The study is a 2-arm randomized controlled trial among patients referred for kidney transplant evaluation at a single transplant center to compare the effects of a digital-analog intervention to increase living-donor kidney transplant access (KidneyTIME+) with or without human guide . Following consent and baseline assessment, participants are randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide.
referred to the transplant center for a kidney transplant
aged 18 years and older
speaks English
Previously exposed to any component of the intervention
Listed for a kidney transplant at another center (multilisted)
Seeking multiorgan transplantation
Parallel
Digital education outreach intervention for kidney transplant access and human guide
BehavioralReceives (1) donor search materials, (2) electronic resource access messages, (3) practical assistance to use the intervention and empower taking the outreach action and (4) telephonic human guide
Digital education outreach intervention for kidney transplant access only (unguided)
BehavioralReceives (1) donor search materials, (2) electronic resource access messages, and (3) practical assistance to use the intervention and empower taking the outreach action.
Living donor inquiry
Count of living donor inquires to the transplant center on behalf of the study participants within 6 months from enrollment. Each inquiry (telephone call, email, letter) is counted and added to a discrete field for all patients in the electronic medical record.
LDKT Perceived understanding
Developed specifically for this study as a measure of perceived understanding about LDKT as delivered in the intervention condition. In this 4 item 4-point Likert questionnaire, total scores range from 4-16 with higher scores indicating greater LDKT-related understanding. The scale captures different dimensions of understanding including kidney transplant navigation, awareness of services, and donor outreach.
LDKT Conversational self-efficacy
A 2-item survey testing confidence to communicate about LDKT with others. Items are rated on a scale of 1 to 4, total scores range from 2-8. Higher scores indicate greater confidence to communicate about LDKT with others.
LDKT Beliefs scale
Developed specifically for this study as a measure of patients' beliefs about LDKT. Questions were drawn from existing measures in the literature. We created a 2-item scale. One item captured the degree to which a person believes that LDKT is an advantage. The other item assessed the degree to which a person believes their social network is healthy enough to donate a kidney. Items are rated on a scale of 1 to 4. Total scores range from 2-8 with higher scores indicate greater concerns about live kidney donation.
Donor outreach behaviors
A measure of ongoing outreach toward living donor kidney transplantation. To assess LDKT action behaviors patients will be asked whether they had done any of 14 related behaviors adapted from existing measures in the literature. Patients who indicated they had done the action will be counted and scores will range from 0 to 14. Higher scores indicate more outreach.
Time to waiting-list placement
The first time from evaluation to active placement on the kidney transplant waiting list will be assessed via medical record review.
Intervention Acceptability
16-item survey assessing intervention usage, ease of use, and usefulness. Each question has 4 Likert-scale options bounded by strongly agree and strongly disagree or multiple responses specific to the question. Total scores range from 16-64 with higher scores indicate greater intervention acceptability.
Patient perception of donor offer
A one item question asking participants if someone has agreed to donate a kidney to them, with the options of answering 'yes', 'no', or 'maybe'.
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This trial is not recruiting at the moment. You can still explore other options:
