TIVA Mobile Health Intervention for Family Caregivers (NCT07616284) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TIVA Mobile Health Intervention for Family Caregivers
Portugal80 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive Mental Health
Timeframe: Baseline, post-intervention at 4 weeks, and 3-month follow-up