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

Comparison of the Effects of Microlearning and Teach-back Methods in Discharge Education on Self-efficacy and Quality of Life among Patients Hospitalized in the Cardiac Care Unit

A three-arm parallel randomized controlled trial with a 1:1:1 allocation ratio will be conducted. Variable block randomization will be used. Participants and the intervention provider cannot be blinded; however, data analysis will be performed by a person unaware of group allocation. Clinical trial phase: Not applicable.

The study will be conducted in cardiac care units of teaching hospitals affiliated with Shahid Beheshti University of Medical Sciences in Tehran. Outcomes will be assessed at baseline, one month, and two months after discharge.

Participants will include patients aged 18 years and older with a confirmed diagnosis of acute coronary syndrome, hospitalized in the coronary care unit for at least 24 hours, who are fully conscious, able to communicate verbally, and have access to a smartphone. Patients with cognitive impairment or severe psychiatric illness, hemodynamic instability, transfer to another healthcare facility, failure to complete the study, or death during the study will be excluded.

The microlearning group will receive 14 short educational units over 14 consecutive days after discharge. The teach back group will receive the same educational content during three inpatient sessions and one discharge session using the teach back method. The usual care group will receive routine discharge education.

Cardiac self-efficacy; quality of life

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.

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.

Access will be available beginning 6 months after publication of the primary study results and will remain available for 3 years.

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.

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.

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.

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.