TIVA Mobile Health Intervention for Family Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TIVA Mobile Application.
- Who it may be relevant to
- Registry conditions: Positive Mental Health, Family Caregivers, Mental Health Promotion, Caregiver Burden. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study
Overview
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.
Detailed description
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.
Interventions
- Behavioral TIVA Mobile Application
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.
Primary outcome measures
- Positive Mental Health [Time frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up]
Secondary outcome measures (1)
- Caregiver Burden [Time frame: Baseline, post-intervention at 4 weeks, and 3-month follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Portugal · 1 center
- University of Porto — Porto
Identifiers
NCT: NCT07616284 · TIVA-PILOT-2026