The effect of supportive educative program on quality of life and caregiver burden of patients with hip fracture

The effect of supportive training program on caregiving pressure and quality of life of caregivers of patients with hip fracture referred to the orthopedic department and clinic of Sina Hospital in Tehran.

Clinical trial with control group, single blind, randomized, phase on 70 patients. and the data was used through spss software.

Blinding was done in Sina Hospital, Tehran, in such a way that the participant and the analyst did not know the differences between the control and experimental groups

Inclusion criteria for caregivers included: kinship with the patient, active participation in home care of a patient with a hip fracture, willingness to participate, age over 18 years, literacy, and no mental or neurological disorders. Also, the absence of severe family conflicts and not being employed in caregiving professions were mandatory. For patients, hospitalization in the surgical or orthopedic departments of Sina Hospital due to a hip fracture and the presence of the primary caregiver at home were inclusion criteria. Exclusion criteria included lack of cooperation of caregivers, participation in similar educational programs, occurrence of a family crisis, voluntary withdrawal, absence from educational sessions, and death of patients.

Intervention group: Caregivers in this group underwent a structured support training program that included four training sessions on the principles of home care after hip fracture and problem-based coping skills. Control group: Caregivers in this group did not receive any direct training from the researcher.

Care pressure, quality of life, care education

This trial record is being updated following consultation with methodological experts and senior academic advisors regarding the study's clinical trial documentation. Based on their review and recommendations, several fields have been revised to more accurately and comprehensively reflect the study's design and conduct, thereby improving the methodological transparency and reporting quality of the trial. All amendments described below were finalized prior to the start of actual participant recruitment and were applied consistently and prospectively to all enrolled participants; none affected the study's ethical approval, primary research question, target sample size, or overall study design. The specific reason for each field update is as follows: Randomization description: Following consultation with methodological experts, the randomization description was revised to more precisely reflect the method implemented: block randomization (block size of four), generated by an independent statistician, with concurrent 1:1 enrollment of both groups. This refinement was recommended to improve baseline comparability between groups and to strengthen the rigor of the allocation process. The field has also been corrected to resolve an internal inconsistency in the original entry (which described 40 participants per group in the free-text description, inconsistent with the formally registered target sample size of 70). Intervention group description: Based on expert recommendations aimed at enhancing the comprehensiveness of the educational content delivered, the intervention was structured as six sessions rather than four, allowing more thorough and gradual coverage of both practical home-care skills and problem-focused emotional-coping strategies. This field has been updated to reflect the six-session structure, frequency (three sessions per week), and content areas as implemented.

In this study, block randomization (block size of four) was used to allocate participants to the intervention and control groups. The unit of randomization was individual. The random sequence was computer-generated by an independent statistician. The allocation ratio was 1:1 (control group: 35 participants; intervention group: 35 participants; total target sample size: 70). Recruitment for both groups occurred concurrently. Allocation concealment was ensured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE). Envelopes were opened exclusively by an independent research assistant who had no role in recruitment, intervention delivery, data collection, or statistical analysis only after the principal investigator had confirmed participant eligibility and obtained informed consent.

Clinical caregivers: Doctors, nurses and physiotherapists responsible for the treatment of patients were not involved in the research educational intervention and were (blinded to the grouping of companies). Data analyst (data analyst) The person responsible for the statistical analysis of the data had access only to the numerical coding of the groups (without knowledge of whether they were control or intervention). Therefore, complete blinding was observed in this role.

Our study, which was designed to investigate the effect of a supportive education program on the caregiving stress and quality of life of caregivers of patients with hip fractures referred to the orthopedic department and clinic of Sina Hospital in Tehran, includes a set of valuable documents and files that can be shared in accordance with ethical principles. First, the questionnaires that the samples completed in two stages before the intervention and 14 days after the last training are the main treasure trove of our data. These questionnaires include demographic information, caregiver caregiving stress questionnaires, and the SF-36 quality of life questionnaire, which were measured with standard tools. If we hide the identities of the individuals with anonymous coding, these data can be fully available to other researchers to conduct further analyses or compare the results with similar studies. In addition, the data analysis file prepared in SPSS software, which shows our statistical results; from means and standard deviations to tests such as t-tests. This file can also be shared, but perhaps only parts of it will be made public. We will probably only share the raw, more detailed data with others upon formal request and approval from the ethics committee, because participant confidentiality is a red line for us. As for the educational content; the educational booklet that we used and because it is also going to be given to the control group after the study, it is completely ready to be shared. Imagine this content as a small library that can reach universities and other researchers and help train nurses. In general, we would like our data and findings to be shared with the world, but with caution and care, so that both science advances and the privacy of the samples is preserved.

Access begins 6 months after results are published.

Researchers working in academic institutions and industry

Our anonymized data is a treasure trove that we can share with caution. Researchers can use this data for statistical analyses, such as comparing means or examining correlations, or use educational documentation to design similar courses. All of this will be under the supervision of an ethics committee and with a commitment to confidentiality. To request access, they must provide a formal letter stating the purpose of the research, ethical approval from a reputable institution, and a commitment not to publish the raw data so that we can safely share this information with them.

To Dr. Golnar Ghane, the project's faculty executive, golnarghane@gmail.com

In order for the documents or data files to reach the applicant, there are a few simple but important steps that need to be taken. Your request is like a letter that first reaches Dr. Golnar Ghane, the study administrator; simply apply via email or by calling the Tehran University of Medical Sciences School of Nursing and Midwifery. She will review your request—including the purpose of use and ethical documents—and if everything is complete, she will give initial approval. This usually takes a week. Next, the data must be anonymized; for example, student names and codes are removed to maintain privacy. This step, which is carried out by the research team, takes about 5 to 7 days. Then, the Ethics Committee of Tehran University of Medical Sciences takes a final look to make sure everything is in accordance with the principles—this also takes another week. Finally, the files (such as questionnaires or educational content) will be sent to you via email or secure drive. Overall, if your application is complete and flawless, it will take about 2 to 3 weeks for this treasure to reach you.