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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines recovery after heart surgery, focusing on whether self-managed movement limits can improve quality of life while maintaining consistent pain levels and complications. One group will use self-managed precautions, allowing movement based on comfort, while the other group will adhere to standard post-surgery movement limits. The trial targets individuals who have undergone heart surgery through the sternum, can walk independently, and are discharged from the hospital within 1.5 weeks. As an unphased trial, it offers participants the chance to contribute to innovative recovery strategies that could enhance post-surgery quality of life.

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 prior data suggests that self-managed sternal precautions are safe for postoperative care?

Research has shown that starting recovery exercises two weeks after chest surgery is as safe as beginning them six weeks later. Patients can safely manage their activity levels by monitoring their pain and discomfort. Another study examined chest protection methods post-surgery and found they did not increase pain or reduce quality of life, indicating these methods are safe. Although specific data on self-managed care is lacking, these findings suggest it is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores self-managed care for heart disease patients, offering a potentially more flexible approach to post-operative recovery. Unlike standard care, which often involves strict adherence to sternal precautions, this method allows patients to use pain and discomfort as guides for physical activity. This could empower patients to take an active role in their recovery, potentially leading to improved comfort and faster rehabilitation. By focusing on patient autonomy, researchers hope to find out if this approach can safely enhance recovery outcomes compared to traditional methods.

What evidence suggests that self-managed sternal precautions are effective for heart disease recovery?

This trial will compare two approaches to post-operative care for heart surgery patients. Participants in Arm 1 will use pain and discomfort as the safe limits for upper limb use during daily activities at post-operative discharge. Participants in Arm 2 will follow standard sternal precautions at the time of post-operative discharge. Research has shown that taking charge of one's own care after heart surgery can be as effective, or even more so, than traditional recovery methods. One study found that starting heart rehab exercises two weeks after surgery worked as well and was likely as safe as starting six weeks later. Another study discovered that fewer restrictions after surgery improved physical abilities, reduced pain, and boosted quality of life. Adjusting chest protection after surgery also led to better health outcomes. These findings suggest that managing one's own recovery can be both beneficial and safe. ^{1 2 3 5 6}

Who Is on the Research Team?

Valluvan Jeevanandam, MD

Principal Investigator

Professor of Surgery

Are You a Good Fit for This Trial?

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

English speaking

I am scheduled for or have had a sternotomy.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0147956324001894

Evaluation of the quality and self-management related ... Evaluation of the quality and self-management related content of websites promoting physical activity engagement after myocardial infarction or cardiac surgery: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9218928/

Effectiveness and Safety of Early Initiation ... Starting cardiac rehabilitation exercise training 2 weeks after sternotomy was as effective, and likely as safe, as starting 6 weeks after sternotomy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5481951/

The Sternal Management Accelerated Recovery Trial ... The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life ...

4. researchgate.net researchgate.net/publication/385390388_Replacing_Sternal_Precautions_as_Part_of_a_Cardiac_Enhanced_Recovery_Program

(PDF) Replacing Sternal Precautions as Part of a Cardiac ... Methods Data from 1640 consecutive adult cardiac surgery patients with a median sternotomy from October 2020 to December 2023 were analyzed.

5. journals.lww.com journals.lww.com/mjdy/fulltext/2022/15060/the_impact_of_a_less_restrictive_post_sternotomy.2.aspx

The impact of a less restrictive post-sternotomy activity... Can reducing SRs for cardiac surgery patients via median sternotomy improve physical function, pain, kinesiophobia, and health-related quality of life? Data ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/03080226231212984

Occupational therapy and participation in activities of daily ... This retrospective study of electronic medical records examined changes in activities of daily living participation for adult patients (n = 37) who received ...