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ePRO Monitoring for Chronic Disease Care Transitions

N/A

Recruiting

Led By Anuj Dalal, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (18 years or older)

Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30-days after discharge from index hospitalization

Awards & highlights

Study Summary

This trial aims to develop a system to identify and predict patient symptoms after discharge in order to minimize adverse events. The system will use patient-reported symptoms and predictive algorithms to escalate to inpatient and ambulatory clinicians. The study will be conducted with patients who have multiple chronic conditions and will be evaluated for its impact on post-discharge adverse events.

Who is the study for?

This trial is for adults with two or more chronic conditions like heart disease, diabetes, COPD, etc., who are hospitalized and will be discharged to home or a facility. They must speak English or have an English-speaking healthcare proxy.Check my eligibility

What is being tested?

The study tests an ePRO application designed to monitor symptoms in real-time and predict adverse events after patients with multiple chronic conditions leave the hospital. It involves developing predictive models and integrating them into digital health apps.See study design

What are the potential side effects?

Since this trial involves using a symptom monitoring app rather than medication, traditional side effects are not expected. However, there may be technical issues or stress related to using the technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been in the hospital for at least a day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30-days after discharge from index hospitalization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30-days after discharge from index hospitalization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30-days after discharge from index hospitalization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Actual adverse events (AEs)

Actual preventable adverse events (AEs)

Secondary outcome measures

Post-discharge healthcare utilization (ambulatory events)

Post-discharge healthcare utilization events (hospital readmissions)

Potential adverse events (AEs)

Other outcome measures

Time to actual AE

Time to potential AE

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (Arm 3)Experimental Treatment1 Intervention

During the 30-month Main Trial (RCT) Period, patients will be randomized to the intervention (Arm 3, n=425). Data collection for post-discharge AE determination will occur during both periods.

Group II: Usual Care (Arm 1)Active Control1 Intervention

During the 18-month Baseline Period (Arm 1, n=450) patients will be enrolled and receive usual care to develop the initial predictive model.

Group III: Usual Care (Arm 2)Active Control1 Intervention

During the 30-month Main Trial (RCT) Period, patients will be randomized to usual care (Arm 2, n=425). Data collection for post-discharge AE determination will occur during both periods.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,469,027 Total Patients Enrolled

3 Trials studying Adverse Events

2,697 Patients Enrolled for Adverse Events

RANDOTHER

137 Previous Clinical Trials

508,951 Total Patients Enrolled

Anuj Dalal, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

ePRO Application Clinical Trial Eligibility Overview. Trial Name: NCT05282654 — N/A

Adverse Events Research Study Groups: Usual Care (Arm 1), Usual Care (Arm 2), Intervention (Arm 3)

Adverse Events Clinical Trial 2023: ePRO Application Highlights & Side Effects. Trial Name: NCT05282654 — N/A

ePRO Application 2023 Treatment Timeline for Medical Study. Trial Name: NCT05282654 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this clinical trial?

"According to information listed on clinicaltrials.gov, this medical research is currently recruiting patients and has been since February 1st 2022. The trial underwent a final update on March 7th 2022."

Answered by AI

Could you apprise me of the upper limit in regards to how many volunteers are taking part in this experiment?

"Affirmative. The clinicaltrials.gov website reveals that this medical trial, first publicized on February 1st 2022, is still in search of participants. 1300 individuals are required to be recruited from 2 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions

Anuj K. Dalal, MD 2022. "Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05282654.