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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• rate of unplanned rehospitalisations and emergency visits [Срок оценки: 84 days]

Вторичные конечные точки (3)

• Quality of Life in palliative cancer care patients (EORTC QLQ-C15-PAL) [Срок оценки: 91 days]
• Sense of Security in Care - Patient Edition (SEC-P) [Срок оценки: 91 days]
• survival [Срок оценки: 365 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Patients under curative treatment
• Relevant cognitive impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• University Hospital Zurich — Zurich

Публикации

• Wheatley VJ, Baker JI. "Please, I want to go home": ethical issues raised when considering choice of place of care in palliative care. Postgrad Med J. 2007 Oct;83(984):643-8. doi: 10.1136/pgmj.2007.058487. PMID 17916873
• Alsirafy SA, Raheem AA, Al-Zahrani AS, Mohammed AA, Sherisher MA, El-Kashif AT, Ghanem HM. Emergency Department Visits at the End of Life of Patients With Terminal Cancer: Pattern, Causes, and Avoidability. Am J Hosp Palliat Care. 2016 Aug;33(7):658-62. doi: 10.1177/1049909115581819. Epub 2015 Apr 15. PMID 25877944
• Donze JD, Lipsitz S, Schnipper JL. Risk Factors and Patterns of Potentially Avoidable Readmission in Patients With Cancer. J Oncol Pract. 2017 Jan;13(1):e68-e76. doi: 10.1200/JOP.2016.011445. Epub 2016 Oct 23. PMID 28084884
• Gerhardt G, Yemane A, Hickman P, Oelschlaeger A, Rollins E, Brennan N. Medicare readmission rates showed meaningful decline in 2012. Medicare Medicaid Res Rev. 2013 May 28;3(2):mmrr.003.02.b01. doi: 10.5600/mmrr.003.02.b01. eCollection 2013. PMID 24753966
• Chang VT, Hwang SS, Feuerman M, Kasimis BS. Symptom and quality of life survey of medical oncology patients at a veterans affairs medical center: a role for symptom assessment. Cancer. 2000 Mar 1;88(5):1175-83. doi: 10.1002/(sici)1097-0142(20000301)88:53.0.co;2-n. PMID 10699909
• Peters L, Sellick K. Quality of life of cancer patients receiving inpatient and home-based palliative care. J Adv Nurs. 2006 Mar;53(5):524-33. doi: 10.1111/j.1365-2648.2006.03754.x. PMID 16499673
• LeBlanc TW, Nickolich M, Rushing CN, Samsa GP, Locke SC, Abernethy AP. What bothers lung cancer patients the most? A prospective, longitudinal electronic patient-reported outcomes study in advanced non-small cell lung cancer. Support Care Cancer. 2015 Dec;23(12):3455-63. doi: 10.1007/s00520-015-2699-4. Epub 2015 Mar 21. PMID 25791391
• Delgado-Guay MO, Rodriguez-Nunez A, Shin SH, Chisholm G, Williams J, Frisbee-Hume S, Bruera E. Characteristics and outcomes of patients with advanced cancer evaluated by a palliative care team at an emergency center. A retrospective study. Support Care Cancer. 2016 May;24(5):2287-2295. doi: 10.1007/s00520-015-3034-9. Epub 2015 Nov 21. PMID 26590844

Идентификаторы

NCT: NCT06615349 · digiPall

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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