Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

4. august 2026 opdateret af: Teresa Bernal del Castillo, Fundación para la Investigación Biosanitaria del Principado de Asturias

Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study

This pilot study will evaluate the feasibility of implementing a structured digital patient-reported assessment pathway in adults aged 65 years or older with acute leukemia. Following activation of the institutional MiAsturSalud/SESPA platform, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit and will repeat the digital assessment at 3-6 months. The primary outcome will be completion of at least 80% of the baseline digital assessment within 7 days. Secondary outcomes will be caregiver assistance requirement, non-completion of the planned digital follow-up assessment, and elapsed completion time. The study is not designed to establish clinical efficacy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Spanien
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spanien, 33011
        • Hospital Universitario Central de Asturias (HUCA)

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

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 65 years or older.
  • Confirmed diagnosis of acute leukemia of myeloid or lymphoid origin.
  • Active ambulatory follow-up in the Hematology Service at Hospital Universitario Central de Asturias.
  • Ability to understand the questionnaires and provide their own responses, independently or with practical assistance from a caregiver.
  • Access to a compatible internet-enabled digital device, either personally or through a caregiver.
  • Provision of written informed consent.

Exclusion Criteria:

  • Cognitive impairment that, in the treating hematologist's clinical judgment, prevents the participant from understanding the questionnaires or providing their own responses, despite permitted practical assistance from a caregiver.
  • Clinical condition that, in the treating hematologist's judgment, precludes completion of the study procedures.
  • Persistent inability to access or use the MiAsturSalud/SESPA platform despite reasonable technical support.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Digital Patient-Reported Assessment Pathway
Andet: Digital Patient-Reported Assessment Pathway
Following activation of the MiAsturSalud/SESPA digital pathway, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit. The baseline digital assessment will be scheduled within 48-72 hours, with an outcome assessment window extending to 7 days. A second digital assessment will be scheduled at 3-6 months. The platform will record questionnaire completion status and elapsed completion time, and caregiver assistance will be documented. The pathway will not generate automated clinical alerts or mandate changes to treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Digital Implementation
Tidsramme: Within 7 days after baseline.
Proportion of participants completing at least 80% of all required items across the EORTC QLQ-C30 and FACT-Leu baseline digital questionnaire battery.
Within 7 days after baseline.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Caregiver Assistance Requirement
Tidsramme: Within 7 days after baseline.
Proportion of participants requiring practical caregiver assistance to access or navigate the platform, read questionnaire content or enter responses selected by the participant. Independent proxy completion will not be permitted.
Within 7 days after baseline.
Non-completion of Planned Digital Follow-up Assessment
Tidsramme: From baseline to 3-6 months.
Proportion of participants who do not complete the planned digital follow-up assessment at 3-6 months. Reasons for non-completion will be categorised where ascertainable, including voluntary withdrawal, technical difficulties, clinical deterioration, disease progression, hospitalisation, death and loss to follow-up.
From baseline to 3-6 months.
Time Required for Digital Completion
Tidsramme: Within 7 days after baseline.
Elapsed time, in minutes, required to complete the baseline digital questionnaires.
Within 7 days after baseline.

Samarbejdspartnere og efterforskere

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

Sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Samarbejdspartnere

Otsuka Pharmaceutical Co., Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. december 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025.519

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying results reported in publications arising from this study, together with the corresponding data dictionary and statistical analysis code, will be available from the principal investigators upon reasonable request. Access will be subject to a methodologically sound proposal, institutional governance review, an appropriate data-use agreement and applicable ethics and data-protection requirements. Owing to the small sample size and risk of re-identification, participant-level data will not be deposited in an openly accessible public repository.

IPD-delingstidsramme

Beginning 6 months after publication of the principal study results and ending 5 years thereafter.

IPD-delingsadgangskriterier

Requests must include a methodologically sound research proposal and will be subject to approval by the principal investigators and relevant institutional governance bodies. Access will require an appropriate data-use agreement and compliance with applicable ethics and data-protection requirements

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner