Effect of a Health Literacy Based Educational Program on Health Seeking Behaviors among Older Adults: A Randomized Controlled Trial

To determine the effectiveness of the educational program in improving health seeking behaviors among community dwelling older adults.

A randomized controlled clinical trial with a parallel design will be conducted among 80 older adults, with 40 participants allocated to each group. Participants will be randomly allocated using block randomization. The random allocation sequence will be generated using the Randomization.com website.

This randomized clinical trial will be conducted at the Akbarabad Comprehensive Health Service Center in South Tehran. A total of 80 older adults will be randomly allocated to two groups, intervention and control. The intervention group will receive a group based educational program focused on improving health literacy over 6 weeks, while the control group will receive usual care. The primary outcome will be assessed before the intervention, immediately after the intervention, and two months after the intervention.

Community dwelling older adults aged 60 years and older, who are attending a Comprehensive Health Service Center in southern Tehran, have experienced an illness within the past 6 months, are Persian speaking, are able to communicate and provide informed consent, and have a score of 24 or higher on the Mini Mental State Examination will be eligible to participate in the study. Individuals with cognitive impairment or communication disorders, or those participating in a similar educational program, will not be eligible for participation.

Intervention group: Participants will receive a group-based educational program focused on enhancing health literacy. The program will be delivered over 6 weekly sessions in groups of 6 to 8 participants.

Health-Seeking Behavior Score

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.

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.

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.

Study Protocol: The complete study protocol will be made available for sharing after completion of the study. The protocol will include information on the study objectives and design, eligibility criteria, sampling and participant allocation procedures, intervention description, study outcomes, data collection methods, and statistical analysis plan. The shared protocol will not contain any personally identifiable or confidential participant information. Access will be provided in accordance with applicable ethical requirements and regulations governing the use and dissemination of research documents.

Access to the documents will begin 6 months after the completion of the study, and thereafter, upon request by eligible researchers and in compliance with ethical and confidentiality requirements, access to the documents will be provided.

Researchers and faculty members employed at universities and eligible research and scientific institutions can apply to receive study documents. Requests will be reviewed and approved by the principal investigator of the study, and in compliance with ethical requirements, confidentiality, and regulations related to the use of research documents. Upon approval, access to the documents will be granted.

Access to the study documents will be permitted solely for scientific and research purposes and within the scope of topics related to the study. Applicants must submit a request including their name and institutional affiliation, the purpose of the request, the intended use of the documents, and, where applicable, the intended manner of publication or use of the results derived from them. The use of the documents for commercial purposes, their transfer to third parties, or any use that is inconsistent with ethical requirements and regulations concerning the confidentiality of research information will not be permitted. Requests will be reviewed by the principal investigator of the study, and access to the documents will be provided upon approval.

Applicants may initially contact the principal investigator to submit a request for access. Requests should be submitted in writing by email and should include the applicant’s full name, institutional affiliation, purpose of the request, and intended use of the requested documents. Each request will be reviewed by the principal investigator. Upon approval, the requested documents will be made available to eligible applicants. Name of the responsible contact person: Zahra Yousefi Position: PhD Student in Nursing, Tehran University of Medical Sciences and Health Services Institutional affiliation: School of Nursing and Midwifery, Tehran University of Medical Sciences and Health Services Postal address: Tohid Square, Dr. Mirkhani Street (East Nosrat Street), Tehran, Iran Email: stu.yousefi@yahoo.com Telephone:+98 910 905 9966

The applicant submits their request in writing via the responsible researcher's email. The request will be reviewed for completeness of information and compliance of the intended use with the conditions set for access to the documents. The result of the review will be communicated to the applicant within a maximum of 30 working days. If the request is approved, the requested documents will be sent to the applicant via email after coordination and completion of the necessary procedures. If additional information is required, the review process will continue upon receipt of the needed information.