Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06615349

DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care

Led by David Blum · Updated on 2025-07-10

382

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

D

David Blum

Lead Sponsor

Z

Zurich University of Applied Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to test whether a system using a wearable device that measures heartbeats and steps, combined with daily communication through a smartphone chatbot about symptoms and tips, can reduce unplanned hospital readmissions and improve well-being in patients with advanced cancer or other severe illnesses receiving palliative care. The study addresses the challenges of managing symptoms and preventing avoidable hospital visits for patients discharged from palliative care wards. It explores a digital approach to support patients' self-management and sense of security alongside standard care. Participants are randomly assigned to one of two groups: one group receives standard care plus the DigiPall intervention, which includes a sensor-equipped wearable and daily chatbot interactions via WhatsApp on their smartphone; the other group receives standard care alone. The intervention gathers continuous biomarker data and asks patients about their health status daily, providing automated feedback aligned with their existing treatment plans. This approach aims to support patients' adherence to their care plans and reduce rehospitalizations. During the study, participants will be monitored over several months. Researchers will track rates of unplanned rehospitalizations and emergency visits over 84 days, as well as quality of life and sense of security over 91 days, using specific questionnaires. Survival will also be observed over one year. The study includes regular assessments, with patient input integrated into the study design. Participation involves wearing the device, engaging with the chatbot daily, and attending scheduled evaluations to measure outcomes and safety.

CONDITIONS

Brief Title

DigiPall; a Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with an established diagnosis of metastatic cancer or severe illness with limited life expectancy receiving palliative care services
  • Estimated life expectancy less than 24 months but more than 3 months as judged by a physician
  • Karnofsky Index of 50% or higher, or ECOG performance status of 2 or less
  • Aged over 18 years
  • Owns and uses a smartphone
  • Provides written informed consent
Not Eligible

You will not qualify if you...

  • Patients currently receiving curative treatment
  • Relevant cognitive impairment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Outpatient Treatment

Duration - Approximately 12 weeks

Participants receive standard palliative care, with some using the DigiPall system combining a wearable sensor and a smartphone chatbot for daily symptom and biomarker monitoring to support self-management.

Daily digital interactions via smartphone and wearable monitoring during this period

Follow-up

Duration - Up to 12 months

Participants are observed for survival and other outcomes up to one year after treatment.

Periodic assessments as part of study follow-up

Trial Site Locations

Total: 1 location

1

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

D

David Blum, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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https://pubmed.ncbi.nlm.nih.gov/25877944

Symptom and quality of life survey of medical oncology patients at a veterans affairs medical center: a role for symptom assessment.

V T Chang, S S Hwang, M Feuerman...

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What bothers lung cancer patients the most? A prospective, longitudinal electronic patient-reported outcomes study in advanced non-small cell lung cancer.

Thomas W LeBlanc, Myles Nickolich, Christel N Rushing...

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Characteristics and outcomes of patients with advanced cancer evaluated by a palliative care team at an emergency center. A retrospective study.

Marvin Omar Delgado-Guay, Alfredo Rodriguez-Nunez, Seong Hoon Shin...

https://pubmed.ncbi.nlm.nih.gov/26590844