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TIVA Mobile Health Intervention for Family Caregivers

NCT07616284 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Positive Mental Health
  • Family Caregivers
  • Mental Health Promotion
  • Caregiver Burden

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.

Sponsors & Collaborators

  • Instituto de Ciências Biomédicas Abel Salazar

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Sandra MT Carreira, PhD Student · Instituto de Ciências Biomédicas Abel Salazar

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616284 on ClinicalTrials.gov