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IRCT20260811070623N1 IRCT 2026-08-29 Shahid Beheshti University of Medical Sciences The Effect of Microlearning and Teach-Back Education in Cardiac Patients Comparison of the Effects of Micro-learning and Teach-back Educational Methods in Discharge Planning on Self-efficacy and Quality of Life among Patients Admitted to the Cardiac Care Unit 2026-10-10 anticipated 84 Recruiting https://irct.ir/trial/92853 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be individually randomized to one of three study groups using variable block randomization with an equal allocation ratio of 1:1:1. Given the three-arm design, variable block sizes that are multiples of three (e.g., 3, 6, and 9) will be used to maintain balance among the three groups while minimizing the predictability of the allocation sequence. The random allocation sequence will be generated before the start of participant recruitment by a statistician using the R statistical software. Individual randomization will be used, and neither stratified nor cluster randomization will be performed. The generated allocation sequence will be kept by an individual who is independent of the research implementation team. To ensure allocation concealment, the allocation sequence will be placed in sequentially numbered, opaque, sealed envelopes (SNOSE). Each envelope will contain the allocation code for one participant. After eligibility has been confirmed, written informed consent has been obtained, and the baseline assessment and pre-intervention measurements have been completed, the envelope corresponding to the participant's enrollment order will be opened by the designated independent person to reveal the assigned study group. The researcher and other members of the study team responsible for participant recruitment and baseline assessment will have no access to the allocation sequence before assignment. Therefore, the assigned group cannot be predicted or altered before the participant is randomized. N/A Acute Coronary Syndrome. Intervention 1: Intervention group 1 (Microlearning): Participants will receive a discharge education package for patients with acute coronary syndrome based on the principles of microlearning and spaced learning. The educational package will consist of 14 short and independent units, with one unit delivered daily through an approved electronic platform for 14 consecutive days, starting on the first day after hospital discharge. Each unit will require approximately 3 to 10 minutes and will be presented as short text, images, infographics, audio files, or educational videos, according to the content. The educational content will cover disease awareness, medication use and adherence, healthy nutrition, physical activity and cardiac rehabilitation, risk factor management, warning signs, home care, treatment follow-up, lifestyle modification, and self-care. Before discharge, a 10 to 15 minute face-to-face session will be provided to explain how to use the electronic platform and receive the educational content. After receiving each unit, participants will be asked to confirm that they have viewed the content and answer brief review questions or educational scenarios to monitor content receipt and reinforce learning. Receipt of at least 80% of the educational units will be considered adequate adherence to the intervention. Intervention 2: Intervention group 2 (Teach-back): Participants will receive the same standardized discharge education package for patients with acute coronary syndrome using the Teach-back method. Education will be provided in three sessions during hospitalization in the coronary care unit and one additional session at discharge, with a total duration of approximately 75 to 110 minutes, delivered by the researcher. The educational content will cover disease awareness, medication use and adherence, healthy nutrition, physical activity and cardiac rehabilitation, risk factor management, warning signs, home care, treatment follow-up, lifestyle modification, and self-care. After each educational section, participants will be asked to explain the information and recommended self-care actions in their own words. If the response is incomplete or incorrect, the content will be re-explained using simpler language, followed by repeated Teach-back until the predefined learning criterion is achieved. Receipt of at least 80% of the educational content will be considered adequate adherence to the intervention. Intervention 3: Control group: Participants will receive usual discharge education according to the routine practice of the hospital and provided by healthcare staff. No study-specific education based on the research educational package will be provided to this group. The type and amount of usual education received during the study will be documented. After completion of follow-up, the educational content used in the study will be provided to participants in this group, if feasible and in accordance with ethical considerations. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data, Data Dictionary, Study Protocol, and Clinical Study Report. De-identified individual participant data may include baseline characteristics, group allocation, intervention adherence, and outcome data on cardiac self-efficacy and quality of life measured at baseline, one month, and two months after hospital discharge. Direct identifiers will be removed before data sharing. When: Access will be available beginning 6 months after publication of the primary study results and will remain available for 3 years. To whom: Qualified researchers affiliated with academic, research, healthcare, or scientific institutions may request access to the shared data and study documents, regardless of country or institution, provided that the request meets the requirements of the study data-sharing policy. Conditions: The data and documents may be used for scientifically and ethically justified secondary research, including replication, validation, methodological research, and additional analyses related to the study objectives. Requests must specify the research question, proposed analyses, and intended use of the data. Data may not be used to attempt re-identification