Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615349
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
DigiPall a Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DigiPall a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None