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TIVA Mobile Health Intervention for Family Caregivers (TIVA-Pilot)

29. maj 2026 opdateret af: Universidade do Porto

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TIVA Intervention
Behavioral: TIVA Mobile Application
Adfærdsmæssigt: 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.
Ingen indgriben: Usual Care
Active Comparator

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive Mental Health
Tidsramme: Baseline, post-intervention at 4 weeks, and 3-month follow-up

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Caregiver Burden
Tidsramme: Baseline, post-intervention at 4 weeks, and 3-month follow-up
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.
Baseline, post-intervention at 4 weeks, and 3-month follow-up

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Usability of the TIVA Mobile Application
Tidsramme: Post-intervention at 4 weeks
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.
Post-intervention at 4 weeks
Satisfaction With the TIVA Mobile Application
Tidsramme: Post-intervention at 4 weeks.
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.
Post-intervention at 4 weeks.
Adherence
Tidsramme: During the 4-week intervention period.
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.
During the 4-week intervention period.
Acceptability of the TIVA Intervention
Tidsramme: Post-intervention at 4 weeks.
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.
Post-intervention at 4 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidade do Porto

Samarbejdspartnere

Instituto de Ciências Biomédicas Abel Salazar

Efterforskere

  • Ledende efterforsker: Sandra MT Carreira, PhD Student, Instituto de Ciências Biomédicas Abel Salazar

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TIVA-PILOT-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly shared due to privacy, ethical, and data protection considerations. Aggregated study results may be made available upon reasonable request and in accordance with institutional and ethical regulations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Placeringer

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