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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Sandra MT Carreira, PhD Student
- Puhelinnumero: 962189453
- Sähköposti: sandracarreira30@gmail.com
Opiskelupaikat
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Porto District
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Porto, Porto District, Portugali
- University of Porto
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Ottaa yhteyttä:
- Sandra MT Carreira, PhD Student
- Puhelinnumero: 962189453
- Sähköposti: sandracarreira30@gmail.com
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Ottaa yhteyttä:
- Sähköposti: sandracarreira30@gmail.com
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Päätutkija:
- Sandra MT Carreira, PhD Student
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Ei väliintuloa: Usual Care
Active Comparator
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Positive Mental Health
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Caregiver Burden
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Usability of the TIVA Mobile Application
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Sandra MT Carreira, PhD Student, Instituto de Ciências Biomédicas Abel Salazar
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- TIVA-PILOT-2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
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