Discussion
ESKD, intradialytic weight gain, depressive symptoms, depression, diabetes
CHRONIC ILLNESSES, COMPLICATIONS, DIABETES
In this pilot trial we tested the feasibility of implementing a behavioral-education intervention for patients on HD, and the effect of our intervention on QOL and self-care. We were only able to complete the study in 29 participants despite assessing 259 patients for eligibility. For participants that did complete the study, there was a positive impression of the intervention. Participants liked that it was delivered during the HD session and its focus on quality of life. Our intervention did not lead to any significant change in KDQOL-36 PCS or MCS scores over the 16-week study period. The intervention also did not lead to significant changes in self-care markers compared to control.Two of the themes that emerged from qualitative interviews were: the convenience of delivering the intervention during hemodialysis and the novel content of the intervention. Participants were engaged with sessions because they had few competing demands during dialysis. Occasionally, however, they were too tired to participate. Participants also liked the behavioral content of the intervention. They felt that it focused on topics not traditionally covered by social workers, including how dialysis affects their personal lives. They also liked that the homework reinforced behavioral techniques.Recommendations for adapting the intervention emerged from qualitative interviews. One social worker felt there were too many self-care recommendations delivered over the 8 sessions. She suggested focusing on a few topics. Physicians noted the difficulty in retaining social workers to deliver the intervention and recommended that other health care providers be trained to deliver the intervention. They felt that being engaged with patients and being dedicated to delivering the intervention without other responsibilities were the only requirements necessary.Two prior randomized controlled trials (RCT) of CB interventions in patients on dialysis with depression successfully improved depressive symptoms, QOL, and self-care (intradialytic weight gain) (10, 11). Both interventions were delivered by a psychologist. One delivered individual CBT during the HD session, while the other delivered group CBT at a time when participants were off dialysis. To our knowledge there is only one prior study of a behavioral intervention that targeted all dialysis patients regardless of the presence of depression and that targeted improvements in QOL and self-care [There are differences between our intervention and the aforementioned study. Unlike the prior study, we chose to do the intervention individually and chair-side during dialysis. Although this was done to optimize adherence to sessions and prevent drop-out, it may have prevented beneficial group interactions. Additionally, instead of using a psychologist, we trained a dialysis social work to deliver the intervention. A similar technique has been used successfully in other chronic illnesses. In a randomized trial of 222 patients with poorly controlled diabetes with minimal complications, a group-based behavioral-education, delivered by nurse and dietician educators trained to deliver CB strategies, significantly improved HbA1c compared to control arms without these strategies [We suggest two major changes for future studies of our intervention. The first would be to choose a nurse, nutritionist, or dialysis technician that has been certified in ESKD education, without other conflicting responsibilities, and that has been trained in delivering CB strategies, to deliver the intervention. This would allow a larger group of people to deliver the intervention. The second change would be to narrow the scope of the sessions to focus on only a few aspects of self-care.The strength of this study lies in its simplicity and its potential to be immediately implemented in US HD units. It is brief and performed during the HD session by dialysis social workers. Additionally, the slides, worksheets and handouts are readily available.The study had several limitations. There was turnover in the social workers performing the intervention and this delayed the time from randomization to the first intervention session, leading to unequal drop-out among groups and limiting our results. As a pilot study, we analyzed only data from subjects that completed at least one intervention or control session. This likely introduced bias but enabled us to get more data about the effectiveness of the intervention. Additionally, we were not able to record intervention sessions due to constraints placed by the dialysis units and dialysis clinical social workers only received 6-hours of training in CB-strategies potentially limiting the behavioral interventions performed with participants. Finally, the study was underpowered. The original power analysis determined that 40 participants were needed to detect clinically relevant changes in HrQOL (8-point change in PCS), and, due to participant and social worker drop-out, only 34 participants were analyzed. There is, however, important data regarding the feasibility of the intervention that can be used for future studies.