Methods: Study participants were patients receiving hemodialysis on an outpatient basis for end stage renal failure at Clinic B in City A. The intervention period was 6 months starting in June 2011. Prior to intervention, five institutions in City A were asked to participate in the study, and written permissions were obtained from three institutions that gave consent to participate. Participant selection criteria were: 1) receiving hemodialysis on an outpatient basis, 2) hemodialysis experience of at least 4 months, 3) systemically stable physical condition, 4) percentage increase in body weight of at least 5% measured every 2 days, 5) serum potassium of at least 5.1 mEq/l with regular tests, 6) reliably functioning vascular access, 7) mentally and emotionally stable, and 8) ability to complete the questionnaire by himself/herself. For 4) and 5), patients who satisfied one of the criteria and met the criteria at least twice during the 3 months before intervention were included. Nursing managers at the institutions were asked to refer potential participants, and their eligibility was determined by the principal investigator based on conversations with participants and on their medical records. Participants who consented to participate in the study were randomly allocated to two groups using an envelope. 1) The nursing manager placed the necessary number of sheets of paper of two types, A and B, for the number of people into a single envelope. 2) The nursing manager played the role of subjects, and drew one sheet of paper from the envelope, 3) Participants were allocated by a draw. For the intervention group, an educational approach system, where 2DM developed by Moriyama was modified and elements necessary for health management as keywords were created into cards, was combined with chronic maintenance dialysis patient outpatient medical management. For the control group, chronic maintenance of dialysis patients during outpatient medical management was performed. A randomized controlled study was conducted with two time points, before and after intervention/follow-up. The study received ethical approval from C University Research Ethics Committee. Patients in the control group who were interested in the educational approach system were provided information after the study. The principal investigator explained to subjects at the time of obtaining consent for this study that patients in the control group who were interested in the educational approach system could also undergo the system after the study. The Kidney Disease Quality of Life Short Form (KDQOL-SF) was used as a scale for measuring QOL. The following information on patient attributes and laboratory values were taken from medical records: age, sex, primary disease, number of years on hemodialysis, urea nitrogen, creatinine, serum potassium level, serum phosphorus level, serum calcium level, hematocrit, hemoglobin, and percentage weight gain. Cards obtained in 2DM were used to evaluate statuses of recognizing emotions related to health management. For statistical analysis, paired t-test was used to compare the two groups before and after intervention and one-way ANOVA with repeated measures was used to evaluate the process of recognizing emotions related to health management in the intervention group. JMPR11 was used for analysis and p<0.05 was considered statistically significant.
Results: Two participants in the intervention group (n=15) were lost to follow-up due to relocation and four participants in the control group (n=15) were lost to follow-up due to hospitalization (n=3) and relocation (n=1). This resulted in 13 patients in the intervention group and 10 patients in the control group for analysis. Baseline attributes of the participants showed no difference between the two groups. Modulation in serum phosphorus levels was significantly different between the two groups and was significantly lower in the intervention group compared to the control group (t (21)=2.236, p=0.036, effect size r=0.44). Additionally, QOL had a significantly greater increase in the intervention group compared to the control group (t (21)=-2.567, p=0.018, effect size r=0.49). The recognition status of emotions related to health management that showed significant score differences were: “leisure activities” (p=0.013), “vegetables” (p=0.032), “fruits” (p=0.042), “amount of water” (p=0.010) cards. Specifically, “leisure activities” had a higher score 6 months later compared to baseline, and “vegetables,” “fruits,” and “amount of water” had higher scores 3 months later compared to baseline. No adverse events were observed.
Conclusion: Intervention through an educational approach system demonstrated a clear effect on laboratory values of serum phosphorus and QOL. Furthermore, labels used in 2DM indicated the process of changing from a negative emotion to a positive one. These findings suggested that the educational approach system with 2DM can monitor health management motivation and action transformation process and can also maintain and improve QOL in hemodialysis patients.