TIVA Mobile Health Intervention for Family Caregivers

Официальное название

A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Positive Mental Health [Срок оценки: Baseline, post-intervention at 4 weeks, and 3-month follow-up]

Вторичные конечные точки (1)

• Caregiver Burden [Срок оценки: Baseline, post-intervention at 4 weeks, and 3-month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Португалия · 1 центр

• University of Porto — Porto

Идентификаторы

NCT: NCT07616284 · TIVA-PILOT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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