- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Julija Chichaeva, MHS
- Numéro de téléphone: +358504628081
- E-mail: julija.chichaeva@jamk.fi
Sauvegarde des contacts de l'étude
- Nom: Emmi Matikainen, PhD
- Numéro de téléphone: +358504755530
- E-mail: emmi.matikainen-tervola@jamk.fi
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Psychological well-being: the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
7-item scale, range 7-35; higher scores indicate better mental well-being.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Caregivers' perceived coping as caregivers: COPE Index
Délai: 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.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Functioning: the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
A standardized assessment of functioning across multiple life domains.
12-item scale, range 0-48; higher scores indicate greater disability (worse functioning).
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Adult Social Care Outcomes Toolkit (ASCOT) SCT4
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
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.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Self-rated health: a single validated item
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
|
Connectedness to nature: short version of Connectedness to Nature Scale (CNS)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Short version of the Connectedness to Nature Scale (CNS), 7-item scale, range 7-35; higher scores indicate greater connectedness to nature.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Connectedness to nature and nature-related experiences: the Holistic Nature Experience measure
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
16-item scale, range 16-96; higher scores indicate more positive nature-related experiences.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Psychological flexibility: Comprehensive Assessment of ACT Processes (CompACT-10)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
10-item scale, range 0-60; higher scores indicate greater psychological flexibility
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Anxiety: Generalized Anxiety Disorder 7-item Scale (GAD-7)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
7-item scale, range 0-21; higher scores indicate greater anxiety symptoms
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Physical activity: International physical activity questionnaire -short form (IPAQ-SF)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
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.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Restorative experiences: the Restoration Outcome Scale (ROS)
Délai: Immediately before and after each of the six weekly intervention sessions during the 6-week intervention period.
|
6-item scale, range 6-42; higher scores indicate greater restorative experiences
|
Immediately before and after each of the six weekly intervention sessions during the 6-week intervention period.
|
|
Life-space mobility: the Life-Space Assessment (LSA)
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
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
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
|
Engagement with natural and green environments
Délai: Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Assessed through questions on frequency, purpose, and patterns of nature visits.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Caregiver characteristics
Délai: 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.
|
Pre-intervention, immediately post-intervention, and 3-month follow-up.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Julija Chichaeva, MHS, JAMK University Of Applied Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VA-THL-2025-1-80
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .