Clinical trial NCT05551429: Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Official title: Factors Associated With Participation in Hospital-Based Cardiac Rehabilitation Program in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Cardiovascular Diseases
Cardiac Rehabilitation
Keywords: Acute Coronary Syndrome
Cardiac Rehabilitation
Myocardial Infarction
Participation
Health Literacy
Rehabilitation Barriers
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-75 years admitted to the coronary intensive care unit with the diagnosis of acute coronary syndrome

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of participation in the CR
timeFrame: Four weeks after discharge from ICU
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: At initial evaluation of the participant in ICU
measure: Measurement of hand grip strength
timeFrame: At initial evaluation of the participant in ICU
measure: Two minute Step Test
timeFrame: At initial evaluation of the participant in ICU
measure: World Health Organization Quality of Life Scale-Short Form
timeFrame: At initial evaluation of the participant in ICU
measure: Turkish Health Literacy Scale-32
timeFrame: At initial evaluation of the participant in ICU
measure: Cardiac Rehabilitation Barriers Scale-Turkish Version
timeFrame: Four weeks after discharge from ICU
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Gazi University Faculty of Medicine
name: Nesrin Demirsoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Levent Karataş, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: Coşkun, Özge Keniş, et al. Validity and reliability of the Turkish version of cardiac rehabilitation barriers scale. Gülhane Tip Dergisi 61.2 (2019): 59.
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.