Chronic Kidney Diseases, End-stage Renal Disease
Conditions
Keywords
Kidney transplant access, living kidney donation, education, web-based intervention, randomized controlled trial
Brief summary
The study is a- 2-arm randomized controlled trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up. Following consent and baseline assessment, participants were randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care.
Detailed description
Over a 2.5 year period we will conduct a 2-arm parallel randomized trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of KidneyTIME versus usual care for KTX access over 12 months of intervention use and follow-up. Participants will be recruited from the Transplant program at Erie County Medical Center, a safety-net hospital in Buffalo, New York. Each week, electronic records will be accessed to identify potential participants who had been referred to the transplant center for a kidney transplant, are aged 18 years and older, speak English, have internet access, and signed electronic consent as well as provided a text or email address. We will excude patients previously exposed to any component of the intervention. Each potential participant will be sent an electronic invitation from the principal investigator (a transplant surgeon). This message will briefly described the study and include a personal link to an online consent form describing study procedures and potential risks. A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan. The entire study and the progress tracker will be hosted on Alchemer. Those who sign electronic consent to participate will be automatically guided to a baseline sociodemographic survey (T0). Upon completion, computer-generated randomization will stratify participants by self-reported race (Black versus Other), with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment one they access the study educational content. KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. All components of the intervention were developed through a user-centered design approach by involving kidney failure patients and social network members, to improve usability and increase the likelihood of adoption. In the intervention arm, we chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. The first video sets the stage for the intervention and introduces the viewer to an overview of LDKT. The next 5 videos address common misconceptions about live kidney donation: Video 1: LDKT introduction, Video 2: Donor eligibility, Video 3: Donor evaluation, Video 4: Kidney paired donation, Video 5: Donation Costs, Video 6: Donor lifestyle. After completing the proscribed videos and an immediate-post exposure survey, everyone then receives a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website can be accessed using this link from any electronic device throughout the study. Website use will be prompted by automated messages (email or SMS) that introduced videos that may interest users, provided the website link, and encouraged video viewing and sharing. Messages will be personalized with their name and provide researchers contact information. Prompts will be sent monthly for 12 months. Control participants will receive the transplant program's 13-minute usual care video, a nurse-narrated power-point-based video outlining recipient evaluation, surgery, recovery processes and outcomes while highlighting the option of LDKT. This condition was active since it intended to aid kidney transplant access. It was utilized to offer participants education with perceived benefit and encourage further study participation. All participants routinely receive educational materials from non-study sources through usual Transplant Center protocols including written materials, nurse communications, and the usual care video shown on a clinic computer during transplant evaluation. Therefore control participants viewed the usual care video twice. After completing the proscribed video education, all participants will be invited to fill out serial surveys immediately (T1) and 1 month (T2), 6 months (T3), and 12-months (T4) post-baseline. Participants will receive up to 6 reminders (5 automatic and 1 personalized) to complete surveys. At study conclusion, intervention participants will be invited to an exit interview and controls will be offered access to the intervention website. All participants will receive up to $125 for completing study milestones (4 surveys and an exit interview).
Interventions
Same as arm description
Sponsors
Study design
Intervention model description
Parallel randomized controlled trial
Eligibility
Inclusion criteria
* referred to the transplant center for a kidney transplant * aged 18 years and older * speaks English * has access to the internet
Exclusion criteria
* Previously exposed to any component of the intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Living Donor Inquiry | 12 months | Living donor inquiry to the transplant center on behalf of the participant by telephone, email, or mail within 12 months from enrollment. Each inquiry is captured for all patients as a discrete field in the electronic medical record within 12 months from enrollment. An inquiry includes any request for information or evaluation to be a living kidney donor in which the recipients' name is specified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Living Donor Kidney Transplant Knowledge | Immediately post baseline, 1 month, 6 month, and 12 months | Developed specifically for this study as a measure of patients' knowledge about LDKT as delivered in the intervention condition. In this 12-item true-false questionnaire, total scores range from 0-12 with higher scores indicating greater LDKT-related knowledge. The scale captured different dimensions of knowledge including donor eligibility criteria, clinical outcomes, costs of the donation procedure, donor diet and medications, donor priority for transplant, and kidney paired donation. |
