Digital Structured Assessment in Older Patients With Acute Leukemia: Clinical Impact

May 13, 2026 updated by: Teresa Bernal del Castillo, Fundación para la Investigación Biosanitaria del Principado de Asturias

Clinical Impact and Feasibility of the Digital Implementation of a Structured Assessment in Patients ≥65 Years With Acute Leukemia: A Prospective Pilot Study

This pilot study evaluates the feasibility and preliminary clinical impact of digitally implementing a structured assessment in adults aged ≥65 years with acute leukemia receiving ambulatory follow-up care. Participants will complete validated quality-of-life and clinical questionnaires remotely through the institutional digital platform (MiAsturSalud/SESPA). The study examines adherence, usability, caregiver support needs, changes in quality of life, and variations in healthcare resource utilization after digitalization of the assessment process.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥65 years.
  • Confirmed diagnosis of acute leukemia.
  • Active ambulatory follow-up in the Hematology Service.
  • Ability to complete questionnaires independently or with caregiver support.
  • Access to a compatible digital device (patient or caregiver).
  • Signed informed consent.

Exclusion Criteria:

  • Severe cognitive impairment preventing participation (per clinical judgment and baseline screening).
  • Terminal clinical condition with limited life expectancy.
  • Non-resolvable technical impossibility of digital access.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Structure Assessment Pathway
Other: Digital Structured Assessment Implementation
Integration of a structured set of validated clinical and patient-reported outcome questionnaires into the MiAsturSalud/SESPA digital platform for remote completion by older adults with acute leukemia. After a brief baseline visit, patients receive instructions and complete the EORTC QLQ-C30, FACT-Leu, and related measures at home within 48-72 hours, with a second digital assessment at 3-6 months. The system automatically records adherence, completion time, and caregiver support needs. All data are incorporated into routine clinical workflows. DSAI does not modify treatment or include automated alerts; its purpose is to evaluate feasibility, usability, and preliminary clinical impact of digitalizing structured assessments in real-world hematology practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Digital Implementation
Time Frame: Within 7 days after baseline.
Proportion of participants completing ≥80% of the digital assessment battery after the baseline visit.
Within 7 days after baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Support Requirement
Time Frame: Within 7 days after baseline.
Proportion of participants requiring caregiver assistance to complete the digital battery.
Within 7 days after baseline.
Dropout Rate
Time Frame: From baseline to 3-6 months.
Percentage of participants who discontinue digital follow-up.
From baseline to 3-6 months.
Time Required for Digital Completion
Time Frame: Within 7 days after baseline.
Mean time (minutes) required to complete the digital questionnaires.
Within 7 days after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected in this study will not be made publicly available due to the small sample size and the potential risk of participant identification. De-identified data underlying the results reported in future publications may be made available from the corresponding author upon reasonable request, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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