An interventional study of DigiPall in Terminal Illness and Terminal Cancer, sponsored by David Blum. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by David Blum · Not applicable, Interventional, and Supportive 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.
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.
David Blum is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard of care + DigiPall intervention
Behavioral: DigiPall
Patients receive standard of care
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.
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
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
Sense of Security in Care - Patient Edition (SEC-P)
16 items scored from 1-6, higher score indicates better outcome
Time frame: 91 days
survival
overall survival
Time frame: 365 days
Plan to share: No
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David Blum