of participants or for purposes that conflict with the informed consent provided by participants or applicable ethical and legal requirements. Where to obtain: Requests for access should be submitted to the principal investigator or the designated corresponding researcher using the official contact information provided in the trial registration record. The request should include the applicant's name and affiliation, contact information, research question, study objectives, proposed analyses, and intended use of the requested data or documents. How to obtain: Requests will be reviewed by the principal investigator and, when necessary, the relevant institutional ethics authority. The request will be assessed for scientific merit, ethical acceptability, consistency with participant consent, data privacy, and feasibility. Approved applicants will be required to agree to the terms of data use and confidentiality before receiving access. Data will be provided in a de-identified format through a secure method. The review process is expected to take up to 30 days after receipt of a complete request. Comments:
public Reza Heydari Chegeni
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Expressway, opposite Rajaie Cardiovascular Medical and Research Center, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 rezaheydari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Reza Heydari Chegeni
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr St., at the intersection with Ayatollah Hashemi Rafsanjani Expressway, opposite Rajaie Cardiovascular Medical and Research Center, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 rezaheydari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive diagnosis of acute coronary syndrome (ACS) confirmed by a cardiologist Age 18 years or older Hospitalization in the cardiac care unit (CCU) for at least 24 hours Full consciousness and the ability to communicate verbally Access to a smartphone and the ability to use it No cognitive impairment, severe psychiatric disorders, or physical disabilities that may interfere with participation in the educational intervention 18 years no limit Both Withdrawal of the participant from the study at any stage Development of hemodynamic instability or a critical condition that makes continued participation impossible Receipt of less than 80% of the educational content Failure to complete the research instruments Death of the patient during the study I24.9 Acute ischemic heart disease, unspecified Behavior Behavior Behavior Intervention group 1 (Microlearning): Participants will receive a discharge education package for patients with acute coronary syndrome based on the principles of microlearning and spaced learning. The educational package will consist of 14 short and independent units, with one unit delivered daily through an approved electronic platform for 14 consecutive days, starting on the first day after hospital discharge. Each unit will require approximately 3 to 10 minutes and will be presented as short text, images, infographics, audio files, or educational videos, according to the content. The educational content will cover disease awareness, medication use and adherence, healthy nutrition, physical activity and cardiac rehabilitation, risk factor management, warning signs, home care, treatment follow-up, lifestyle modification, and self-care. Before discharge, a 10 to 15 minute face-to-face session will be provided to explain how to use the electronic platform and receive the educational content. After receiving each unit, participants will be asked to confirm that they have viewed the content and answer brief review questions or educational scenarios to monitor content receipt and reinforce learning. Receipt of at least 80% of the educational units will be considered adequate adherence to the intervention. Intervention group 2 (Teach-back): Participants will receive the same standardized discharge education package for patients with acute coronary syndrome using the Teach-back method. Education will be provided in three sessions during hospitalization in the coronary care unit and one additional session at discharge, with a total duration of approximately 75 to 110 minutes, delivered by the researcher. The educational content will cover disease awareness, medication use and adherence, healthy nutrition, physical activity and cardiac rehabilitation, risk factor management, warning signs, home care, treatment follow-up, lifestyle modification, and self-care. After each educational section, participants will be asked to explain the information and recommended self-care actions in their own words. If the response is incomplete or incorrect, the content will be re-explained using simpler language, followed by repeated Teach-back until the predefined learning criterion is achieved. Receipt of at least 80% of the educational content will be considered adequate adherence to the intervention. Control group: Participants will receive usual discharge education according to the routine practice of the hospital and provided by healthcare staff. No study-specific education based on the research educational package will be provided to this group. The type and amount of usual education received during the study will be documented. After completion of follow-up, the educational content used in the study will be provided to participants in this group, if feasible and in accordance with ethical considerations. Cardiac self-efficacy score measured using the Cardiac Self-efficacy Scale. Timepoint: At baseline, one month, and two months after hospital discharge. Method of measurement: Cardiac Self-Efficacy Scale; CSES. Quality of life score among cardiac patients based on the MacNew Heart Disease Health-related Quality of Life Questionnaire. Timepoint: At baseline, one month, and two months after hospital discharge. Method of measurement: MacNew Heart Disease Health-related Quality of Life Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2026-07-20 Research Ethics Committees of School of Pharmacy and Nursing and Midwifery; Shahid Beheshti Universi Valiasr Street, at the intersection with Ayatollah Hashemi Rafsanjani Expressway, opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)