiving burden.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Functioning: the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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A standardized assessment of functioning across multiple life domains.
12-item scale, range 0-48; higher scores indicate greater disability (worse functioning).
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Adult Social Care Outcomes Toolkit (ASCOT) SCT4
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Measure designed specifically for informal caregivers, focusing on social care-related quality of life.
8-item scale; higher scores indicate better social care-related quality of life.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Self-rated health: a single validated item
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Connectedness to nature: short version of Connectedness to Nature Scale (CNS)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Short version of the Connectedness to Nature Scale (CNS), 7-item scale, range 7-35; higher scores indicate greater connectedness to nature.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Connectedness to nature and nature-related experiences: the Holistic Nature Experience measure
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
16-item scale, range 16-96; higher scores indicate more positive nature-related experiences.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Psychological flexibility: Comprehensive Assessment of ACT Processes (CompACT-10)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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10-item scale, range 0-60; higher scores indicate greater psychological flexibility
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Anxiety: Generalized Anxiety Disorder 7-item Scale (GAD-7)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
7-item scale, range 0-21; higher scores indicate greater anxiety symptoms
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Physical activity: International physical activity questionnaire -short form (IPAQ-SF)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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International Physical Activity Questionnaire - Short Form (IPAQ-SF), 7-item questionnaire.
Total physical activity is expressed as MET-minutes per week.
The minimum value is 0 MET-minutes/week, with no fixed maximum value.
Higher scores indicate higher levels of physical activity.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Restorative experiences: the Restoration Outcome Scale (ROS)
Periodo de tiempo: Immediately before and after each of the six weekly intervention sessions during the 6-week intervention period.
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6-item scale, range 6-42; higher scores indicate greater restorative experiences
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Immediately before and after each of the six weekly intervention sessions during the 6-week intervention period.
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Life-space mobility: the Life-Space Assessment (LSA)
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Capture the spatial extent and frequency of participants' mobility in daily life, assessing mobility over the previous 4 weeks, range 0-120; higher scores indicate greater life-space mobility
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Engagement with natural and green environments
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Assessed through questions on frequency, purpose, and patterns of nature visits.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregiver characteristics
Periodo de tiempo: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Information is collected on the care recipient, duration of caregiving, formal caregiver status, and use of support services.
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Pre-intervention, immediately post-intervention, and 3-month follow-up.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julija Chichaeva, MHS, JAMK University Of Applied Sciences
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
- VA-THL-2025-1-80
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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