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IRCT20260829070827N1 IRCT 2026-09-07 Tehran University of Medical Sciences Effect of a Health Literacy Based Educational Program on Health Seeking Behaviors among Older Adults Effect of a Health Literacy Based Educational Program on Health Seeking Behaviors among Older Adults: A Randomized Controlled Trial 2026-09-19 anticipated 80 Recruiting https://irct.ir/trial/93041 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible participants will be individually allocated in a 1:1 ratio to the intervention or control group after obtaining informed consent and completing the baseline assessment. Block randomization with a fixed block size of 4 will be used. The random sequence will be generated using Randomization.com based on the six possible arrangements within blocks of 4 participants: AABB, ABAB, BBAA, BABA, ABBA, and BAAB. No stratified randomization will be used, and the individual participant will be the unit of randomization. To ensure allocation concealment, 80 opaque, non-transparent, sequentially numbered, and sealed envelopes will be prepared, with an allocation card placed inside each envelope. The envelopes will be kept by a person who is not involved in participant recruitment or baseline assessment. After eligibility is confirmed, informed consent is obtained, and the baseline assessment is completed, the envelope corresponding to the participant’s study number will be opened, Blinding description: Participants will not be blinded to their group allocation because the intervention involves participation in a group-based educational program. The researcher responsible for delivering the intervention will also not be blinded to group allocation. The researcher responsible for collecting the outcome data will not be blinded if the same researcher administers the questionnaires at post-intervention and follow-up assessments. No healthcare personnel responsible for routine care will be involved in group allocation or delivery of the intervention. Data analysis will be conducted using coded group identifiers only if the analyst is not informed of the meaning of the group codes. No independent Data Safety and Monitoring Committee is planned for this study. N/A Health-seeking behavior in older adults. Intervention group: Participants in the intervention group will receive a group-based educational program aimed at improving health-seeking behaviors through the enhancement of health literacy. The program is designed based on Nutbeam’s three-level model of health literacy, including functional, interactive, and critical health literacy. The content of the program was developed based on the findings of the qualitative study, the results of the scoping review, and the prioritization of modifiable challenges identified in the Delphi study.The intervention will be delivered over **six weekly group sessions for groups of 6–8 participants . Each session will generally last 60–75 minutes, while the fourth session, depending on the educational content, may last up to 100 minutes. The sessions will be conducted at a Comprehensive Health Service Center by the researcher.The content of the sessions will include education on concepts and skills related to health-seeking behaviors, improving the ability to obtain and understand health information, strengthening communication skills and the ability to ask questions of healthcare providers, using the teach-back method, recognizing the appropriate time and way to seek healthcare services, evaluating and comparing health information and recommendations, strengthening informed decision-making skills, identifying and addressing barriers to health-seeking behaviors, goal setting and action planning, self-monitoring, and strengthening the continuation of desirable behaviors.Active and participatory educational methods, including group discussion, scenario-based learning, role-play, practical exercises, teach-back, action planning, self-monitoring, problem-solving, and peer learning, will be used to conduct the sessions. The educational content will be tailored to the participants’ health literacy levels and needs as older adults. Participants in the intervention group will attend all six educational sessions, and the implementation of the sessions and participants’ engagement will be documented using an intervention fidelity checklist.. No - There is not a plan to make this available Justification or reason for not sharing IPD is Given the nature of the collected data and the requirements related to maintaining the confidentiality and privacy of the participants, there is no plan to share individual participants' data in this study. The research data will be used solely for the specified research purposes and will be kept in accordance with ethical requirements and regulations related to information confidentiality.
public Zahra Yousefi
Dr. Mirkhani St. (East Nosrat St.), Tohid Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 stu.yousefi@yahoo.com Tehran University of Medical Sciences scientific Zahra Yousefi
Dr. Mirkhani St. (East Nosrat St.), Tohid Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 stu.yousefi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 60 years or older Living in the community and attending Akbarabad Comprehensive Health Service Center in South Tehran Having experienced an illness during the past 6 months Fluency in Persian Having the ability to communicate and participate in the educational sessions A score of 24 or higher on the Mini Mental State Examination Providing written informed consent to participate in the study 60 years no limit Both Having a cognitive impairment that affects the ability to understand and participate in the educational program. Having a psychological disorder that affects the ability to communicate and participate in the study. Having a visual or hearing impairment that affects communication and participation in the study. Concurrent participation in a similar educational program on health-seeking behaviors or health literacy. Behavior Intervention group: Participants in the intervention group will receive a group-based educational program aimed at improving health-seeking behaviors through the enhancement of health literacy. The program is designed based on Nutbeam’s three-level model of health literacy, including functional, interactive, and critical health literacy. The content of the program was developed based on the findings of the qualitative study, the results of the scoping review, and the prioritization of modifiable challenges identified in the Delphi study.The intervention will be delivered over **six weekly group sessions for groups of 6–8 participants . Each session will generally last 60–75 minutes, while the fourth session, depending on the educational content, may last up to 100 minutes. The sessions will be conducted at a Comprehensive Health Service Center by the researcher.The content of the sessions will include education on concepts and skills related to health-seeking behaviors, improving the ability to obtain and understand health information, strengthening communication skills and the ability to ask questions of healthcare providers, using the teach-back method, recognizing the appropriate time and way to seek healthcare services, evaluating and comparing health information and recommendations, strengthening informed decision-making skills, identifying and addressing barriers to health-seeking behaviors, goal setting and action planning, self-monitoring, and strengthening the continuation of desirable behaviors.Active and participatory educational methods, including group discussion, scenario-based learning, role-play, practical exercises, teach-back, action planning, self-monitoring, problem-solving, and peer learning, will be used to conduct the sessions. The educational content will be tailored to the participants’ health literacy levels and needs as older adults. Participants in the intervention group will attend all six educational sessions, and the implementation of the sessions and participants’ engagement will be documented using an intervention fidelity checklist. Health-Seeking Behavior Score: The total score obtained from the Health-Seeking Behavior Scale (HSBS) in the elderly. This variable is measured using the total questionnaire score at specified times before and after the intervention, and the change in score will be compared between the intervention and control groups. A higher score indicates a higher level of health-seeking behaviors. Timepoint: The score of health-seeking behaviors will be measured at three time points in both the intervention and control groups: (1) at the beginning of the study and before the start of the intervention (pre-test), (2) immediately after the end of the six-week intervention (post-test), and (3) two months after the end of the intervention (follow-up). Method of measurement: Health-seeking behavior will be measured using the Health Seeking Behavior Scale developed by Kıraç and Öztürk. The final version of the scale consists of 12 items across three dimensions: online health-seeking behavior (6 items), professional health-seeking behavior (3 items), and traditional health-seeking behavior (3 items). The items are rated using a Likert-type response scale, with higher scores indicating a higher level of health-seeking behavior. In the present study, the Persian version of the scale will be used following translation and cultural adaptation and assessment of its validity and reliability. Tehran University of Medical Sciences Approved 2024-05-08 Ethics Committee of Tehran University of Medical Sciences (TUMS) Tohid Square, Dr. Mirkhani Street (East Nosrat Street), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)