| Sumario: | Chronic kidney disease (CKD) is associated with substantial morbidity, mortality, and cost. CKD is associated with decreased patient quality of life (QOL) and increased caregiver burden. Peer mentoring (PM) improves activation of patients to participate in their own care and multiple outcomes in various chronic diseases. The effectiveness of a peer-led CKD intervention on patient QOL, patient activation, and caregiver burden has not been previously studied. OBJECTIVES: We conducted a randomized clinical trial to test the effectiveness of face-to-face (FTF) and online mentoring by trained peers, compared with usual care, on CKD patients' QOL, patient activation, and caregiver burden. METHODS: We randomly assigned 155 patients with CKD and 86 caregivers to receive 6 months of intervention in 1 of 3 groups: (1) FTF PM, (2) online PM, and (3) textbook-only group who received an informational textbook about CKD. Peer mentors were patients with stage 4 or 5 CKD, ≥18 years of age, or caregivers of patients with CKD, ≥18 years of age. Candidates for PM received formal training through 16 hours of instructional sessions facilitated by patients, caregivers, and health care professionals. Upon successful completion of the training, each PM candidate was designated a certified peer mentor. Participants in all 3 groups received a textbook that contains detailed information about kidney disease. Participants assigned to FTF intervention groups received 6 months of PM. Participants assigned to the online intervention group also received 6 months of PM through a secure password-protected interactive online platform. At baseline, 12 months, and 18 months, the patients completed the Kidney Disease Quality of Life-36 (KDQOL-36) instrument and the Patient Activation Measure (PAM) survey. Caregivers completed the Zarit Burden Interview (ZBI). The primary outcomes were (1) improvement in QOL and (2) decreased caregiver burden. The secondary outcome was improved patient activation as measured by PAM. The primary analyses were by intention to treat (ITT). We applied repeated-measures analysis of variance with a linear mixed-effects model to estimate time-related changes in outcome measures for each of the groups over the study period. We conducted exploratory analyses including interaction terms in the statistical models to investigate heterogeneity of treatment effects (HTEs). RESULTS: In our ITT analysis, we analyzed 52 patients in the FTF PM group, 52 patients in the online PM group, and 51 patients in the textbook-only group. Compared with baseline, online PM was associated with improved scores in Effects of Kidney Disease (EKD) (P = .01), Burden of Kidney Disease (BKD) (P = .01), Symptoms and Problems of Kidney Disease (P = .006), Short Form-12 (SF-12) Physical Composite Summary (PCS) (P = .001), and SF-12 Mental Composite Summary (MCS) (P = .0001). Compared with baseline, there were no statistically significant changes in KDQOL-36 domain scores in the FTF PM group and the textbook-only group. For employed participants, exploratory subgroup analyses showed larger effects of FTF PM on increased EKD (P = .002) and BKD (P = .04) scores, and larger effects of online PM on increased EKD score (P = .02), all relative to the study population as a whole. We found a positive effect of "not employed" status on the association between online PM and increased PCS score (P = .01). We also found a positive effect of male sex on the association between online PM and increased MCS score (P < .0001). Online PM was associated with increases in PAM score from baseline to 18 months (P = .0001). Compared with baseline, no statistically significant changes were found in PAM scores in the FTF group and the textbook-only group. Exploratory analyses showed that male (P < .0001) and married (P = .003) participants had larger effects of online PM on increased PAM scores. Female (P = .01) and not married (P = .03) participants had larger effects of FTF PM on increased PAM scores, all relative to the study population as a whole. In our ITT analysis, we analyzed 29 caregivers in the FTF PM group, 29 caregivers in the online PM group, and 28 caregivers In the textbook-only group. Compared with baseline, online PM was associated with a statistically significant decrease in the ZBI score (SE, −3.44; CI, −6.31 to −0.57; P = .002) with no HTE from any of the demographic variables. Compared with baseline, there were no statistically significant changes in ZBI score in the FTF group and the textbook-only group. CONCLUSIONS: Compared with baseline, online PM was associated with increased scores in 4 domains of the KDQOL-36 and PAM among patients with CKD. We detected HTE response for the effects of employment, sex, and marital status. Compared with baseline, online PM was associated with decreased burden of care among caregivers of patients with CKD. No statistically significant changes from baseline were found in domain scores of KDQOL-36, patient activation scores, or caregiver burden scores among the FTF PM and textbook-only groups. LIMITATIONS: The study was limited to English-speaking participants with computer literacy and internet access.
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