Self Managed Care for Heart Disease
Recruiting in Palo Alto (17 mi)
Overseen byValluvan Jeevanandam, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Disqualifiers: VAD implantation, Cardiac transplantation, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. The purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. Postoperative pain and postoperative quality of lives will be assessed by phone call surveys. Postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Self Managed Care for Heart Disease?
Research suggests that self-management can improve disease outcomes and quality of life for patients with cardiovascular disease, indicating that self-managed care may be beneficial for heart disease patients.
12345Is Self Managed Care for Heart Disease safe for humans?
The research articles reviewed do not provide specific safety data for Self Managed Care for Heart Disease or its related terms. They focus on educational resources, self-care behaviors, and self-help groups for heart disease patients, but do not address safety concerns directly.
12467How does the self-managed care treatment for heart disease differ from other treatments?
The self-managed care treatment for heart disease is unique because it empowers patients to actively participate in their own care, focusing on self-management strategies rather than relying solely on healthcare providers. This approach is designed to improve well-being and manage symptoms by fostering patient engagement and utilizing new modes of delivery for greater access to information.
4891011Eligibility Criteria
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.Inclusion Criteria
I am scheduled for or have had a sternotomy.
I am between 18 and 70 years old.
English speaking
+1 more
Exclusion Criteria
I had open-heart surgery for a device implant or heart transplant.
I have had surgery that opened my chest before.
I was discharged more than 1.5 weeks after my surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized into two groups to receive either self-managed or standard sternal precautions post-surgery
8 weeks
Weekly phone calls
Follow-up
Participants are monitored for postoperative outcomes, pain, and quality of life for up to a year
Up to 12 months
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
An exploration of the relationship between coronary artery bypass graft patients' self-sought educational resources and outcomes. [2019]Postoperative coronary artery bypass graft (CABG) patients seek educational resources around discharge. There is limited research on the type and perceived effectiveness of self-sought educational resources. The purpose of this study was to describe the use of self-sought educational resources by patients around time of discharge and to explore relationships between use of self-sought educational resources and self-care knowledge, performance of self-care behavior, and symptom frequency. This study is a substudy of a randomized clinical trial that included a convenience sample of first-time CABG patients. Significant correlations were found between use of self-sought educational resources and greater frequency of patient's behavior (P
Relationship between patient group participation and self-care agency among patients with a history of cardiac surgery: A cross-sectional study. [2018]Little is known regarding the influence of participation in patient groups on self-care in patients with a cardiac surgery history.
Perceived social support and self-care in patients hospitalized with heart failure. [2022]Rehospitalization of heart failure patients is often considered the result of inadequate self-care yet only one study documents superior outcomes with better self-care.
Self-help groups for patients with coronary heart disease as a resource for rehabilitation and secondary prevention-what is the evidence? [2009]Cardiovascular heart disease (CHD) is a major health care concern worldwide. Maintaining regular cardiac rehabilitation attendance and secondary-prevention strategies are significant health care challenges. Although self-help groups provide benefit for many chronic health conditions, it is not clear if they address the challenges of CHD rehabilitation and self-management. This literature review was guided by the following question: Can self-help groups address the challenges of CHD rehabilitation and self-management? This article reviews the traditional published and "grey" literature on CHD-related self-help groups identified from a database search (Cochrane Library, PubMed, PsychINFO, Medline, Cumulative Index to Nursing and Allied Health Literature, Applied Social Sciences Index and Abstracts, and Social Sciences Citation Index). Identified articles were screened based on the type of initiative: Community-based non-health service-organized groups were included, but hospital-based group treatment and therapy interventions or programs were excluded. Published research and analysis of CHD-related self-help groups is scarce. Sixteen articles focusing on self-help groups were identified. The review results indicate that the limited quantity, limited range, and variable quality of studies prevents reliable conclusions being made regarding effects and outcomes as well as the extent and profile of participation. Strengthening the evidence base regarding the impact of CHD-related self-help groups, the reasons for participation versus nonparticipation in such groups, and determining nonparticipants support needs must be done to establish if and for which patients such groups constitute an effective resource for rehabilitation and secondary prevention.
The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation. [2022]Self-management can increase self-efficacy and quality of life and improve disease outcomes. Effective self-management may also help reduce the pressure on health care systems. However, patients need support in dealing with their disease and in developing skills to manage the consequences and changes associated with their condition. Web-based self-management support programs have helped patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA), but program use has been low.
An examination of the difference in performance of self-care behaviours between white and non-white patients following CABG surgery: a secondary analysis. [2022]The demographic profile of the patient receiving coronary artery bypass graft (CABG) surgery in Canada has changed significantly over the past 20 years from mainly white (i.e., English, Irish, Scottish) to non-white (i.e., Indian or Chinese). To support individuals who have recently undergone a CABG procedure, patient education is provided to guide performance of self-care behaviours in the home environment. The relevance of this education, when applied to the current CABG surgery population, is questionable, as it was designed and tested using a white, homogenous sample. Thus, the number and type of self-care behaviours performed by persons of Indian and Chinese origin has not been investigated. These individuals may have varying self-care needs that are not reflected in the current self-care patient education materials.
A qualitative study exploring why people do not participate in cardiac rehabilitation and coronary heart disease self-help groups, and their rehabilitation experience without these resources. [2018]Secondary prevention and self-management of coronary heart disease (CHD) are of major importance to people who survive myocardial infarction (MI). This can be facilitated by cardiac rehabilitation (CR; the formal health service programme) and informal CHD self-help groups. Non-participation is an important issue, yet it is poorly understood. Rehabilitation difficulties and prevention challenges have been identified among people following MI, but the particular experience and perspective of CR and CHD group non-participants are largely unknown.
Self-management of coronary heart disease in older patients after elective percutaneous transluminal coronary angioplasty. [2020]To explore how older patients self-manage their coronary heart disease (CHD) after undergoing elective percutaneous transluminal coronary angioplasty (PTCA).
Self-management of rheumatic diseases: state of the art and future perspectives. [2022]Self-management interventions are patient-centred and designed to foster active participation of patients in order to promote well-being and to manage symptoms. Over the past two decades, the role of self-management in chronic diseases has gained momentum. Self-management programmes are now acknowledged as a key element of quality care. New modes of delivery allow greater access to information and are tailored to address patient needs. This systematic review presents data from clinical studies of self-management over the past decade, summarises the evidence for programme effectiveness, and suggests future research directions.
Ethically problematic assumptions regarding patient self management and barriers to improved outcomes. [2010]Patient self management of chronic conditions, both the disease and the symptoms, is an aged practice that is accelerating and disseminating throughout the world, fueled in part by home-based and portable technologies. Ethically problematic assumptions, continued from a provider-dominated era, have the potential to harm some patients and unnecessarily exclude others from self management. This special report will describe three such problematic assumptions, suggest ethically satisfactory alternatives and describe the barriers to making these transitions. Improved assumptions suggest that patient self management has the potential to set a new and higher standard than the current provider-based practice; that readiness to learn, literacy and intact cognitive function are frequently not essential to competent patient self management; that patients, however, are still excluded from it based on apparent defects in these characteristics; and that quality control standards for self management are essential but are not sufficiently rigorous. Barriers to improved outcomes from self management include the virtual absence of objective measures of patient competence to self manage, and of explicit, publicly available and well-argued descriptions of risk and benefit.
'Getting your life back on track after stroke': a Phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors. [2022]Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.