Nephrology · Medical Literature
Randomized Controlled Trial of a Digital Intervention (KidneyTIME) to Promote Live Donor Kidney Transplantation.
Abstract
Digital behavioral interventions are promising to support patients' pursuit of live donor kidney transplantation (LDKT). This study examined the effectiveness of a patient-led digital intervention (KidneyTIME) versus active control on facilitating LDKT. An individually randomized (1:1) parallel-group trial was conducted at a safety-net hospital transplant program with adult kidney transplant candidates in referral, evaluation, or listed phases who were English-speaking and had email or text access. KidneyTIME participants received animated video LDKT education and outreach enablement via video sharing. The primary outcome was ≥1 live donor inquiry within 12 months in the intent-to-treat population. Secondary outcomes included LDKT knowledge, attitudes, behaviors toward listing and donor outreach, extent of video sharing, and intervention acceptability assessed by survey at 4 timepoints post-exposure. Between 4/22 and 7/23, 422 candidates (mean age 54 years; 57% male, 45% income < $30,000) were randomized to KidneyTIME (n = 212) or active control (n = 210). Between-group differences in donor outreach behaviors and receipt of a donor inquiry were not detected. KidneyTIME participants had higher LDKT knowledge (p = 0.002), new listing behaviors (IRR:1.62, p = 0.005), and extent of video sharing (p = 0.016). In planned as-treated analysis, intervention participants who viewed at least one optional video had significantly higher cumulative donor inquiry probability than those who did not (viewer 22.9%; non-viewer 9.8%, p = 0.029). Intervention acceptability scores were high. A digital intervention self-administered by patients did not increase donor inquiries. Preliminary dose effect findings suggest the need to consider how to encourage people to engage more with the intervention.
Clinical relevance
Does a patient-led digital intervention (KidneyTIME), delivering animated video education and enabling peer video sharing, increase the rate of live donor kidney transplant (LDKT) inquiries compared to an active control among kidney transplant candidates at a safety-net hospital? __SNAPSHOT__ {"studyDesign":"Individually randomized (1:1), parallel-group, active-controlled trial (RCT); intent-to-treat primary analysis with a planned as-treated secondary analysis","setting":"Single safety-net hospital transplant program, Erie County Medical Center, Buffalo, New York, USA","sampleSize":"n = 422 (KidneyTIME: n = 212; active control: n = 210)","population":"Adult kidney transplant candidates in referral, evaluation, or waitlisted phases; English-speaking; with email or text access. Mean age 54 years; 57% male; 45% with annual income < $30,000. Enrolled April 2022 – July 2023.","intervention":"KidneyTIME: smartphone-optimized digital platform delivering animated video LDKT education with outreach enablement via patient-initiated video sharing to potential donors","comparator":"Active control (specific content not described in abstract)","primaryOutcome":"≥1 live donor inquiry received within 12 months, assessed in the intent-to-treat population","followUp":"12 months; surveys administered at 4 timepoints post-exposure","fundingSource":"Not reported in abstract"}
Key findings
In the intent-to-treat analysis, KidneyTIME did not significantly increase the primary outcome of ≥1 live donor inquiry within 12 months compared to active control; no between-group difference in donor outreach behaviors or receipt of a donor inquiry was detected (p-value and absolute rates not reported in the abstract). On pre-specified secondary outcomes, KidneyTIME participants demonstrated higher LDKT knowledge (p = 0.002), higher new listing behaviors (incidence rate ratio [IRR]: 1.62, p = 0.005), and greater extent of video sharing (p = 0.016). Intervention acceptability scores were described as high (specific scores not reported). In a planned as-treated analysis restricted to participants who viewed at least one optional video, cumulative donor inquiry probability was 22.9% versus 9.8% in non-viewers (p = 0.029; absolute risk difference: 13.1 percentage points [calculated]; NNT approximately 8 [calculated])—a finding interpreted by the authors as a preliminary dose-response signal rather than a definitive treatment effect. Adverse events were not reported in the abstract.
Practice implications
This RCT did not demonstrate that KidneyTIME increased live donor inquiries in the intent-to-treat population, which is the pre-specified, causally valid primary analysis. The intervention did improve surrogate endpoints—LDKT knowledge, listing behaviors, and video sharing—but these did not translate into the clinically meaningful outcome of actual donor contact. The as-treated dose-response finding (higher inquiry rates among those who engaged with optional video content) is hypothesis-generating only and subject to substantial selection bias, as participants who chose to view more content likely differ systematically from those who did not. Findings are most applicable to lower-income, English-speaking adult transplant candidates at urban safety-net institutions; non-English speakers, those without digital access, and patients at academic referral centers are not adequately represented. Only an abstract was available for this review; full methods, adjusted analyses, confidence intervals for the primary outcome, and subgroup data could not be evaluated. Practice should not change based on this trial alone. __LIMITATIONS__ 1. Single-center design at a safety-net hospital substantially limits generalizability to other transplant program types and patient populations. 2. The trial enrolled only English-speaking candidates with email or text access, excluding populations at highest risk for LDKT access disparities (non-English speakers, digitally excluded patients). 3. The primary ITT analysis was null; the as-treated dose-response analysis is subject to selection bias by indication (engagement confounding) and should be interpreted only as exploratory. 4. The active control intervention is not described in the abstract, precluding assessment of control arm intensity or contamination risk. 5. Absolute event rates and confidence intervals for the primary outcome are not reported in the abstract, limiting evaluation of statistical and clinical effect size. 6. Intervention acceptability data are self-reported and subject to social desirability bias. 7. Enrollment spanned only 15 months at a single site; baseline engagement rates and loss to follow-up are not reported in the abstract. 8. Funding source is not disclosed, and potential conflicts of interest cannot be assessed. 9. This summary is based on abstract data only; full-text evaluation may reveal additional methodological detail that alters interpretation. __BOTTOM_LINE_CATEGORY__ not_ready_for_clinical_application __BOTTOM_LINE__ KidneyTIME, a patient-led animated video and peer-sharing digital intervention, did not significantly increase live donor kidney transplant inquiries at 12 months in a safety-net hospital RCT (ITT analysis, n = 422). Although secondary outcomes of LDKT knowledge and listing behaviors improved, and a preliminary dose-response signal was observed among engaged users, these findings are insufficient to support adoption of this intervention as a strategy to increase LDKT rates. Further trials with higher engagement mechanisms, broader populations, and multi-center designs are needed before clinical implementation.