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

July 7, 2025 updated by: David Blum

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

The aim of this study is to test if a system consisting of a wearable device measuring heartbeats and steps, together with daily communication with a chatbot on the smartphone asking the patients about their symptoms and giving tips, can reduce unplanned hospital readmissions and improve well-being in advanced cancer and severely ill patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to test the effect of a remote symptom and digital biomarker monitoring system on unplanned hospital readmissions, quality of life and sense of security in advanced cancer patients and patients with severe illnesses in palliative care.

Patients with cancer or other life-threatening illnesses are often burdened with pain and other distressing symptoms. Palliative care is an approach to prevent and relief suffering by means of early identification, assessment and treatment of these symptoms with the overall aim to improve quality of life of patients.

Palliative care wards are established in larger hospitals in Switzerland and provide short-term acute treatment of patients with incurable diseases. More than half of the patients are discharged home. However, unplanned rehospitalisations and emergency visits unfortunately occur frequently. Unplanned rehospitalisations are burdensome for the patient and caregiver and they are associated with higher costs. Up to 50% of unplanned rehospitalisations or hospital readmissions are deemed avoidable.

An unplanned hospital readmission within a specified time frame is an often applied quality benchmark in health care. When patients are discharged from specific palliative care wards, a good interprofessional outpatient or home care service has been most effective. However, close monitoring through home care teams is time consuming, costly, hindered by long distances and home care teams are not available everywhere. Furthermore, in many European countries primary care practices are rarified and reimbursement of home visits are insufficient. Therefore, new and innovative approaches for monitoring of this patient group are needed, especially in view of a growing number of patients and a decreasing number of care givers.

In the digital era self tracking is becoming more fashionable and daily screen-time is increasing. Concerning symptoms and well-being, patients monitoring themselves is the best option, because only they can adequately determine how they feel. Performance status and its deterioration can be remotely assessed by wearables. Mobile health technology is an easy and feasible way to monitor activity and health status.

This randomized controlled study aims to compare two groups of palliative patients, both receiving standard treatment with the intervention group additionally receiving the monitoring system. In the DigiPall intervention group, biomarker data is continuously gathered by a wearable device and questions about their subjective health status will be answered by the patients through chat. Based on their answers, automated feedback is provided. This feedback will not include any new prescriptions or suggest anything that was not already discussed with the treating physician, rather it will be reminding the patient of options in accordance to the existing treatment plan. There is strong evidence pointing to patients failing to implement the suggested treatment plan after discharge being a key factor in avoidable rehospitalisations. Therefore, the goal of the intervention is to strengthen the patient's self-management ability and sense of security, resulting in a better outcome in addition to reducing health care cost.

This approach has been well received in the feasibility study and the current study design has been developed with input by the patients themselves. During the study a patient group for advice will be consulted periodically.

Study Type

Interventional

Enrollment (Estimated)

382

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 Contact

Study Locations

  • Switzerland
    • ZH
      • Zürich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Manuel Amann, MS

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with established diagnosis of a metastatic cancer/severe illness with limited life expectancy receiving palliative care services
  • Estimated life expectancy <24 months (physician's guess)/ >3 months
  • Karnofsky Index ≥ 50% / ECOG≤ 2
  • Aged >18 years
  • Owns and uses a smartphone
  • Give written informed consent

Exclusion Criteria:

  • Patients under curative treatment
  • Relevant cognitive impairment

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DigiPall
Patients receive standard of care + DigiPall intervention
Behavioral: DigiPall
DigiPall is an intervention combining a sensor-equipped wearable with a chatbot communicating via WhatsApp on the patient's smartphone. Patients will be asked two questions daily for their subjective rating through WhatsApp on their smartphone, worded slightly differently depending on the measured values for steps, heart rate and compliance as well as the patient's answer the day before.
No Intervention: control
Patients receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of unplanned rehospitalisations and emergency visits
Time Frame: 84 days
measure will be derived from hospital reports as well as statements by the patient on a weekly basis
84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 365 days
overall survival
365 days
Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)
Time Frame: 91 days

14 items scored from 1-4, higher score indicates worse outcome

1 item scored from 1-7, higher score indicates better outcome
91 days
Sense of Security in Care - Patient Edition (SEC-P)
Time Frame: 91 days
16 items scored from 1-6, higher score indicates better outcome
91 days

Collaborators and Investigators

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

Sponsor

David Blum

Collaborators

Zurich University of Applied Sciences

Investigators

  • Principal Investigator: David Blum, MD PhD, University of Zurich

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)

June 11, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • digiPall

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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