TIVA Mobile Health Intervention for Family Caregivers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade do Porto
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TIVA Mobile Application
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: TIVA InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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. \[Time Frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up\]
Time frame
Baseline, post-intervention at 4 weeks, and 3-month follow-upSecondary outcomes
1
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.
Time frame
Baseline, post-intervention at 4 weeks, and 3-month follow-upOther outcomes
1
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.
Time frame
Post-intervention at 4 weeks2
Satisfaction With the TIVA Mobile Application
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.
Time frame
Post-intervention at 4 weeks.3
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.
Time frame
During the 4-week intervention period.4
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.
Time frame
Post-intervention at 4 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade do Porto
Lead sponsor
Instituto de Ciências Biomédicas Abel Salazar
Collaborator
Source ClinicalTrials.gov
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