]>
IRCT20250414065319N1 IRCT 2025-04-22 Rasht University of Medical Sciences The effect of telenursing on resilience and caregiving burden 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 2025-09-06 anticipated 62 Complete https://irct.ir/trial/82926 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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, Blinding description: 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. N/A Resilience and caregiving burden in caregivers of elderly people undergoing hemodialysis treatment. Intervention 1: Intervention group: In the intervention group, three weekly telenursing training sessions are held for one month for caregivers of elderly people undergoing dialysis. These sessions include scientific and practical content to increase resilience and reduce caregiving burden. The content of the sessions is provided via telephone, PDF files, videos, and SMS. The first week is dedicated to familiarizing with caregiving needs, physical and psychological problems. The second week focuses on stress management and resilience. The third week emphasizes social and psychological support, and the fourth week focuses on time management and reducing caregiving burden. Training is also provided by telephone and in 10-15 minute intervals from 8 am to 8 pm. Finally, the impact of the interventions is examined by re-evaluating caregiving burden and resilience. Intervention 2: Control group: Control group: The control group in this study consists of caregivers of elderly people undergoing hemodialysis who receive only routine hospital training and no specific intervention such as family-centered telenursing training is applied to them. This training is provided in a general and standardized manner and includes basic information about kidney disease and hemodialysis treatment, but lacks telephone follow-up or specific educational content to reduce caregiving burden and increase resilience. The purpose of the control group is to compare the effects of the experimental group intervention with a group that receives only routine interventions, in order to assess the real effect of telenursing training on resilience and caregiving burden. Yes - There is a plan to make this available What will be shared: 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. When: 6 months after publication of the article To whom: Researchers working in academic and scientific institutions and medical centers Conditions: Data is accessible through academic coordination and direct communication with the person in charge. Where to obtain: Communication with the responsible person as well as academic institutions. How to obtain: Communication will be established via email and correspondence and a response will be provided within a week at most. Comments:
public Mahdi Fallah Heydarinezhad
Lahijan-Khazar St.-Khazar 6-No. 12
لاهیجان Iran (Islamic Republic of) 4477166595 +98 13 4233 1909 mehfhn6979@gmail.com Rasht University of Medical Sciences scientific Mahdi Fallah Heydarinezhad
Lahijan - Khazar St. - Khazar 6 - No. 12
Lahijan Iran (Islamic Republic of) 4414883941 +98 13 4233 1909 mehfhn6979@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Being eighteen years of age or older Taking primary responsibility for caring for an elderly person undergoing dialysis for at least one month Having at least basic reading and writing skills No problems with speech and hearing Not having psychological illnesses Having access to a landline and mobile phone for communicating via telenursing Having a minimum level of electronic literacy, including the ability to use a mobile phone (flat or smart) to communicate via text messages and phone calls. 18 years no limit Both Death of the patient Unwillingness to continue cooperation Caregivers' inability to communicate Lack of minimum literacy Taking care of another patient at the same time Absent from more than two meetings Other Other Intervention group: In the intervention group, three weekly telenursing training sessions are held for one month for caregivers of elderly people undergoing dialysis. These sessions include scientific and practical content to increase resilience and reduce caregiving burden. The content of the sessions is provided via telephone, PDF files, videos, and SMS. The first week is dedicated to familiarizing with caregiving needs, physical and psychological problems. The second week focuses on stress management and resilience. The third week emphasizes social and psychological support, and the fourth week focuses on time management and reducing caregiving burden. Training is also provided by telephone and in 10-15 minute intervals from 8 am to 8 pm. Finally, the impact of the interventions is examined by re-evaluating caregiving burden and resilience. Control group: Control group: The control group in this study consists of caregivers of elderly people undergoing hemodialysis who receive only routine hospital training and no specific intervention such as family-centered telenursing training is applied to them. This training is provided in a general and standardized manner and includes basic information about kidney disease and hemodialysis treatment, but lacks telephone follow-up or specific educational content to reduce caregiving burden and increase resilience. The purpose of the control group is to compare the effects of the experimental group intervention with a group that receives only routine interventions, in order to assess the real effect of telenursing training on resilience and caregiving burden. In the study "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," the primary outcome could be the resilience of caregivers of elderly people undergoing hemodialysis treatment, which is measured using the "Connor-Davidson Resilience Scale Questionnaire.". Timepoint: In the study "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," the time points for measuring resilience were at the beginning of the study (before the intervention) and after the intervention for 4 weeks. Method of measurement: In the study "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," the outcome variable was measured using the "Connor-Davidson Resilience Scale Questionnaire.". In the study "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," the primary outcome could be the caregiving burden of caregivers of elderly people undergoing hemodialysis treatment, which is measured using the "Zarit Psychological Burden Questionnaire.". Timepoint: In the study "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," the time points for measuring caregiving burden were at the beginning of the study (before the intervention) and after the intervention for 4 weeks. Method of measurement: In the study "Investigating the Effectiveness of Family-Centered Education Based on Telenursing on Resilience and Caregiving Burden of Elderly Caregivers Undergoing Hemodialysis Treatment: A Randomized Controlled Trial," the outcome variable (caregiving burden) was measured using the "Zarit Caregiving Burden Scale Questionnaire.". Rasht University of Medical Sciences Approved 2025-03-17 Ethics committee of Guilan University of Medical Sciences Langrud - Leila Kooh Road - Shahid Yaqoub Sheikhi Street - School of Nursing, Midwifery and Paramedical Sciences, East Guilan Rasht Guilan Iran (Islamic Republic of)