An interventional study of Supplemental Text Messaging and Education and Training for Patient-Generated Data in Sepsis, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
The purpose of this study is to find out if patients that receive supportive messaging with response adaptation are more likely to adhere to patient-generated data collection and electronic health record integration, compared to patients that do not receive supportive messaging.
This project will directly inform re-usable strategies to support the integration of important patient-generated data (PGD) into the electronic health record to improve clinical care and research. For this application, investigators propose to develop and test the PGD translational science innovation in patients recovering from sepsis. This diverse patient population frequently suffers from long-term complications that are ideally suited for development and demonstration of strategies to collect, integrate, and examine PGD and builds directly on the study team's robust research portfolio on improving sepsis recovery.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
Browse Sepsis studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supportive messaging is a behavioral intervention delivered to motivate patients to engage with targeted patient-generated data collection tools. Participants will be asked to complete patient-generated data. At baseline, all patients will receive education about the collection of patient-generated data, training in using the data collection tools, and guidance on the standard frequency for collection and sharing of information. At baseline and regular intervals throughout follow up, the supportive messaging arm will receive added text messaging to engage patients and deliver personalized reminders to complete monitoring tasks.
Behavioral: Supplemental Text Messaging
Participants will be asked to complete patient-generated data. At baseline, participants will receive education about the collection of patient-generated data, training in using the data collection tools, and guidance on the standard frequency for collection and sharing of information. Participants will not receive added text messaging to engage patients and deliver personalized reminders to complete monitoring tasks.
Behavioral: Education and Training for Patient-Generated Data
Will receive education about the collection of patient-generated data, training in using the data collection tools, and guidance on the standard frequency for collection and sharing of information. Supplemental text messages will be sent to engage patients and deliver personalized reminders to complete monitoring tasks.
Will receive education about the collection of patient-generated data, training in using the data collection tools, and guidance on the standard frequency for collection and sharing of information.
Proportion of Completed Versus Requested Patient-Generated Data
Patient generated data completion defined as the proportion of completed vs requested patient generated data elements.
Time frame: 90 days post hospital discharge
Number of Readmissions
Number of readmissions to inpatient or observation status due to any cause assessed via electronic health record.
Time frame: 90 days post hospital discharge
Number of Deaths
Number of participant deaths due to any cause, assessed via electronic health record and national data sources integrated in the enterprise data warehouse.
Time frame: 90 days post hospital discharge
Number of Emergency Department Visits
Number of Emergency Department visits assessed via electronic health record.
Time frame: 90 days post hospital discharge
Number of Outpatient Clinic Visits
Number of outpatient clinic visits assessed via electronic health record
Time frame: 90 days post hospital discharge
Number of Hospital-Free Days
Number of hospital-free days calculated by total of days alive minus days hospitalized, measured from electronic health record data.
Time frame: 90 days post hospital discharge
No study locations are listed for this record.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification will be shared (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences