Health StatusNCT06118918
Effect of Cardiac Rehabilitation on Health Status, Emotional Outcomes, and 90-day Readmission Rate Among Cardiac Surgery Patients
A study testing Phase II comprehensive cardiac rehabilitation program in people with Health Status and Anxiety, run by Universiti Putra Malaysia at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status, Anxiety, Depression
- What is being tested?
- Phase II comprehensive cardiac rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteJordan
- Study dates
- 3 Nov 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Rehabilitation on Anxiety, Depression, Perceived Health Status, and Readmission Among Patients After Coronary Artery Bypass 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.
- Conditions
- Health Status, Anxiety, Depression, 90-day Readmission
- Being tested
- Phase II comprehensive cardiac rehabilitation program
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase II comprehensive cardiac rehabilitation programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At base-line, after 12 weeks , and 1 month later
90-day readmission rate
readmission rate will measured by reviewing patient medical record
Measured: after90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start3 Nov 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALI SULEIMAN HARBI, Universiti Putra Malaysia
- Investigators
- ALI SU HARBI, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118918
- Sponsor's protocol ID
- 9771044993
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rehabilitation on Anxiety, Depression, Perceived Health Status, and Readmission Among Patients After Coronary Artery Bypass in Jordan
- ClinicalTrials.gov ID
- NCT06118918
- Acronym / sponsor ID
- 9771044993
- Conditions
- Health Status, Anxiety, Depression, 90-day Readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The interventional arm (participants who will received the cardiac rehabilitation program | Experimental | Behavioral: Phase II comprehensive cardiac rehabilitation programthis arm will receive the cardiac rehabilitation program after completing the cardiac surgery and being assessed for eligibility. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- . 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase II comprehensive cardiac rehabilitation programthe 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 | Behavioural | The interventional arm (participants who will received the cardiac rehabilitation program |
Primary outcome
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.
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.
90-day readmission rate
Time frame: after90 days
readmission rate will measured by reviewing patient medical record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALI SU HARBI principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase II comprehensive cardiac rehabilitation program in people with Health Status and Anxiety, run by Universiti Putra Malaysia at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived health status (time frame: At base-line, after 12 weeks , and 1 month later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.