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IRCT20250428065506N1 IRCT 2026-06-03 Tarbiat Modares University Investigating the Effect of an Educational Intervention on Foot Care in Older Adults. The Effect of an Educational Program on the Adoption of Foot Care Behaviors among Older Adults: A Quasi‑Experimental Trial 2026-05-22 anticipated 120 Complete https://irct.ir/trial/83542 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Cluster randomization will be used in this study, with the health center considered as the unit of randomization. Two comparable urban health centers will be selected from those covered by the health network. The centers will then be allocated to the intervention and control groups using simple randomization. For this purpose, the names of the two centers will be written on identical pieces of paper, and through drawing lots, one center will be assigned to the intervention group and the other to the control group. After the group assignment of each center, older adults attending each center will be recruited using convenience sampling following assessment of the inclusion and exclusion criteria. The objectives of the study will be explained to eligible individuals, and written informed consent will be obtained from those who agree to participate. Participant recruitment in each group will continue until the required sample size is reached, and if the sample size is not initially achieved, enrollment of eligible participants will continue until the target number is completed. Since randomization is conducted at the cluster level, stratification will not be performed. Due to the nature of the educational intervention, allocation concealment and participant blinding will not be feasible. N/A Foot care. Intervention 1: Intervention group: This structured educational intervention, designed based on the Protection Motivation Theory (PMT), will be implemented with the aim of improving foot‑care behaviors among older adults. Participants will take part in a three‑week program consisting of six in‑person educational sessions (two sessions per week), with each session lasting between 60 and 120 minutes and delivered by the researcher at the Comprehensive Health Services Center. The session content includes education on common foot disorders in older adults, risk factors for foot problems, proper foot‑care practices (including daily inspection, foot hygiene, appropriate washing and drying techniques, and proper toenail trimming), guidance on selecting appropriate footwear and socks, identification of warning signs of foot complications, and strategies for fall prevention. The sessions will be delivered through lectures, group discussions, question‑and‑answer activities, and the use of educational materials and images. In addition, home safety will be assessed using a standardized home‑safety checklist, and tailored recommendations will be provided to reduce the risk of falls. Family members and relevant healthcare providers will also receive the necessary training to support foot‑care behaviors and fall‑prevention practices among older adults. Intervention 2: Control group: Participants in the control group will not receive any educational intervention. They will only complete the study questionnaires at the same five time points as the intervention group: baseline, immediately after the intervention, one month, three months, and six months post‑intervention. Yes - There is a plan to make this available What will be shared: Only a portion of the dataset—such as information related to the primary outcome—will be available for data sharing. When: The data access period will begin six months after the publication of the study results. To whom: The de‑identified data from this study will be accessible only to researchers affiliated with academic and scientific institutions Conditions: Access to the de‑identified data from this study will be available only to researchers affiliated with recognized academic or research institutions. A formal request outlining the research objective and proposed statistical analysis plan is required. Data may be used solely for non‑commercial, research purposes and only after signing a confidentiality agreement. All requests will be reviewed and approved by the study’s scientific committee prior to data release. Where to obtain: Dr. Alireza Heydarnia Tarbiat Modares University hidarnia@modares.ac.ir How to obtain: Researchers who are interested in accessing the study documents or datasets may submit a formal request to the principal investigator via email. The request should include the purpose of the study, the intended use of the data, and relevant institutional affiliation. All requests will be reviewed by the research team to ensure that the proposed use is consistent with ethical standards and participant confidentiality. After approval, the requested documents or de‑identified datasets will be shared with the applicant. The review and response process is expected to take approximately 2 to 4 weeks from the time the request is received. Comments:
public Dr. Alireza Heydarnia
