Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome

Cardiovascular Diseases Clinical Trial

Official title:

Factors Associated With Participation in Hospital-Based Cardiac Rehabilitation Program in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551429
• Other study ID #: Participation in Cardiac Rehab
• Status: Completed
• Start date: September 22, 2022
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute coronary syndrome (ACS) is one of the most important causes of mortality and morbidity all over the world. Cardiac rehabilitation (CR) is a crucial part of secondary prevention and optimal care of patients with ACS. However, the participation rate in CR after ACS is far from expected. In our study, we will aim to examine the rate of participation in cardiac rehabilitation and the factors affecting it in patients followed up for acute coronary syndrome in the coronary intensive care unit of our hospital. Our main hypothesis is that the lower rate of participation in cardiac rehabilitation in patients with acute coronary syndrome is associated with one or more of that older age, female gender, multimorbidity, poor functional capacity, lower health literacy level or quality of life levels.

Description:

Acute coronary syndrome (ACS) is an umbrella term comprising unstable angina, myocardial infarction (MI) with or without ST-segment elevation, and sudden cardiac death because of acute myocardial ischemia. ACS is one of the most important causes of mortality and morbidity all over the world. Today, cardiac rehabilitation has become an integral part of the medical care and secondary prevention programs of cardiovascular diseases including ACS. Cardiac rehabilitation (CR) is a long-term comprehensive rehabilitation program that includes but not limited to patient evaluation, determination of risk profile, patient-tailored exercise training, and behavioural and lifestyle changes aiming at risk reduction in cooperation with many disciplines. It consists of comprehensive interventions. Despite its known benefits and recommended in national and international guidelines, the participation rate in cardiac rehabilitation is lower than expected. Studies involving different countries and societies showed that lower participation was associated with inadequate referral, female gender, poor motivation, older age, comorbidities, difficulty in transportation, and poor socioeconomic status. It has been suggested that setting up a CR appointment before discharge via clinical visits by the CR team or automatic referral systems, increasing patient interest and knowledge through written invitations and brochures, and providing support for transportation may increase participation in CR. In our country, there are not enough studies addressing the success of participation and compliance in cardiac rehabilitation. In this study, we aim to determine patient related factors associated with low participation in CR in patients admitted to our coronary intensive care unit (ICU) with ACS diagnosis. All patients included in this study will be comprehensively informed about CR and the initial CR session will be scheduled to minimize effect of inadequate referral.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 12, 2024
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Being hospitalized in the coronary intensive care unit with the diagnosis of acute coronary syndrome
• Being able to walk and get up from a chair without the support of a person
• Agree to take part in the study

Exclusion Criteria:

• Presence of any conditions that prevent exercise training (severe orthopaedic, neurological or rheumatological disease, acute infection, acute pericarditis, endocrine and metabolic disorders, etc.)
• Presence of neuropsychiatric diseases or conditions that may prevent cooperation
• Persisting unstable angina
• Having severe stenosis or insufficiency of heart valve
• Congenital structural heart diseases
• Presence of decompensated heart failure
• Uncontrolled arrhythmias that may cause hemodynamic instability during exercise
• Exercise contraindication decision of the cardiologist

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Rehabilitation
• Cardiovascular Diseases
• Syndrome

Intervention

Behavioral:
• Invitation to the CR
Oral and written information emphasise the benefits of cardiac rehabilitation in terms of treatment of heart diseases, increasing functional capacity, reducing morbidity and mortality, and enhancing secondary prevention. Introducing the scope and method of administration of CR to patients. Setting up the appointment for the initial CR session four weeks later.

Locations

Country	Name	City	State
Turkey	Gazi University Hospital, Department of Physical Medicine and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15. — View Citation

Coskun, Özge Kenis, et al. Validity and reliability of the Turkish version of cardiac rehabilitation barriers scale. Gu¨lhane Tip Dergisi 61.2 (2019): 59.

Grace SL, Krepostman S, Brooks D, Jaglal S, Abramson BL, Scholey P, Suskin N, Arthur H, Stewart DE. Referral to and discharge from cardiac rehabilitation: key informant views on continuity of care. J Eval Clin Pract. 2006 Apr;12(2):155-63. doi: 10.1111/j.1365-2753.2006.00528.x. — View Citation

Okyay, P., et al. A new Health Literacy Scale: Turkish Health Literacy Scale and its psychometric properties: Pinar Okyay. The European Journal of Public Health 25.suppl_3 (2015): ckv175-220.

