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Self Managed Care for Heart Valve 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
Undergoing a sternotomy
Aged between 18-70 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient will be called weekly for 8 weeks by a medical professional.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for or have had a sternotomy.
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I am between 18 and 70 years old.
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I can walk on my own without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient will be called weekly for 8 weeks by a medical professional.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient will be called weekly for 8 weeks by a medical professional. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sternal Precaution Checklist
Secondary outcome measures
Sternal Precaution Pain Scale
Sternal Precautions- Quality of Life Questions

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
997 Previous Clinical Trials
817,634 Total Patients Enrolled
Valluvan Jeevanandam, MDPrincipal InvestigatorProfessor of Surgery
3 Previous Clinical Trials
68 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available openings to participate in this investigation?

"Clinicaltrials.gov suggests that this medical trial is not actively searching for participants, as the posting went live on June 1st 2022 and was last updated in April of 20222. Nevertheless, there are currently 1256 studies looking to acquire patients."

Answered by AI

Is participation in this research open to the public?

"This clinical trial is seeking 64 individuals, aged 18-70 years old with heart failure. Additional criteria include: recent sternotomy surgery, the ability to comprehend English language and walk independently."

Answered by AI

Is the age of 65 a barrier to enrollment in this research?

"The study is open to those aged 18 or above and below 70 years old."

Answered by AI
~19 spots leftby Jan 2025