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IRCT20250123064495N3 IRCT 2026-10-08 Shahre-kord University of Medical Sciences Effects of cardiac rehabilitation in patients with acute coronary syndromes Effects of Home-Based Cardiac Rehabilitation Using Telenursing on Quality of Life and Treatment Adherence in Patients with Acute Coronary Syndromes 2026-11-20 anticipated 78 Pending https://irct.ir/trial/92950 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants in this study will be allocated to two intervention and control groups with a ratio of 1.1 using random allocation. To generate the random allocation sequence, an independent researcher not involved in conducting of the study will use the website https://www.random.org/. For this purpose, a random sequence including 78 letters (A: intervention and B: control) will be generated. To conceal the generated allocation sequence, each of the A or B codes of the generated sequence will be separately placed in opaque and sealed envelopes and the envelopes will be numbered consecutively from 1 to 78. After selecting eligible participants and obtaining informed consent, the envelopes will be opened in numerical order by the ward nurses who have no role in the study process, and individuals will be assigned to the intervention or control group based on the letter contained in the envelope, Blinding description: Considering the nature of the intervention, the participants, the principal researcher and the researchers who are responsible for implementing the intervention, collecting data and assessing outcomes, will not be blinded to the allocation of individuals to the study groups. The ward nurses will only assist in opening the allocation envelopes and have no role in the other stages of the study. On the other hand, the data analyst will be blinded to the allocation of the participants in the study. N/A Condition 1: Myocardial infarction. Condition 2: Unstable angina. Intervention 1: Intervention group: Seven weekly rehabilitation sessions, each lasting 40 minutes, will be conducted by a trained researcher. In the first session, the necessary assessments and review of the patients medical records will be conducted in person at the patients bedside. The next six sessions of the rehabilitation program will be conducted in groups through sending videos. These trainings will include 4 main areas of lifestyle changes (including management of dietary and medication regimen, comorbidities, and physical activity), control of signs and symptoms, care after invasive coronary procedures and psychological support. At the end of the 30-minute rehabilitation session, patients’ questions will be answered for 10 minutes. The main contents will also be provided to patients’ families, and the content of the rehabilitation sessions will be provided to participants in the form of a brochure at the beginning of the sessions. After completion of the rehabilitation sessions, monthly 20-minute follow-up sessions will be conducted for three months to review the training content, answer patients’ questions, and assess their adherence to the training. Intervention 2: Control group: Patients in the control group will receive routine care as before the study by the nurses and staff of the ward. The educational brochure prepared by the hospital will be provided to these patients at discharge, but the patients will not receive educational recommendations after discharge. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Majid Heidary Farsani
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Rahmatiye, Shahrekord
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3322 3893 Majidheidary1378@gmail.com Shahre-kord University of Medical Sciences scientific Jaefar Moghaddsi
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Rahmatiye, Shahrekord
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3334 1219 moghaddasi@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Age: 18-80 years Written informed consent for participate in study Confirmed medical diagnosis of acute coronary syndromes according to the diagnosis of a cardiologist and the clinical and paraclinical findings recorded in the patients' medical records Ejection fraction ≥ 20% according to patients echocardiography Ability to communicate in Persian Having a mobile phone and ability to use it 18 years 80 years Both Having class IV heart failure according to NYHA index Having severe valvular heart disorders or aortic dissection based on the diagnosis of a cardiologist, findings recorded in the medical records and echocardiography of the patients Presence of dysrhythmias preventing the safe performance of the cardiac rehabilitation program based on the assessment of a cardiologist Having other diseases preventing exercise such as severe musculoskeletal, neurological, renal or respiratory disorders based on medical assessment and patients' records Having severe psychiatric disorders based on information recorded in the medical records and the treating physician's opinion Need for coronary artery bypass surgery according to the angiography results I21 I20.0 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Unstable angina Rehabilitation N/A Intervention group: Seven weekly rehabilitation sessions, each lasting 40 minutes, will be conducted by a trained researcher. In the first session, the necessary assessments and review of the patients medical records will be conducted in person at the patients bedside. The next six sessions of the rehabilitation program will be conducted in groups through sending videos. These trainings will include 4 main areas of lifestyle changes (including management of dietary and medication regimen, comorbidities, and physical activity), control of signs and symptoms, care after invasive coronary procedures and psychological support. At the end of the 30-minute rehabilitation session, patients’ questions will be answered for 10 minutes. The main contents will also be provided to patients’ families, and the content of the rehabilitation sessions will be provided to participants in the form of a brochure at the beginning of the sessions. After completion of the rehabilitation sessions, monthly 20-minute follow-up sessions will be conducted for three months to review the training content, answer patients’ questions, and assess their adherence to the training. Control group: Patients in the control group will receive routine care as before the study by the nurses and staff of the ward. The educational brochure prepared by the hospital will be provided to these patients at discharge, but the patients will not receive educational recommendations after discharge. Treatment Adherence. Timepoint: Before, immediately and 6 months after intervention. Method of measurement: Coronary Artery Disease Treatment Adherence Scale. Quality of life. Timepoint: Before, immediately and 6 months after intervention. Method of measurement: Seattle angina questionnaire. Shahre-kord University of Medical Sciences Approved 2026-08-17 Ethics Committee of Shahrekord & Borujen School of Nursing & Midwifery & Shahrekord School of Health Shahrekord University of Medical Sciences, Central Headquarters, Ayatollah Kashani Blvd. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)