Tarbiat Modares University, Nasr Bridge, Jalal Al‑Ahmad Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3833 hidarnia@modares.ac.ir Tarbiat Modares University scientific Dr. Alireza Heydarnia
Tarbiat Modares University, Nasr Bridge, Jalal Al‑Ahmad Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3833 hidarnia@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iran (Islamic Republic of) Age 65 years or older Functional independence and ability to perform activities of daily living Absence of cognitive impairment (defined as obtaining a score of 6 or above on the Persian version of the Mini‑Mental State Examination) Informed consent to participate in the study 65 years 90 years Both Individuals with diabetes Use of specific medications that cause dizziness or drowsiness in older adults Z71.9 Counseling, unspecified Behavior N/A Intervention group: This structured educational intervention, designed based on the Protection Motivation Theory (PMT), will be implemented with the aim of improving foot‑care behaviors among older adults. Participants will take part in a three‑week program consisting of six in‑person educational sessions (two sessions per week), with each session lasting between 60 and 120 minutes and delivered by the researcher at the Comprehensive Health Services Center. The session content includes education on common foot disorders in older adults, risk factors for foot problems, proper foot‑care practices (including daily inspection, foot hygiene, appropriate washing and drying techniques, and proper toenail trimming), guidance on selecting appropriate footwear and socks, identification of warning signs of foot complications, and strategies for fall prevention. The sessions will be delivered through lectures, group discussions, question‑and‑answer activities, and the use of educational materials and images. In addition, home safety will be assessed using a standardized home‑safety checklist, and tailored recommendations will be provided to reduce the risk of falls. Family members and relevant healthcare providers will also receive the necessary training to support foot‑care behaviors and fall‑prevention practices among older adults. Control group: Participants in the control group will not receive any educational intervention. They will only complete the study questionnaires at the same five time points as the intervention group: baseline, immediately after the intervention, one month, three months, and six months post‑intervention. Foot self‑care behavior among older adults. Timepoint: Foot self‑care behavior among older adults will be assessed at five time points: before the intervention, immediately after, and at 1, 3, and 6 months following the completion of the educational program. Method of measurement: Foot care behavior as a composite primary outcome, including daily foot inspection, regular washing, use of appropriate footwear, and checking water temperature before washing, measured using a self‑developed Foot Care Behavior Questionnaire. Quality of life. Timepoint: Before intervention (Day 0), immediately after intervention (Day 0), 1 month after intervention , 3 months after intervention, and 6 months after intervention . Method of measurement: Quality of life will be measured using the LEIPAD Quality of Life Questionnaire for older adults. This instrument consists of 31 items covering seven domains: physical functioning, self‑care, depression and anxiety, cognitive functioning, social functioning, sexual functioning, and life satisfaction. The items are rated on a four‑point Likert scale ranging from 0 (worst condition) to 3 (best condition). The total score is calculated by summing the item scores, with a possible range from 0 to 93. Higher scores indicate a better quality of life among older adults. Risk of falling. Timepoint: Before intervention (Day 0), immediately after intervention (Day 0), 1 month after intervention , 3 months after intervention, and 6 months after intervention . Method of measurement: Risk of falling will be assessed using the Comprehensive Fall Risk Assessment Questionnaire developed by Fabre et al. (2010). This instrument includes five subscales: fall history, medication use, physical function, vision, and environmental factors. Each domain is scored based on its respective items, and the total score is calculated by summing the scores of all subscales. Higher scores indicate a greater risk of falling among older adults. Social support. Timepoint: Before intervention (Day 0), immediately after intervention (Day 0), 1 month after intervention , 3 months after intervention, and 6 months after intervention . Method of measurement: Social support will be assessed using the Duke Social Support Index (DSSI), which consists of 19 items across two domains: emotional support and social interaction. The instrument is specifically designed for older populations. Items are rated on a multi‑point Likert scale, and the total score is obtained by summing the item scores. Higher scores represent greater perceived social support among older adults. Tarbiat Modares University Approved 2024-10-02 Ethics Committee of Tarbiat Modares University Tarbiat Modares University, Nasr Bridge, Jalal Al‑Ahmad Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)