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IRCT20260531069581N1 IRCT 2026-06-03 Mashhad University of Medical Sciences The Effect of an Interactive Video-Based Educational Program on Older Adults’ Functional Ability and Caregivers’ Fear of Older Adults’ Falls Following Hip Fracture Surgery VFH The Effect of an Interactive Video-Based Educational Program on Older Adults’ Functional Ability and Caregivers’ Fear of Older Adults’ Falls Following Hip Fracture Surgery 2026-05-31 anticipated 120 Complete https://irct.ir/trial/90490 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study is a two-arm randomized clinical trial in which 120 older adults undergoing hip fracture surgery and their caregivers will be randomly allocated to intervention and control groups. The control group will receive a written educational booklet, while the intervention group will receive a structured four-week interactive video-based education program delivered via the Eitaa messenger platform. The primary outcomes are the functional ability of the older adults and caregivers’ fear of falling. Assessments will be performed at baseline, immediately after the intervention, and one month later, Randomization description: In this study, participants will be allocated to the intervention and control groups using simple randomization at the individual level. The allocation ratio between the two groups is 1:1. Stratified or block randomization will not be used in this research. In the proposal text, the tool used to generate the random sequence and the operational details of allocation concealment have not been explicitly stated. The study is designed as single-blind, and only the participants will be blinded, Blinding description: This study is single-blind; participants are blinded to group allocation (intervention vs. control). Due to the nature of the educational intervention, the researcher/intervention provider is not blinded, and outcome assessors and data analysts are not blinded. N/A Hip fracture surgery. Intervention group: Interactive video-based education for caregivers of older adults undergoing hip fracture surgery. Yes - There is a plan to make this available What will be shared: Data Dictionary, Codebook, Data Collection Forms, and Coded/De-identified Demographic, Clinical, and Functional Data. These documents will include variable definitions, coding instructions, data file structure, demographic information of the older adult and caregiver, clinical information related to fracture and surgery, and outcome measures including SPPB and CFFI. All data will be coded and de-identified before any sharing, and no personally identifiable information will be disclosed. When: From 6 months after the official completion of the study and publication of the main results, for a period of 2 years. Access to the data will be possible after final data collection, cleaning, coding, and approval by the research team. To whom: Only researchers and postgraduate students affiliated with academic and scientific institutions who submit a written request stating the scientific purpose and a confidentiality commitment. Access to the data will be granted solely for research purposes and with approval from the research team. Conditions: Solely for scientific and research purposes, such as secondary analysis, data re-analysis, or educational use related to the study topic. Use of the data is subject to written approval from the research team, full compliance with confidentiality requirements, no attempt to re-identify participants, and proper citation of the original study in any scientific output. Commercial use of the data is not permitted. Where to obtain: Please send your written request to the scientific contact of the study, Dr. Najmeh Valizadeh Zare, via the following email: valizadehn@mums.ac.ir If needed, the general email of the School of Nursing and Midwifery, Mashhad University of Medical Sciences, may also be used: RAMResearch@mums.ac.ir How to obtain: The applicant must submit a written request including the intended purpose, analysis plan, and a confidentiality agreement. After review by the research team and upon approval, the de-identified data or relevant documents will be provided within 2 to 4 weeks. Comments: All participant information will be kept confidential and coded, and access to the data will be limited to the principal investigator and the research team. Names and personal identifiers will not be included in any report or publication, and results will be reported only in aggregate/group form.
public Fatemeh Khosravi Ghara Cheh
Management of Research Affairs, Central Building, Mashhad University of Medical Sciences, Daneshgah Street, Mashhad
Mashhad Iran (Islamic Republic of) ۹۱۳۷۹۱۳۵۱۴ +98 938 432 6847 khosravif4032@mums.ac.ir Mashhad University of Medical Sciences scientific Najmeh Valizadeh Zare
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Daneshgah Street, Mashhad
Mashhad Iran (Islamic Republic of) ۹۱۳۷۹۱۳۵۱۴ +98 938 432 6847 valizadehn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The older adult is aged 60 years or older. Has a history of hip fracture surgery. Is hospitalized. Discharge is planned within the next 48–72 hours. Is able to follow the home-based education program. The patient or the caregiver is able to receive/follow the training. Has access to a smartphone or a messaging application. Has an acceptable cognitive status .Provides written informed consent (patient). The caregiver also provides written informed consent. 60 years no limit Both Presence of acute medical complications that would make the intervention unsafe. Presence of severe visual or hearing impairment that would interfere with the training/education. Presence of severe cognitive impairment. Re-hospitalization of the patient during the intervention period. Likely non-completion of at least 25% of the educational sessions. Behavior Intervention group: Interactive video-based education for caregivers of older adults undergoing hip fracture surgery Functional ability in the elderly. Timepoint: At baseline (before the intervention), immediately after completion of the four-week training period, and one month after the end of the intervention. Method of measurement: Short Physical Performance Battery. The relationship between improvement in functional ability of older adults and reduction in caregivers' fear of falling after the educational intervention. Timepoint: At baseline before the intervention, immediately after completion of the four-week training period, and one month after the end of the intervention. Method of measurement: This relationship will be assessed by analyzing the scores obtained from the Short Physical Performance Battery and the Caregivers' Fear of Falling Index. Mashhad University of Medical Sciences Approved 2026-04-20 Ethics Committee of School of Nursing & Midwifery - Mashhad University of Medical Sciences Central Building, Research Affairs Office, Mashhad University of Medical Sciences, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)