Pio CSA, Chaves G, Davies P, Taylor R, Grace S. Interventions to Promote Patient Utilization of Cardiac Rehabilitation: Cochrane Systematic Review and Meta-Analysis. J Clin Med. 2019 Feb 5;8(2):189. doi: 10.3390/jcm8020189. — View Citation

Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participation in the CR	Number of patients admitted to the first CR session four weeks after discharge from the ICU	Four weeks after discharge from ICU
Secondary	Timed Up and Go Test	It is a test that evaluates balance, mobility and lower extremity muscle strength, which includes getting up from a chair, walking 3 meters, turning back and sitting on the chair again. After an adaptation trial, the test is performed twice, including a rest period between trials. Patients are allowed to use any assistive device such as a cane or walker. The main result is the average duration of the two trials. A longer test time indicates worse performance.	At initial evaluation of the participant in ICU
Secondary	Measurement of hand grip strength	Hand grip strength is an important indicator of overall muscle strength. Measurements will be performed using a Jamar dynamometer, while sitting, with the arm just next to the trunk, the elbow flexed to 90 degrees, and the forearm and wrist in a neutral position, as recommended by the American Association of Hand Therapists. Three measurements will be performed, including one-minute intervals between trials. The highest result of the three trials will be accepted.	At initial evaluation of the participant in ICU
Secondary	Two minute Step Test	This test is used to evaluate the endurance of lower extremity muscles. The patient is asked to stand next to a wall. The midpoint of the distance between the patient's iliac crest and the knee is measured and marked on the wall. On the signal "go" the patient begins stepping (not running) in place, raising each knee to the mark on the wall, as many times as possible in the 2 minutes. The number of times the right knee reaches the required height is counted. If the proper knee height cannot be maintained, the patient is asked to slow down or to stop until he/she can regain the proper form, while keeping the stopwatch running.	At initial evaluation of the participant in ICU
Secondary	World Health Organization Quality of Life Scale-Short Form	This scale is used for a brief assessment of the quality of life in routine clinical practice, large-scale epidemiological studies, or clinical trials. It comprises 27 questions that evaluate general health status, physical health, psychological status, social relations and environmental issues sub-titles. Each question receives an answer corresponding to 1-5 points. The percentages of the scores obtained from each sub-title allow us to make a quantitative interpretation of domains of the quality of life.	At initial evaluation of the participant in ICU
Secondary	Turkish Health Literacy Scale-32	Turkish Health Literacy Scale-32 ("Türk Saglik Okuryazarlik Ölçegi" in Turkish) is a survey comprising 32 questions that measure health literacy. It is derived from the Turkish version of The European Health Literacy Survey, which consists of 47 questions. It has been reported to be valid and reliable in Turkish population.; The survey addresses accessing, understanding, evaluating and using/applying health-related information. Each question is answered by choosing one of the options "very easy", "easy", "difficult" "very difficult" or "I don't know", corresponding to 4, 3, 2, 1 and null points, respectively. The mean score is calculated after excluding questions with invalid or "I don't know" answers. The index is determined following the formula "index = (mean score - 1) x (50/3)" A score of 0-25 indicates insufficient, >25 to 33 indicates limited, >33 to 42 indicates adequate, and >42 to 50 indicates excellent health literacy.	At initial evaluation of the participant in ICU
Secondary	Cardiac Rehabilitation Barriers Scale-Turkish Version	It is a questionnaire that aims to determine the reason(s) for not attending or missing the CR sessions. Each of the 21 possible reasons is answered by the patient on a 1-5 Likert scale (strongly disagree-disagree-decided-agree-strongly disagree). The last question has an open-ended answer option for patient to report other reasons. Turkish version of this survey were found to be valid and reliable by Coskun et al. in 2019.; Patients who do not attend to their CR appointment at fourth week after discharge will be called and the Cardiac Rehabilitation Barriers Scale-Turkish Version will be applied.	Four weeks after discharge from ICU

External Links

•   Turkish Health Literacy Survey (TSOY-32)
•   WHO methods and data sources for country-level causes of death 2000-2019