Home-based Transitional Telerehabilitation in Cardiac Recovery

Coronary Artery Disease Clinical Trial

Official title:

Home-based Transitional Telerehabilitation in Cardiac Recovery: A Study on the Health-Related Quality of Life and Therapeutic Self-Care in Older Adults Post Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192290
• Other study ID #: Home-based TT in Cardiac Rec.
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2024
• Source: Mansoura University
• Contact: Ahmed H El-Monshed, Ph.D
• Phone: +97334046945
• Email: ahmed_elmonshed[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim is to determine the impact of home video-based cardiac rehabilitation program on elderly patients' health-related quality of life and therapeutic self-care post-coronary revascularization

Description:

Over the past decade, the efficacy of coronary artery bypass graft (CABG) surgery in treating coronary artery disease (CAD) has significantly advanced, particularly in improving symptom relief and survival rates among older adults. Remarkably, CAD stands as the foremost cause of global mortality, contributing to a staggering 16% of all deaths, with a notable surge of more than 2 million additional fatalities recorded in 2019, reaching a total of 8.9 million. This escalating incidence is particularly pronounced in the Middle East and North Africa, where CAD has witnessed a 160% increase, signifying a critical healthcare concern with a mortality rate of 120 per 100,000 individuals. In the realm of cardiovascular diseases, individuals aged 75 years and above face substantial threats, with CAD posing a significant threat to both morbidity and mortality. Despite the acknowledged benefits of CABG, older adults' post-CABG commonly grapple with a spectrum of musculoskeletal and neurological challenges stemming from the surgical procedure. This encompasses incisional sternotomy pain, respiratory issues, weakness, leg swelling, sleeping difficulties, wound healing complications, poor appetite, dissatisfaction with postoperative supportive care, and difficulties with eating. Psycho-socially, these individuals often experience distress, depression, a sense of loss of control, concerns about surgery success, social dysfunction, and fear of death. The postoperative period necessitates an in-hospital stay of approximately one week, with depressed functional capacity immediately following CABG, potentially linked to fear of activity and pain exacerbated by movement. This is followed by a convalescence period of 2 to 6 weeks for recovery after discharge and the resumption of daily activities. The healing process for chest and leg wounds typically spans 4 to 6 weeks, with pulmonary function and lung capacity decreasing one week following CABG up to 4-6 months after surgery compared to pre-surgery levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: February 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Aged 60 years or older
• diagnosed with CAD and were recommended to undergo elective CABG by a cardiologist
• intact cognitive function
• agree to be visited by the researchers at home
• didn't have previous experiences with CABG.

Exclusion Criteria:

• Have an experience with CABG
• demonstrates cognitive dysfunctions.

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Coronary Artery Disease

Intervention

Behavioral:
• Home-based transitional Cardiac Telerehabilitation
This comprehensive series is divided into 16 parts, each addressing crucial aspects of open-heart surgery recovery. Part 1 introduces open-heart surgery, heart disease symptoms, and preoperative preparations for elderly patients. Part 2 delves into cardiac rehabilitation, defining objectives and detailing recovery stages. Part 3 covers care for surgical incisions and infection signs. Part 4 explores sleep and rest, while Part 5 guides patients on a healthy post-surgery diet. Part 6 focuses on nursing interventions for dyspnea, and Part 7 addresses post-surgery cough. Part 8 discusses nursing interventions for thrombosis prevention

Locations

Country	Name	City	State
Egypt	Shark El-Madinah Hospital, the Secretariat of Specialized Medical Centers (Cardiothoracic Surgery Department and Intensive Care Unit)	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Fosbol EL, Zhao Y, Shahian DM, Grover FL, Edwards FH, Peterson ED. Repeat coronary revascularization after coronary artery bypass surgery in older adults: the Society of Thoracic Surgeons' national experience, 1991-2007. Circulation. 2013 Apr 23;127(16):1 — View Citation

Ghisi GL, Grace SL, Thomas S, Oh P. Behavior determinants among cardiac rehabilitation patients receiving educational interventions: an application of the health action process approach. Patient Educ Couns. 2015 May;98(5):612-21. doi: 10.1016/j.pec.2015.0 — View Citation

Lim SK, Han JY, Choe YR. Comparison of the Effects of Cardiac Rehabilitation Between Obese and Non-obese Patients After Acute Myocardial Infarction. Ann Rehabil Med. 2016 Oct;40(5):924-932. doi: 10.5535/arm.2016.40.5.924. Epub 2016 Oct 31. — View Citation

Osailan A, Abdelbasset WK. Exercise-based cardiac rehabilitation for postcoronary artery bypass grafting and its effect on hemodynamic responses and functional capacity evaluated using the Incremental Shuttle Walking Test: A retrospective pilot analysis. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary revascularization outcome questionnaire (CROQ)- CROQ-CABG version	Developed by schroter S and Lamping DL (2004) (34) to be the only practical and scientifically validated patient-based measure of outcome for coronary revascularization that is acceptable to patients, the only tool that includes psychosocial and cognitive functioning as well as surgery-specific items, and satisfies rigorous psychometric criteria for reliability, validity, and responsiveness. This validated instrument developed specifically for use before and after CABG and PTCA, which is quick and easy to administer and provides more appropriate content as it contains items directly addressing the impact of these procedures based on problems that patients reported to be important.	through study completion, an average of 1 year
Secondary	The Sidani Doran Therapeutic Self-Care Measure (SDTSCM) -The Home Setting care Version	Developed by Sidani and Doran (2001) & (2002) (35,36). to measure the action taken by a patient to promote, maintain or improve health, prevent sickness, detect and manage symptoms, and regain normal functioning. This 12-item scale measures a person's ability to perform activities that are directed at maintaining health, managing health, and restoring function (37). Patients were asked to rate their ability to perform self-care activities when home (38), with a 6-point numeric rating scale anchored with "not at all (0)" and "very much (5)".	through study completion, an average of 1 year