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

Depression Clinical Trial

Official title:

Impact of Rehabilitation on Anxiety, Depression, Perceived Health Status, and Readmission Among Patients After Coronary Artery Bypass in Jordan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118918
• Other study ID #: 9771044993
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: June 2024
• Source: Universiti Putra Malaysia
• Contact: ALI SU HARBI
• Phone: +962790070415
• Email: capalialharbi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Health Status

Intervention

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

Locations

Country	Name	City	State
Jordan	Prince Hamzah hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived health status	Short form-36 health survey will be used to measure the perceived health status..; The score ranges from 0 to 100. A high score defines a more favorable health state.	At base-line, after 12 weeks , and 1 month later
Primary	Anxiety level	Anxiety will be measured using the Hospital Anxiety and depression scale(HADS). The score ranges from 0 to 21. The highest score indicates worse symptoms.	At base-line, after 12 weeks, and 1 month later
Primary	Depression	Depression will be measured using the Hospital anxiety and depression scale(HADS).; The score ranged from 0 to 21. The highest score indicates worse symptoms.	At base-line, after 12 weeks , and 1 month later
Primary	90-day readmission rate	readmission rate will measured by reviewing patient medical record	after90 days