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

ConditionsTerminal IllnessTerminal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Blum

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients under curative treatment

Relevant cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • DigiPall

    Behavioral

    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.

Treatment groups

382 Participants
are divided into 2 treatment groups
Group A: DigiPallExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

rate of unplanned rehospitalisations and emergency visits

measure will be derived from hospital reports as well as statements by the patient on a weekly basis

Time frame
84 days

Secondary outcomes

1

Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)

14 items scored from 1-4, higher score indicates worse outcome 1 item scored from 1-7, higher score indicates better outcome

Time frame
91 days
2

Sense of Security in Care - Patient Edition (SEC-P)

16 items scored from 1-6, higher score indicates better outcome

Time frame
91 days
3

survival

overall survival

Time frame
365 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Blum

Lead sponsor

University of Zurich

Sponsor institution

Zurich University of Applied Sciences

Collaborator

Source ClinicalTrials.gov
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