The clinical trial was carried out using a parallel controlled design and focused on a cohort of 60 caregivers responsible for patients undergoing hemodialysis in an Iranian healthcare setting (Fig. 1).

The eligibility criteria for caregivers encompassed a willingness to engage in the study and provide informed consent, serving as the primary caregiver for the patient, possessing a minimum of six months of regular dialysis experience for the patient, proficiency in reading and writing, absence of speech or hearing impairments, capability to make phone calls, lack of specific psychological issues, and not being a member of the healthcare team. As for the peers, the entry criteria involved being accepted and esteemed by other group members, demonstrating interest and motivation to fulfill a role, ability to communicate effectively and conduct meetings, willingness to instruct others, absence of a history of mental or cognitive disorders, higher level of health literacy, greater compatibility with care-related issues, and possession of appropriate communication skills.

To implement the intervention, six caregivers were selected from the Hefdeh Shahrivar Hemodialysis Center in Mashhad city based on rigorous peer selection criteria. These chosen peers underwent thorough individual evaluations during a dedicated meeting, separate from the other caregivers. In this meeting, comprehensive explanations were provided regarding various aspects of the care burden, the crucial role of peers in conducting meetings, scheduling support sessions, and the ultimate objectives of these gatherings.

The researcher, an experienced community health nurse, meticulously assessed the performance, knowledge, and attitude of the peers to ensure the highest level of competence and credibility.

The peers were evaluated by the community health nurse based on their communication skills, empathy, and ability to provide support. The assessment included role-playing scenarios and feedback sessions to ensure they met the criteria for effective peer support. This evaluation aimed to identify any potential scientific, informational, or skill deficiencies, as well as areas where caregivers may lack awareness or understanding. Furthermore, the meeting encompassed a comprehensive discussion on effective techniques for conducting both needs assessment meetings and support sessions, focusing on addressing the needs of the caregivers.

Initially, the researcher imparted valuable knowledge to the peers on how to skillfully facilitate a needs assessment meeting, employing brainstorming techniques. The peers were actively encouraged to engage in attentive listening, fostering a safe and non-judgmental environment for caregivers to freely express their concerns and challenges. The primary focus was on identifying genuine needs and conducting scientific examinations of problem-solving approaches.

“In the intervention group, a comprehensive program consisting of eight training sessions was conducted for caregivers of patients receiving hemodialysis. These sessions were held twice a week, with each session lasting a maximum of one hour, spanning over a period of four weeks. The training sessions were conducted in small groups, comprising a maximum of five caregivers per group. Each training session was dedicated to a particular topic, carefully selected based on the expressed needs and interests of the caregivers during the initial meeting. Priority was given to topics that were frequently raised and expressed by multiple individuals during the needs assessment session. The intended content of the sessions included dietary guidelines, fluid restrictions, medication management, transportation logistics, coping with stress, addressing social isolation, managing financial challenges, and strategies for improving mental health and emotional well-being.”

The topics for the peer support group meetings were carefully selected based on the expressed needs and interests of the caregivers during the initial meeting. Priority was given to topics that were frequently raised and expressed by multiple individuals during the needs assessment session.

During the support group meetings, a combination of argumentative debate and nominal group techniques was utilized to promote comprehensive deliberation of all the issues raised. Each member of the group was encouraged to express their thoughts and actively engage in the discussion. The nurse and peer caregivers shared their own experiences and provided valuable feedback on the issues being discussed. Additionally, caregivers were prompted to think critically, evaluate and analyze each other’s proposed solutions, and offer further comments to enhance the suggested solutions and shared experiences.

Throughout each session, the caregivers engaged in discourse and prioritized issues based on the findings of the needs assessment. They exchanged insights and received input from previous support sessions. Reflection on the application of previous session materials occurred as caregivers deliberated. In the event that novel concerns emerged, the nurse and peers carefully assessed them and proposed potential resolutions.

The topics covered in the peer support group sessions included a wide range of issues identified during the needs assessment meeting, such as depression, anxiety, isolation, mental fatigue, decreased motivation, lack of time, need for social support, treatment and care costs, lack of insurance, reduced working hours and income due to caregiving, lack of sleep, anorexia, malnutrition, and various other physical and psychological needs.

The instruments utilized in this study included the demographic information questionnaire and Zarit care burden questionnaire.

The Zarit Care Burden Questionnaire, comprising 22 questions to assess individuals’ sentiments towards caring for another person, was employed. The questionnaire evaluates four dimensions: personal, social, emotional, and economic. The intensity of caregiving pressure is measured using a 5-point Likert scale, ranging from ‘never’ to ‘always’, with corresponding scores of 0 to 4. The total score can range from 0 to 88. On the care pressure scale, a score of 0–20 indicates no or low pressure, 21–40 indicates mild to moderate pressure, 41–60 indicates moderate to severe pressure, and 61–88 indicates severe care pressure.

The reliability of the Zarit Burden Care Questionnaire has been validated in previous studies, including an internal consistency (Cronbach’s alpha) of 0.91 in the psychometric evaluation study conducted by Gonçalves-Pereira (2017), good reliability through internal consistency and retest (r = 0.9) in Jennifer Davis et al.‘s study (2013), and a reliability of 0.94 using the retest method in Navidian’s study (2008) [50,51,52].

To determine the validity of the instruments, content validity was used in a way that the instruments were reviewed by ten members of the scientific board of the Nursing and Midwifery Faculty in Mashhad, and after final revisions, they were utilized. The reliability of the instruments was established by calculating Cronbach’s alpha, which resulted in a 0.90 coefficient after being administered to 20 research units who met the conditions for participating in the study.

The instruments used for data collection were revised and amended as necessary to ensure their suitability for the study population.

To determine the sample size, due to the lack of similar study results available, a pilot study was conducted on 10 people in each group using a mean comparison formula with a 95% confidence coefficient and an 80% test power for all study outcomes. The results of the pilot study were included in the final study to ensure comprehensive analysis and robustness of the data. The highest calculated value was related to stress, estimated at 25 people per group. For greater assurance and to enable comparison in subgroups, accounting for a 20% dropout rate, 30 people were included in each group, making the final sample size 60 people in total.

The participants were randomly assigned to the intervention and control groups using the randomization tool available at http://randomization.com, which ensures unbiased and reproducible group assignments. A concealed allocation approach was utilized with sealed envelopes. Random sequences were written as codes A and B on small cards and placed inside the envelopes. When a hemodialysis patient caregiver meeting the research criteria was identified, an envelope was opened, and the code inside determined the group assignment.

Caregivers were isolated from one another during the study by being assigned based on their geographic location, ensuring no interaction between participants. This isolation method minimized the risk of cross-contamination and maintained the integrity of the study results. Additionally, patients under the caregivers’ supervision were located in single rooms within the medical facility, ensuring that they had no direct physical contact with each other. This further helped in maintaining the study’s rigor and reliability.

The descriptive statistics (viz., frequency distribution, mean, and standard deviation) were used to describe and categorize the data. Inferential statistics including the Chi-square test, independent-samples t-test, and Mann-Whitney U test were used to test the research hypothesis. Wilcoxon signed-rank test and paired-samples t-tests were further employed for intra-group comparisons. The normality of the quantitative variables was correspondingly assessed by the Kolmogorov-Smirnov test. The significance level of 0.05 was set for all the tests in this study.