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Patient-Centered Medical Home (PCMH) for Blood Disorders
N/A
Waitlist Available
Led By Nelson J C, MD, MBA
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether it's safe to let people who have had a stem cell transplant for cancer go home sooner after the transplant instead of staying in the hospital.
Eligible Conditions
- Blood Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Graft Versus Host Disease (aGVHD)
Secondary outcome measures
Disease Free Survival (DFS)
Overall Survival
Rate of Infection
Other outcome measures
Comparison of Gut Microbiota
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient-Centered Medical Home (PCMH)Experimental Treatment1 Intervention
Day-to-Day Care:
Advanced Practice Providers (APP) will travel to subjects' homes in the morning, where they will perform the same daily assessment as standard care. They will draw labs and bring them back to the hospital for processing. When results are available, a second home visit is made to deliver necessary interventions. Subjects will have internet access through cellular-networked iPads and have daily videoconferences with their physicians. Daily follow up at home will continue until discharge as per above criteria.
Caregivers: identified by the subject as the person taking primary care of them will answer surveys and also collect stool samples to analyze in conjunction with those from subjects.
Group II: Standard CareActive Control1 Intervention
These subjects will begin as inpatients or outpatients, where advanced practice providers (APPs) (nurse practitioners and physician assistants) will perform histories and physical exams. Nurses will collect labs and providers will enter orders in our electronic health record (EHR). All steps will be repeated daily until discharge to home. Suitability for discharge is determined by standard clinical criteria including stable blood counts, freedom from active or severe complications (e.g. active infection, severe GVHD), and ability to care for self.
Caregivers: identified by the subject as the person taking primary care of them will answer surveys and also collect stool samples to analyze in conjunction with those from subjects.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,161 Total Patients Enrolled
Nelson J C, MD, MBAPrincipal InvestigatorDuke University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost headcount of participants engaging in this clinical trial?
"Indeed, the information on clinicaltrials.gov reveals that this research endeavour is actively seeking participants to join in their efforts. It was first published on October 1st 2014 and has since been updated as of October 6th 2022 with a need for 180 patients across one site."
Answered by AI
Is this trial still open to new participants?
"Affirmative. According to information published on clinicaltrials.gov, this medical trial is actively enrolling patients and was last updated October 6th 2022. The study seeks 180 volunteers at a single site of enrollment."
Answered by AI
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