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Clinical Trials/NCT06118918
NCT06118918CompletedNot Applicable

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

Universiti Putra Malaysia1 site in 1 country122 target enrollmentStarted: November 3, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
122
Locations
1
Primary Endpoint
Perceived health status

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •. 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.

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Phase II comprehensive cardiac rehabilitation program (Behavioral)

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)

Outcomes

Primary Outcomes

Perceived health status

Time Frame: At base-line, after 12 weeks , and 1 month later

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.

90-day readmission rate

Time Frame: after90 days

readmission rate will measured by reviewing patient medical record

Anxiety level

Time Frame: At base-line, after 12 weeks, and 1 month later

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.

Depression

Time Frame: At base-line, after 12 weeks , and 1 month later

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ALI SULEIMAN HARBI

Principal Investigator

Universiti Putra Malaysia

Study Sites (1)

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