TIVA Mobile Health Intervention for Family Caregivers (TIVA-Pilot)
A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study
This pilot study aims to evaluate the feasibility, usability, and preliminary effects of the TIVA mobile health intervention in promoting positive mental health among family caregivers of older adults. TIVA is a culturally adapted mobile application based on Lluch's Positive Mental Health model and designed to support caregivers through daily activities, motivational messages, relaxation strategies, and psychoeducational content over a four-week intervention period.
A pilot randomized controlled study with parallel allocation will be conducted involving family caregivers recruited in community and primary healthcare settings in Portugal. Participants will be allocated either to the TIVA intervention group or to a usual care control group. Outcomes will include positive mental health, caregiver burden, usability, satisfaction, adherence, and acceptability. Data will be collected at baseline, post-intervention, and follow-up.
This study intends to contribute to the development of accessible digital mental health strategies to support family caregivers and promote healthy ageing.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This pilot randomized controlled trial aims to evaluate the feasibility, usability, acceptability, and preliminary effects of the TIVA mobile health intervention designed to promote positive mental health among family caregivers of older adults.
The TIVA intervention is a culturally adapted mobile application based on Lluch's Positive Mental Health model and derived from the Spanish "Cuidadoras Crónicos" program. The intervention includes daily psychoeducational content, motivational messages, relaxation exercises, and activities focused on emotional well-being, autonomy, interpersonal relationships, problem-solving, and self-care over a four-week period.
Family caregivers will be recruited from community and primary healthcare settings in Portugal. Eligible participants will be randomly allocated in a 1:1 ratio to either the intervention group (TIVA app plus usual care) or the control group (usual care only). Due to the nature of the intervention, participant blinding will not be feasible.
Data collection will occur at baseline (T0), immediately after the intervention period (T1), and at follow-up (T2). Outcomes will include positive mental health, caregiver burden, usability, satisfaction, adherence, and acceptability. Positive mental health will be assessed using the Positive Mental Health Questionnaire, and caregiver burden will be evaluated using the Zarit Burden Interview.
This study seeks to contribute to the development of accessible digital mental health strategies for family caregivers and to support healthy ageing policies and community-based care.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sandra MT Carreira, PhD Student
- Numéro de téléphone: 962189453
- E-mail: sandracarreira30@gmail.com
Lieux d'étude
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Porto District
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Porto, Porto District, Le Portugal
- University of Porto
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Contact:
- Sandra MT Carreira, PhD Student
- Numéro de téléphone: 962189453
- E-mail: sandracarreira30@gmail.com
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Contact:
- E-mail: sandracarreira30@gmail.com
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Chercheur principal:
- Sandra MT Carreira, PhD Student
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18 years or older.
- Unpaid family caregivers of a person with chronic illness, disability, or dependency.
- Providing regular caregiving assistance for at least 4 months.
- Living in Portugal.
- Ability to read and understand Portuguese.
- Ownership and use of a smartphone with internet access compatible with the TIVA mobile application.
- Willingness to install and use the TIVA app for 4 weeks.
- Ability to provide informed consent.
Exclusion Criteria:
- Severe cognitive impairment.
- difficulties preventing independent use of the application or completion of study assessments.
- Severe psychiatric disorder or acute mental health crisis interfering with participation.
- Participation in another structured caregiver support or psychological intervention during the study period.
- Inability to use a smartphone independently.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: TIVA Intervention
Behavioral: TIVA Mobile Application
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The intervention consists of the use of the TIVA mobile application over a four-week period.
The application was culturally adapted for Portuguese family caregivers and is based on Lluch's Positive Mental Health model.
The app includes daily activities, motivational messages, relaxation exercises, psychoeducational content, and self-reflection strategies aimed at promoting positive mental health and well-being among family caregivers of older adults.
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Aucune intervention: Usual Care
Active Comparator
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Positive Mental Health
Délai: Baseline, post-intervention at 4 weeks, and 3-month follow-up
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Positive Mental Health assessed using the Positive Mental Health Questionnaire (PMHQ). The PMHQ total score ranges from 39 to 156, with higher scores indicating better positive mental health, emotional well-being, autonomy, interpersonal relationship skills, self-control, and problem-solving ability. Lower scores indicate lower levels of positive mental health. [Time Frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up] |
Baseline, post-intervention at 4 weeks, and 3-month follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Caregiver Burden
Délai: Baseline, post-intervention at 4 weeks, and 3-month follow-up
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Caregiver burden assessed using the Zarit Burden Interview (ZBI).
Total scores range from 0 to 88, with higher scores indicating higher levels of perceived caregiver burden, stress, and emotional overload associated with the caregiving role.
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Baseline, post-intervention at 4 weeks, and 3-month follow-up
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Usability of the TIVA Mobile Application
Délai: Post-intervention at 4 weeks
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Usability of the TIVA mobile application assessed using the System Usability Scale (SUS).
SUS scores range from 0 to 100, with higher scores indicating greater usability, accessibility, and user satisfaction with the mobile application.
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Post-intervention at 4 weeks
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Satisfaction With the TIVA Mobile Application
Délai: Post-intervention at 4 weeks.
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User satisfaction assessed using a TIVA-specific satisfaction questionnaire based on Likert-scale items.
Higher scores indicate greater satisfaction, usability, acceptability, and perceived usefulness of the TIVA mobile application.
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Post-intervention at 4 weeks.
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Adherence
Délai: During the 4-week intervention period.
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Adherence to the TIVA intervention assessed through in-app usage data, including frequency of logins, percentage of completed daily activities, and sustained participation throughout the 4-week intervention period.
Higher adherence indicates greater engagement and continued use of the TIVA mobile application.
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During the 4-week intervention period.
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Acceptability of the TIVA Intervention
Délai: Post-intervention at 4 weeks.
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Acceptability of the TIVA intervention assessed through participant-reported perceptions of usefulness, relevance, satisfaction, and willingness to continue or recommend the intervention.
Higher scores indicate greater acceptability and perceived value of the TIVA mobile application.
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Post-intervention at 4 weeks.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sandra MT Carreira, PhD Student, Instituto de Ciências Biomédicas Abel Salazar
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
- TIVA-PILOT-2026
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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