Self Managed Care for Heart Disease

Overseen By Leila Yazdanbakhsh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: VAD implantation, Cardiac transplantation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

64 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 4 6 7}

How 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. ^{4 8 9 10 11}

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.

Research Team

Valluvan Jeevanandam, MD

Principal Investigator

Professor of Surgery

Eligibility 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.

English speaking

I can walk on my own without help.

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.

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

Treatment Details

Interventions

• Self Managed Care

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 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 2 Active Control 1 Intervention

Arm 2 will receive the standard sternal precautions at time of post operative discharge.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Patients who underwent coronary artery bypass graft (CABG) surgery actively sought educational resources around discharge, which correlated with improved self-care behaviors and reduced symptom frequency.

This study highlights the potential benefits of self-sought educational resources in enhancing patient outcomes post-CABG, suggesting that providing such resources may be an important aspect of patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of the relationship between coronary artery bypass graft patients' self-sought educational resources and outcomes. Fredericks, S., Sidani, S.[2019]

Participation in patient groups is linked to improved self-care among patients with a history of cardiac surgery, as indicated by a study of 566 respondents, primarily male with an average age of 70.6 years.

Higher levels of social support from these groups positively influenced various aspects of self-care agency, including self-care operations and attention to self-care, suggesting that social engagement can enhance health management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between patient group participation and self-care agency among patients with a history of cardiac surgery: A cross-sectional study. Noguchi-Watanabe, M., Yamamoto-Mitani, N., Arimoto, A., et al.[2018]

Hospitalized heart failure patients demonstrated significantly lower self-care skills and perceived social support compared to non-hospitalized patients, suggesting a link between inadequate self-care and rehospitalization.

The study found that self-care confidence was positively related to perceived social support, indicating that improving social support may enhance self-care abilities in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived social support and self-care in patients hospitalized with heart failure. Chamberlain, L.[2022]

The literature review identified only 16 articles on self-help groups for cardiovascular heart disease (CHD), indicating a significant lack of research on their effectiveness in rehabilitation and self-management.

Current studies on CHD-related self-help groups are limited in quantity and quality, making it difficult to draw reliable conclusions about their impact and the reasons for patient participation or nonparticipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-help groups for patients with coronary heart disease as a resource for rehabilitation and secondary prevention-what is the evidence? Jackson, AM., Gregory, S., McKinstry, B.[2009]

Younger patients and those with lower education levels were more likely to use web-based self-management support programs for cardiovascular disease (CVD) and rheumatoid arthritis (RA), indicating that demographic factors influence program engagement.

The design of the program and specific behavior change techniques, such as tailored information and reminders, significantly encouraged program use, highlighting the importance of user-friendly features and professional recommendations in increasing participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation. Engelen, M., van Gaal, B., Vermeulen, H., et al.[2022]

A study involving 99 patients from three cultural groups (White, Indian, and Chinese) found significant differences in self-care behaviors after coronary artery bypass graft (CABG) surgery, particularly in the use of incentive spirometers and deep breathing exercises.

Non-white patients demonstrated different self-care needs compared to white patients, highlighting the importance of culturally relevant patient education materials for post-surgery care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of the difference in performance of self-care behaviours between white and non-white patients following CABG surgery: a secondary analysis. Fredericks, S., Lo, J., Ibrahim, S., et al.[2022]

A study involving in-depth interviews with 27 individuals who did not participate in cardiac rehabilitation (CR) or coronary heart disease (CHD) self-help groups revealed that many viewed non-participation as a 'missed opportunity' for recovery, highlighting unmet needs in their rehabilitation process.

The reasons for non-participation were categorized into three themes: feeling there was 'no need', perceiving it as 'not worth it', and believing it was 'not possible', indicating that addressing these perceptions could improve participation rates and support for individuals recovering from myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jackson, AM., McKinstry, B., Gregory, S., et al.[2018]

A study of 93 patients, including 47 older adults (65+ years), revealed that many older patients (78.7%) manage recurring angina symptoms by taking glyceryl trinitrate, but a significant portion (40.5%) would call for emergency help regardless of symptom severity, indicating a lack of confidence in self-management.

Older participants had fewer coronary heart disease risk factors, such as lower weight and smoking rates, but their age did not influence their willingness to change dietary habits, suggesting that while they may be healthier, they may not be as informed about managing their condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of coronary heart disease in older patients after elective percutaneous transluminal coronary angioplasty. Dawkes, S., Smith, GD., Elliott, L., et al.[2020]

Self-management interventions empower patients to actively participate in their care, which has become increasingly recognized as essential for managing chronic diseases and improving overall well-being.

The systematic review highlights that self-management programs have shown effectiveness in clinical studies over the past decade, indicating their importance in quality care and suggesting the need for further research to enhance these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of rheumatic diseases: state of the art and future perspectives. Iversen, MD., Hammond, A., Betteridge, N.[2022]

Patient self-management of chronic conditions is becoming more widespread due to advancements in home-based technologies, but there are ethical concerns about excluding patients based on outdated assumptions about their abilities.

Improved assumptions about self-management suggest that it can exceed traditional provider-based practices, yet barriers remain, such as a lack of objective measures for patient competence and insufficient quality control standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethically problematic assumptions regarding patient self management and barriers to improved outcomes. Redman, BK.[2010]

This Phase II randomized-controlled trial aims to evaluate the safety and feasibility of a stroke-specific self-management program for stroke survivors, involving various recruitment sources across Adelaide, South Australia.

Participants will be assessed for feasibility and safety, with outcomes including quality of life, mood improvements, and health resource utilization, to determine if a larger Phase III efficacy trial is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'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. Battersby, M., Hoffmann, S., Cadilhac, D., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

An exploration of the relationship between coronary artery bypass graft patients' self-sought educational resources and outcomes. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Relationship between patient group participation and self-care agency among patients with a history of cardiac surgery: A cross-sectional study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Perceived social support and self-care in patients hospitalized with heart failure. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Self-help groups for patients with coronary heart disease as a resource for rehabilitation and secondary prevention-what is the evidence? [2009]

5. Canada pubmed.ncbi.nlm.nih.gov

The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

An examination of the difference in performance of self-care behaviours between white and non-white patients following CABG surgery: a secondary analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. China pubmed.ncbi.nlm.nih.gov

Self-management of coronary heart disease in older patients after elective percutaneous transluminal coronary angioplasty. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Self-management of rheumatic diseases: state of the art and future perspectives. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Ethically problematic assumptions regarding patient self management and barriers to improved outcomes. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

'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]