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IRCT20251110067943N1 IRCT 2025-12-27 Kermanshah University of Medical Sciences Effectiveness of a Digital Health Education Intervention Based on the Health Belief Model on Improving Self-Care in Patients After Open-Heart Surgery: A Randomized Controlled Trial The Effectiveness of a Digital Health Education Intervention Based on the Health Belief Model on Promoting Self-Care in Patients After Open-Heart Surgery: A Randomized Controlled Trial 2026-04-20 anticipated 90 Recruiting https://irct.ir/trial/87395 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling method is sequential and available based on entry and exit criteria and until the sample volume is completed. Allocation of people in intervention and control group is done by simple random allocation method and using Blockrand package of R software. After the random sequence is specified by the study epidemiologist, the researcher will put the people into 2 control and intervention groups based on the specified random sequence, Blinding description: This study is designed as a single-blind trial, meaning that participants will not be aware of the type of intervention they receive (intervention or control group). Due to the nature of the intervention, namely digital health education, blinding the researcher or educator is not feasible since they are directly delivering the training. However, participants’ lack of awareness regarding their group assignment helps reduce performance bias, and data analysis will be conducted by a blinded statistician to minimize assessment bias. This level of blinding is sufficient to ensure the validity of the results and to reduce bias in educational and behavioral intervention studies. N/A The patients, having undergone complex cardiac surgery. Intervention 1: Intervention group: Participants in the intervention group, in addition to receiving standard post-discharge pharmacological treatment, will receive a web-based educational package and participate in 8 online and offline discussion sessions over a period of two months. The intervention in this group will be conducted according to a pre-designed checklist by two facilitators. It should be noted that these facilitators do not play any role in assessing the study outcomes and have full supervision to ensure the correct and complete implementation of the intervention process. Intervention 2: Control group: All patients in the control group will receive the standard discharge education provided by the hospital at the time of discharge. However, unlike the intervention group, which receives both the standard education and the study-designed intervention, the control group will only receive the standard hospital discharge education. Participants who receive any education related to the intervention group will be excluded from the study. Yes - There is a plan to make this available What will be shared: Awareness, Attitude, and Self-Care Behavior in Patients Candidates for Heart Surgery When: six month after publishing the result To whom: other researchers Conditions: for re- analyses the data Where to obtain: to researchers by email How to obtain: maximum six month Comments:
public Hadi Darvishigilan
Kermanshah – Shahid Beheshti Boulevard – Central Building, Kermanshah University of Medical Sciences
Kermanshah Iran (Islamic Republic of) 6715847141 38358943-083 hadidarvishi2000@yahoo.com Kermanshah University of Medical Sciences scientific Hadi Darvishigilan
Kermanshah – Shahid Beheshti Boulevard – Central Building, Kermanshah University of Medical Sciences
Kermanshah Iran (Islamic Republic of) 6715847141 38358943-083 hadidarvishi2000@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients must have successfully undergone open-heart surgery and be in a stable clinical condition for at least five days after surgery (or based on the opinion of the relevant specialist). Be able to provide written informed consent to participate in the study (i.e., be literate in reading and writing). Have access to a smartphone or computer with an internet connection. Have the ability to use an online system.If the patient does not have internet literacy, one of the family members should agree to support the patient during the training sessions. Be willing to cover the cost of internet access; if they have financial difficulties, this cost will be provided through the project’s budget and the hospital’s research unit no limit no limit Both Have language impairments that prevent the patient from completing the questionnaire. Have an unstable clinical condition (for example, in the early postoperative period or in case of acute complications). Have serious cognitive problems such as Alzheimer’s disease or delirium. Have psychiatric disorders that impair judgment and cognition, such as schizophrenia. Have severe visual or hearing impairments that prevent participation in the educational sessions. Have specific medical conditions requiring special treatment that interfere with participation in the educational program, such as patients undergoing chemotherapy for cancer. I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris Prevention Prevention Intervention group: Participants in the intervention group, in addition to receiving standard post-discharge pharmacological treatment, will receive a web-based educational package and participate in 8 online and offline discussion sessions over a period of two months. The intervention in this group will be conducted according to a pre-designed checklist by two facilitators. It should be noted that these facilitators do not play any role in assessing the study outcomes and have full supervision to ensure the correct and complete implementation of the intervention process. Control group: All patients in the control group will receive the standard discharge education provided by the hospital at the time of discharge. However, unlike the intervention group, which receives both the standard education and the study-designed intervention, the control group will only receive the standard hospital discharge education. Participants who receive any education related to the intervention group will be excluded from the study. **Improvement in self-care behaviors** Measured using a validated self-care questionnaire specific to cardiac surgery patients, assessed at baseline and at the end of the intervention period.2. **Clinical indicators related to post-surgical recovery** Such as incidence of complications (e.g., infections, hospital readmissions) monitored during the follow-up period.3. **Quality of life** Assessed by a standardized tool (e.g., SF-36 or a cardiac-specific quality of life questionnaire) before and after the intervention. Timepoint: Immediately after the intervention and one month after the intervention and three months after the intervention. Method of measurement: Several questionnaires, particularly the **Self-Care of Coronary Heart Disease Inventory (SC-CHDI)**, and a **researcher-made self-care questionnaire for patients after open-heart surgery based on the Health Belief Model**. Kermanshah University of Medical Sciences Approved 2025-10-19 Ethics Committee of Kermanshah University of Medical Sciences Shahid Beheshti Boulevard – Central Building, Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)