Home-based Transitional Telerehabilitation in Cardiac Recovery

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Cardiac Rehabilitation
• Interventions: Behavioral: Home-based transitional Cardiac Telerehabilitation

• Registration Number: NCT06192290
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2021-12-31
• Primary Completion: 2023-09-01
• Study First Submitted: 2023-12-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Home-based transitional Cardiac Telerehabilitation	(1) aged 60 years or older; (2) diagnosed with CAD and were recommended to undergo elective CABG by a cardiologist; (3) intact cognitive function; (4) agree to be visited by the researchers at home; and (5) didn't have previous experiences with CABG. These Patients will receive the Video film presentations and content (16 parts)

Primary Outcome Measures

Name	Time	Method
Coronary revascularization outcome questionnaire (CROQ)- CROQ-CABG version	through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
The Sidani Doran Therapeutic Self-Care Measure (SDTSCM) -The Home Setting care Version	through study completion, an average of 1 year	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)".

Trial Locations

Locations (1)

Shark El-Madinah Hospital, the Secretariat of Specialized Medical Centers (Cardiothoracic Surgery Department and Intensive Care Unit); 🇪🇬 Alexandria, Egypt