Clinical trial NCT06192290: Home-based Transitional Telerehabilitation in Cardiac Recovery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Cardiac Rehabilitation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 118
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coronary revascularization outcome questionnaire (CROQ)- CROQ-CABG version
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The Sidani Doran Therapeutic Self-Care Measure (SDTSCM) -The Home Setting care Version
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shark El-Madinah Hospital, the Secretariat of Specialized Medical Centers (Cardiothoracic Surgery Department and Intensive Care Unit)
Study officials:
References:
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.2015.01.006. Epub 2015 Jan 20.
citation: 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):1656-63. doi: 10.1161/CIRCULATIONAHA.113.001882. Epub 2013 Mar 26.
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. J Saudi Heart Assoc. 2020 Apr 17;32(1):25-33. doi: 10.37616/2212-5043.1005. eCollection 2020.
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.