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

NCT06118918 | Completed

• 1 other identifier: 9771044993
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Status; Anxiety; Depression; 90-day Readmission

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 90-day readmission rate

  readmission rate will measured by reviewing patient medical record

  after90 days

Study Arms (2)

The interventional arm (participants who will received the cardiac rehabilitation program

EXPERIMENTAL

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 control arm (who will receive the usual care)

NO INTERVENTION

the control group will receive the usual care ( the usual instruction and general advice from the physicians and the nurses)

Interventions

Phase II comprehensive cardiac rehabilitation program BEHAVIORAL

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

The interventional arm (participants who will received the cardiac rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Prince Hamzah hospital

Amman, 11946, Jordan

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• ALI SU HARBI

  University Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 3, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)