TIVA Mobile Health Intervention for Family Caregivers (TIVA-Pilot)
A Mobile Health Intervention for the Promotion of Mental Health in Family Caregivers: Protocol for a Pilot Study
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sandra MT Carreira, PhD Student
- 电话号码：962189453
- 邮箱：sandracarreira30@gmail.com
学习地点
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Porto District
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Porto、Porto District、葡萄牙
- University of Porto
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接触：
- Sandra MT Carreira, PhD Student
- 电话号码：962189453
- 邮箱：sandracarreira30@gmail.com
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接触：
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首席研究员：
- Sandra MT Carreira, PhD Student
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TIVA Intervention
Behavioral: TIVA Mobile Application
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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.
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无干预：Usual Care
Active Comparator
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Positive Mental Health
大体时间：Baseline, post-intervention at 4 weeks, and 3-month follow-up
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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] |
Baseline, post-intervention at 4 weeks, and 3-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Caregiver Burden
大体时间：Baseline, post-intervention at 4 weeks, and 3-month follow-up
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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.
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Baseline, post-intervention at 4 weeks, and 3-month follow-up
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Usability of the TIVA Mobile Application
大体时间：Post-intervention at 4 weeks
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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.
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Post-intervention at 4 weeks
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Satisfaction With the TIVA Mobile Application
大体时间：Post-intervention at 4 weeks.
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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.
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Post-intervention at 4 weeks.
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Adherence
大体时间：During the 4-week intervention period.
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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.
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During the 4-week intervention period.
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Acceptability of the TIVA Intervention
大体时间：Post-intervention at 4 weeks.
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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.
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Post-intervention at 4 weeks.
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合作者和调查者
调查人员
- 首席研究员：Sandra MT Carreira, PhD Student、Instituto de Ciências Biomédicas Abel Salazar
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TIVA-PILOT-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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