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

This two-arm RCT evaluates a 4-week interactive video-based education program (via Eitaa) on older adults’ functional ability after hip fracture surgery and caregivers’ fear of falling.

A two-arm, parallel-group, single-blind randomized clinical trial will be conducted on 120 older adults undergoing hip fracture surgery and their caregivers. Participants will be allocated 1:1 to the intervention and control groups using simple randomization. This is a Phase II trial.

This single-blind trial includes 120 older adults after hip fracture surgery and their caregivers, recruited during hospitalization near discharge. The intervention starts two days before discharge and continues for 4 weeks as an interactive video-based education program via Eitaa.

-Inclusion criteria Older adults aged ≥60 years Hospitalized patients with a history of hip fracture surgery Planned discharge within 48–72 hours Ability to follow home-based training, with or without caregiver assistance Access to a smartphone / messenger app Acceptable cognitive status based on AMT Informed consent from the patient and caregiver - Exclusion criteria Acute medical complications making the intervention unsafe Readmission during the intervention period Severe visual or hearing impairment interfering with training Severe cognitive impairment Failure to complete at least 25% of the educational sessions

In this trial, 120 older adults after hip fracture surgery and their caregivers will be randomized to intervention or control. The intervention receives a 4-week video-based program via Eitaa; control receives a pamphlet.

Older adults’ functional ability will be assessed using the Short Physical Performance Battery (SPPB), and caregivers’ fear of the older adult falling will be measured using the CFFI questionnaire.

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.

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.

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.

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.

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.

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.

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

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.

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.