Effect of Cardiac Rehabilitation on Health Status, Emotional Outcomes, and 90-day Readmission Rate Among Cardiac Surgery Patients

Effect of Phase II Comprehensive Cardiac Rehabilitation Program on Perceived Health Status and 90-Day Readmission Rate, Anxiety, and Depression Among Coronary Artery Bypass Graft Patients in Jordan

this study aims to investigate the effect of the cardiac rehabilitation program on perceived health, status, anxiety, depression, and 90-day readmission rates for post-cardiac surgery patients. The participants in this study will be randomly allocated to either an experimental or control group, the experimental group will receive the cardiac rehabilitation programThe cardiac rehabilitation program extends over 3 months after cardiac surgery. The program includes exercise, health education, and stress management. All content will delivered to the participants through the WhatsApp application as instruction videos and short lectures. exercise will be gradually increased in terms of intensity, and duration. Health education will cover topics like a healthy diet blood pressure, blood cholesterol control, smoking cessation..etc. Stress management will include relaxation therapy, breathing control, behavioral change, and other strategies to control stress. All interventions are guided by universal guidelines like the Australian Cardiovascular Health and Rehabilitation Association (ACRA) and American Heart Association (AHA)..All potential participants will be assessed before being involved in the study. assessment including a general physical examination, inspection of the surgical site, and recent history for potential patient symptoms after discharge, such as chest pain, palpitation, fatigue, or dyspnea. The assessment includes electrocardiograph (ECG), blood samples, and echocardiography analyses. Based on the findings of this assessment, patients will be classified by the cardiologist as either grade I, II, III, or IV, according to the New York Heart Association (NYHA) Classification. Patients who will be eligible to participate in the present study should be grade I or II in the NYHA Classification for dyspnea. Participants in the control group will receive the usual care (general instructions and advice from physicians and nurses). All materials will be delivered to all participants after completing the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Status, Anxiety, Depression, and 90-day Readmission
• Intervention / Treatment: Behavioral: Phase II comprehensive cardiac rehabilitation program

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ALI SU HARBI; Phone Number: +962790070415; Email: capalialharbi@yahoo.com
• Study Contact Backup: Name: Mohammed NA Alnajdawi; Phone Number: 0096279119429; Email: raiq2008@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. . aged over 18 years.
2. underwent cardiac surgery.
3. classified as grade I or II according to NYHA classification of dyspnea by the physician.
4. does not complain of any physical or mental condition preventing him or her from participating.
5. agree to participate in the study.

Exclusion Criteria:

1. aged under 18 years.
2. classified as grade III or IV according to NYHA classification of dyspnea by the physician.
3. complain of any physical or mental condition preventing him or her from participating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The interventional arm (participants who will received the cardiac rehabilitation program; this arm will receive the cardiac rehabilitation program after completing the cardiac surgery and being assessed for eligibility.	Behavioral: Phase II comprehensive cardiac rehabilitation program; the program extends over 3 months after cardiac surgery. The program includes exercise, health education, and stress management. all content will be delivered to the participants through the WhatsApp application as instruction videos and short lectures. exercise will be gradually increased in terms of intensity, and duration. health education will cover topics like a healthy diet blood pressure, blood cholesterol control, smoking cessation …etc. stress management will include relaxation therapy, breathing control, behavioral change, and other strategies to control stress. Phone call follow-ups once weekly will be made by one of the research team to evaluate the adherence and answer potential questions All interventions are guided by universal guidelines like the Australian Cardiovascular Health and Rehabilitation Association (ACRA) and American Heart Association (AHA
No Intervention: the control arm (who will receive the usual care); the control group will receive the usual care ( the usual instruction and general advice from the physicians and the nurses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived health status	Short form-36 health survey will be used to measure the perceived health status	At base-line, after 3 months , and 1 month later
Anxiety level	Anxiety will be measured using the Hospital anxiety and depression scale(HADS)	At base-line, after 3 months , and 1 month later
Depression	Depression will be measured using the Hospital anxiety and depression scale(HADS)	At base-line, after 3 months , and 1 month later
90-day readmission rate	readmission rate will measured by reviewing patient medical record	after90 days

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Investigators: Principal Investigator: ALI SU HARBI, University Putra Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 9771044993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No