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Self Managed Care for Heart Disease
N/A
Recruiting
Led By Valluvan Jeevanandam, MD
Research Sponsored by University of Chicago
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 patient will be called weekly for 8 weeks by a medical professional.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare post-operative outcomes and quality of life for patients who manage their own sternal precautions following cardiac surgery, to those who receive standard care.
Who is the study for?
This trial is for English-speaking adults aged 18-70 who are undergoing a sternotomy, which is a type of heart surgery. They must be able to walk on their own. People with previous sternotomies, those getting VAD implants or cardiac transplants, or discharged over 1.5 weeks after surgery can't join.
What is being tested?
The study compares standard sternal precautions with self-managed care after heart surgery to see if the latter improves quality of life while maintaining similar pain levels and postoperative outcomes. Participants will be monitored up to one year through medical records and phone surveys.
What are the potential side effects?
Since this trial involves self-care procedures rather than medication, side effects may include discomfort or complications related to improper management of sternal precautions leading potentially to delayed healing or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patient will be called weekly for 8 weeks by a medical professional.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient will be called weekly for 8 weeks by a medical professional.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sternal Precaution Checklist
Secondary study objectives
Sternal Precaution Pain Scale
Sternal Precautions- Quality of Life Questions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Arm 1 will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge.
Group II: Arm 2Active Control1 Intervention
Arm 2 will receive the standard sternal precautions at time of post operative discharge.
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,072 Total Patients Enrolled
Valluvan Jeevanandam, MDPrincipal InvestigatorProfessor of Surgery
3 Previous Clinical Trials
68 Total Patients Enrolled