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| Name | Class |
|---|---|
| Instituto de Ciências Biomédicas Abel Salazar | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA Intervention | Experimental | Behavioral: TIVA Mobile Application |
|
| Usual Care | No Intervention | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA Mobile Application | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Mental Health | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Burden | 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. | Baseline, post-intervention at 4 weeks, and 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the TIVA Mobile Application | 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. | Post-intervention at 4 weeks |
| Satisfaction With the TIVA Mobile Application |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra MT Carreira, PhD Student | Contact | 962189453 | sandracarreira30@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandra MT Carreira, PhD Student | Instituto de Ciências Biomédicas Abel Salazar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Porto | Porto | Porto District | Portugal |
Individual participant data will not be publicly shared due to privacy, ethical, and data protection considerations. Aggregated study results may be made available upon reasonable request and in accordance with institutional and ethical regulations.
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Participants will be randomly assigned in a 1:1 ratio to either the TIVA intervention group or the usual care control group. The intervention group will use the TIVA mobile application for four weeks, while the control group will receive usual care. Outcomes will be assessed at baseline, post-intervention, and follow-up.
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This is an open-label study. Participants and researchers will be aware of group allocation due to the nature of the intervention.
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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. |
| Post-intervention at 4 weeks. |
| Adherence | 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. | During the 4-week intervention period. |
| Acceptability of the TIVA Intervention | 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. | Post-intervention at 4 weeks. |