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

In this study, simple randomization was used to allocate participants into intervention and control groups. The unit of randomization was individual; that is, each eligible caregiver was assigned independently. The random sequence was generated using SPSS software (version 26). The principal investigator created a numbered list of eligible participants and applied the "Random Sample of Cases" function to assign individuals randomly to either the intervention or control group in a 1:1 ratio (40 participants per group). To prevent data contamination between groups, recruitment was sequential in time: first, all control group participants were recruited, followed by the intervention group. Allocation concealment was ensured by placing the final allocation list into sealed, opaque, numbered envelopes. These envelopes were handled solely by an independent research assistant who was not involved in data collection or analysis. The statistical analyst was blinded to group assignments (single-blind design). Stratified or block randomization was not applied in this study, as preliminary analysis indicated no significant imbalance in key baseline variables across groups.

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.