NCT05282654 Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions
| NCT ID | NCT05282654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Multiple Chronic Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,300 participants in total. It began in 2022-02-01 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.
Eligibility Criteria
Inclusion Criteria: * 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 * Have a discharge status of home, home with services, or facility * English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver) * Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver) * Two or more chronic conditions: Anxiety, Asthma\*, Arthritis (Osteoarthritis, Rheumatoid), Atrial Fibrillation, Cancer\*, Cerebral vascular accident, Chronic kidney disease\*, Chronic obstructive pulmonary disease (COPD)\*, Cirrhosis, Coronary artery disease/Ischemic heart disease, Dementia, Depression, Diabetes mellitus\*, End-stage renal disease\*, Heart failure\*, Hepatitis B, C\*, HIV/AIDs, Hyperlipidemia, Hypertension, Inflammatory bowel disease, Osteoporosis, Sickle cell disease, Substance abuse (Alcohol/Opioid) Exclusion Criteria: * Less than 18 years of age * Less than two chronic conditions * Hospitalized less than 24 hours * No identifiable healthcare proxy or next of kin (i.e., a family caregiver)
Contact & Investigator
Anuj Dalal, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05282654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Chronic Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05282654 currently recruiting?
Yes, NCT05282654 is actively recruiting participants. Contact the research team at adalal1@bwh.harvard.edu for enrollment information.
Where is the NCT05282654 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05282654 clinical trial?
NCT05282654 is sponsored by Brigham and Women's Hospital. The principal investigator is Anuj Dalal, MD at Brigham and Women's Hospital. The trial plans to enroll 1,300 participants.