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

Not Applicable

Not yet recruiting

• Conditions: Terminal Illness; Terminal Cancer
• Interventions: Behavioral: DigiPall

• Registration Number: NCT06615349
• Lead Sponsor: David Blum

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Study Start: 2025-01-20
• Primary Completion: 2027-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 382

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DigiPall	DigiPall	Patients receive standard of care + DigiPall intervention

Primary Outcome Measures

Name	Time	Method
rate of unplanned rehospitalisations and emergency visits	84 days	measure will be derived from hospital reports as well as statements by the patient on a weekly basis

Secondary Outcome Measures

Name	Time	Method
Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL)	91 days	14 items scored from 1-4, higher score indicates worse outcome; 1 item scored from 1-7, higher score indicates better outcome
Sense of Security in Care - Patient Edition (SEC-P)	91 days	16 items scored from 1-6, higher score indicates better outcome
survival	365 days	overall survival

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, ZH, Switzerland