| Living Donor Kidney Transplant Concerns | Immediately post baseline, 1 month, 6 month, and 12 months | Developed specifically for this study as a measure of patients' concerns about LDKT. Questions were drawn from existing measures in the literature. We created a 6-item scale that captured concerns about LDKT including donation costs, evaluation process, function with a single kidney, poor outcome, and surgical risk as well as one question about access to deceased-donor kidney transplantation. Items are rated on a scale of 1 to 4, with the total score range 6 - 24. Higher scores indicate greater concerns about live kidney donation (a worse outcome). |
| Living Donor Kidney Transplant Readiness | Immediately post baseline, 1 month, 6 month, and 12 months | A measure of one's readiness for living-donor kidney transplantation. This 1-item scale measures the degree to which a person is ready for LDKT and is adapted from existing measures in the literature. Response options correspond to 5 stages of change based on the Transtheoretical Model and Stages of Change and are rated on a scale of 1 to 5 (minimum total value 1 and maximum total value 5) with higher scores indicating greater readiness (a better outcome). |
| Number of Participants With at Least One New Living Donor Kidney Transplant Access Behavior | Immediately post baseline, 1 month, 6 month, and 12 months | A measure to assess LDKT access behaviors. Patients were asked if they had done any of 5 transplant-related behaviors adapted from existing measures in the literature at baseline and at 1, 6, and 12 months. Statistical comparisons are based on Fisher's exact test. Proportions indicate at least one new behavior enacted after baseline. |
Countries
United States
Contacts
University at Buffalo
Participant flow
Recruitment details
Participants were recruited between April 2022 and July 2023 from the transplant program, located in a safety-net hospital in Buffalo, New York. Each week, electronic records identified English-speaking adults (18 years and older) referred to the center for kidney transplantation, including those with a scheduled appointment to be evaluated, undergoing evaluation, or already waitlisted for a transplant. Patients were excluded for prior exposure to any LDKT access intervention and lack of access.
Pre-assignment details
Upon completion, simple computer-generated randomization stratified participants, by self-reported race (Black or African-American vs other), with equal allocation to 2 treatment arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Active Facebook account Has active Facebook account | 163 Participants |
| Active Facebook account No active Facebook account | 47 Participants |
| Age, Customized Age 50-60 years | 141 Participants |
| Age, Customized Age < 50 years | 64 Participants |
| Age, Customized Age > 60 years | 80 Participants |
| Basic Social Support Basic Social Support (≥25th percentile) | 159 Participants |
| Basic Social Support Low Basic Social Support (<25th percentile) | 51 Participants |
| Chronic dialysis treatment No chronic dialysis treatment | 49 Participants |
| Chronic dialysis treatment Requires chronic dialysis treatment | 155 Participants |
| Education College degree | 82 Participants |
| Education No college degree | 128 Participants |
| Employment status Employed | 42 Participants |
| Employment status Not employed | 159 Participants |
| Enrollment method Enrolled using email | 274 Participants |
| Enrollment method Enrolled using text | 72 Participants |
| EPTS at evaluation EPTS at evaluation ≤ 70% | 163 Participants |
| EPTS at evaluation EPTS at evaluation > 70% | 47 Participants |
| Evaluation phase at study entry Post-evaluation phase at study entry | 104 Participants |
| Evaluation phase at study entry Pre-evaluation phase at study entry | 108 Participants |
| Has working computer Does not have working computer | 7 Participants |
| Has working computer Has working computer | 203 Participants |
| Health Literacy Health Literacy (≥25th percentile) | 320 Participants |
| Health Literacy Low Health Literacy (<25th percentile) | 102 Participants |
| Household - adults Living with other adult | 308 Participants |
| Household - adults Single adult household | 114 Participants |
| Insurance type Medicaid, state, or veterans insurance | 109 Participants |
| Insurance type No medicaid, state, or veterans insurance | 209 Participants |
| Kidney transplants No prior kidney transplant | 180 Participants |
| Kidney transplants Prior kidney transplant | 51 Participants |
| Number of close friends or relatives Number of close friends or relatives <4 | 206 Participants |
| Number of close friends or relatives Number of close friends or relatives 4+ | 216 Participants |
| Race/Ethnicity, Customized Black or African American, non-Hispanic | 77 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants |
| Race/Ethnicity, Customized Other | 18 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 113 Participants |
| Sex: Female, Male Female | 181 Participants |
| Sex: Female, Male Male | 241 Participants |
| Social media use Does not use social media | 51 Participants |
| Social media use Uses social media | 331 Participants |
| Total annual household income Prefer not to answer | 55 Participants |
| Total annual household income Total annual household income ≤ $30,000 | 85 Participants |
| Total annual household income Total annual household income $30,001-50,000 | 38 Participants |
| Total annual household income Total annual household income > $50,000 | 55 Participants |
| Watches videos online Does not watch videos online | 50 Participants |
| Watches videos online Watches videos online | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 212 | 6 / 210 |
| other Total, other adverse events | 0 / 212 | 0 / 210 |
| serious Total, serious adverse events | 0 / 212 | 0 / 210 |