Investigating the effectiveness of family-centered education based on telenursing on the resilience and caregiving burden of caregivers of elderly people undergoing hemodialysis treatment: A randomized controlled trial

Determining the effectiveness of family-centered education based on telenursing on the resilience and caregiving burden of caregivers of elderly people undergoing hemodialysis treatment: A randomized controlled trial.

Randomized controlled trial, parallel group, single-blind, phase 0, 62 patients. Sealed Envelope Ltd was used for randomization.

In the intervention group, three weekly training sessions will be held via telenursing for one month. The aim of this training program is to increase the resilience of caregivers of elderly people undergoing dialysis and reduce their care burden. The sessions will be conducted over the phone and using digital resources such as PDF files, videos, and SMS. The research setting will include hemodialysis centers in hospitals in eastern Guilan. The list will be generated by the Sealed Envelope Ltd service and group allocation will be done using sealed envelopes.

Participants must be at least 18 years old, responsible for caring for an elderly person on dialysis for at least one month, literate, and free of speech, hearing, and mental health issues. They must also have access to a landline and mobile phone and some e-literacy. Elderly participants must be 60 or older, receiving dialysis, and have a home caregiver. Exclusion criteria include death, unwillingness to continue, participation in other studies, communication issues, caring for another patient, and missing more than two sessions.

A face-to-face meeting will be held before telenursing sessions begin. All sessions will be conducted via phone calls, text messages, and electronic content on a virtual platform (e.g., Telegram). The control group will receive routine care.

The main outcomes are resilience and caregiving burden of caregivers of elderly people on hemodialysis.

In this study, stratified random sampling will be employed to minimize demographic differences among the caregivers of the elderly and control confounding factors. All eligible caregivers will be randomly assigned to the intervention and control groups using a stratified block randomization method, with block sizes of 4 and 6, in a 1:1 ratio. To generate the randomization list, the online randomization service Sealed Envelope Ltd will be utilized. Allocation Concealment Method: Opaque, sealed envelopes with random sequences (SNOSE) will be used after determining the block randomization sequence. Based on the sample size of the study, a number of envelopes with aluminum foil wrappers (to prevent the visibility of the envelope contents) will be prepared. Each random sequence will be recorded on a card, and the cards will be placed in the envelopes in order. To maintain the random sequence, the envelopes will be numbered on the outside in the same order. Finally, the envelope flaps will be sealed, and the envelopes will be placed in a box in sequential order. During the participant enrollment phase, based on the order of participant entry into the study, one envelope will be opened in turn, revealing the assigned group for that participant.

The randomization list will be generated using the online randomization service Sealed Envelope Ltd. Allocation Concealment Method: Opaque, sealed envelopes with random sequences (SNOSE) will be used after determining the block randomization sequence. Based on the sample size of the study, a number of envelopes with aluminum foil wrappers (to prevent the visibility of the envelope contents) will be prepared. Each random sequence will be recorded on a card, and the cards will be placed in the envelopes in order. To maintain the random sequence, the envelopes will be numbered on the outside in the same order. Finally, the envelope flaps will be sealed, and the envelopes will be placed in a box in sequential order. At the time of participant enrollment, based on the order of eligible participants entering the study, one envelope will be opened in turn, revealing the assigned group for that participant.

The data related to this study include the results obtained from the Connor-Davidson Resilience and Zarit Caregiver Burden Questionnaires that were collected. These data include scores obtained from caregivers of elderly people undergoing hemodialysis treatment, from whom questionnaires measuring resilience and caregiving burden were received during the study. The data volume includes responses collected from participants and is stored in Excel and CSV formats. These data were collected specifically to analyze the effect of telenursing-based family-centered education on the resilience and caregiving burden of elderly caregivers and will be made available for research purposes. Also, the documentation includes clinical reports and educational data related to the interventions performed in the intervention and control groups, which are made available to academic and treatment centers in the form of PDF files and written reports.

6 months after publication of the article

Researchers working in academic and scientific institutions and medical centers

Data is accessible through academic coordination and direct communication with the person in charge.

Communication with the responsible person as well as academic institutions.

Communication will be established via email and correspondence and a response will be provided within a week at most.