Nctid:
NCT06615349
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"prospective, randomized, controlled"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>382}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-03", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"rate of unplanned rehospitalisations and emergency visits", "timeFrame"=>"84 days", "description"=>"measure will be derived from hospital reports as well as statements by the patient on a weekly basis"}], "secondaryOutcomes"=>[{"measure"=>"EORTC QLQ-C15-PAL", "timeFrame"=>"91 days", "description"=>"quality of life"}, {"measure"=>"SEC-P", "timeFrame"=>"91 days", "description"=>"sense of security"}, {"measure"=>"survival", "timeFrame"=>"365 days", "description"=>"overall survival"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Palliative Care", "chatbot", "wearable", "PROMs", "rehospitalisation", "mobile health"], "conditions"=>["Terminal Illness", "Terminal Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"17916873", "type"=>"BACKGROUND", "citation"=>"Wheatley VJ, Baker JI. \"Please, I want to go home\": ethical issues raised when considering choice of place of care in palliative care. 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Epub 2011 Jul 5."}, {"pmid"=>"32844592", "type"=>"BACKGROUND", "citation"=>"Ng A, Gupta E, Bansal S, Fontillas RC, Amos CE Jr, Williams JL, Dibaj S, Bruera E. Cancer Patients' Perception of Usefulness of Wearable Exercise Trackers. PM R. 2021 Aug;13(8):845-851. doi: 10.1002/pmrj.12475. Epub 2020 Oct 20."}, {"pmid"=>"31873052", "type"=>"BACKGROUND", "citation"=>"Pavic M, Klaas V, Theile G, Kraft J, Troster G, Blum D, Guckenberger M. Mobile Health Technologies for Continuous Monitoring of Cancer Patients in Palliative Care Aiming to Predict Health Status Deterioration: A Feasibility Study. J Palliat Med. 2020 May;23(5):678-685. doi: 10.1089/jpm.2019.0342. Epub 2019 Dec 23."}, {"pmid"=>"24705855", "type"=>"BACKGROUND", "citation"=>"Blum D, Koeberle D, Omlin A, Walker J, Von Moos R, Mingrone W, deWolf-Linder S, Hayoz S, Kaasa S, Strasser F, Ribi K. 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Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. doi: 10.1200/JCO.2016.68.4555. J Clin Oncol. 2019 Feb 20;37(6):528. doi: 10.1200/JCO.19.00057."}, {"pmid"=>"25803266", "type"=>"BACKGROUND", "citation"=>"Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015 Feb 24;17(2):e52. doi: 10.2196/jmir.3951."}, {"pmid"=>"22818070", "type"=>"BACKGROUND", "citation"=>"Bradley EH, Curry L, Horwitz LI, Sipsma H, Thompson JW, Elma M, Walsh MN, Krumholz HM. Contemporary evidence about hospital strategies for reducing 30-day readmissions: a national study. J Am Coll Cardiol. 2012 Aug 14;60(7):607-14. doi: 10.1016/j.jacc.2012.03.067. Epub 2012 Jul 18."}, {"pmid"=>"24677414", "type"=>"BACKGROUND", "citation"=>"Krevers B, Milberg A. The instrument 'sense of security in care--patients' evaluation': its development and presentation. Psychooncology. 2014 Aug;23(8):914-20. doi: 10.1002/pon.3502. Epub 2014 Feb 14."}, {"pmid"=>"22628898", "type"=>"BACKGROUND", "citation"=>"Wallace EM, Cooney MC, Walsh J, Conroy M, Twomey F. Why do palliative care patients present to the emergency department? Avoidable or unavoidable? Am J Hosp Palliat Care. 2013 May;30(3):253-6. doi: 10.1177/1049909112447285. Epub 2012 May 23."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nPatients 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.\n\nPalliative 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.\n\nAn 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.\n\nIn 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.\n\nThis 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.\n\nThis 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with established diagnosis of a metastatic cancer/severe illness with limited life expectancy receiving palliative care services\n* Estimated life expectancy \\<24 months (physician's guess)/ \\>3 months\n* Karnofsky Index ≥ 50% / ECOG≤ 2\n* Aged \\>18 years\n* Owns and uses a smartphone\n* Give written informed consent\n\nExclusion Criteria:\n\n* Patients under curative treatment\n* Relevant cognitive impairment"}, "identificationModule"=>{"nctId"=>"NCT06615349", "briefTitle"=>"DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Zurich"}, "officialTitle"=>"DigiPall; a Randomized Controlled Trial of Digital Patient Reported Outcome and Biomarker Monitoring in Palliative Care", "orgStudyIdInfo"=>{"id"=>"digiPall"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"DigiPall", "description"=>"Patients receive standard of care + DigiPall intervention", "interventionNames"=>["Behavioral: DigiPall"]}, {"type"=>"NO_INTERVENTION", "label"=>"control", "description"=>"Patients receive standard of care"}], "interventions"=>[{"name"=>"DigiPall", "type"=>"BEHAVIORAL", "description"=>"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.", "armGroupLabels"=>["DigiPall"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"8091", "city"=>"Zürich", "state"=>"ZH", "country"=>"Switzerland", "contacts"=>[{"name"=>"David Blum, MD PhD", "role"=>"CONTACT", "email"=>"david.blum@usz.ch", "phone"=>"0041442553742"}, {"name"=>"Manuel Amann, MS", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University Hospital Zurich", "geoPoint"=>{"lat"=>47.36667, "lon"=>8.54999}}], "centralContacts"=>[{"name"=>"David Blum, MD PhD", "role"=>"CONTACT", "email"=>"david.blum@usz.ch", "phone"=>"0041432533742"}], "overallOfficials"=>[{"name"=>"David Blum, MD PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Zurich"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"David Blum", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Zurich University of Applied Sciences", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"David Blum, MD PhD", "investigatorFullName"=>"David Blum", "investigatorAffiliation"=>"University of Zurich"}}}}
