Healthy, Living Kidney Donation
Conditions
Keywords
Kidney donation, Telemedicine, Education, Counseling, Decision Making, Shared, Feasibility studies, Health Services Research, Care Delivery
Brief summary
The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are: * Is telemedicine a practical way to facilitate donor education and evaluation and counseling? * Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process? Researchers will compare standard care with a telemedicine care coordination approach. Participants will: \- Receive either standard care or telemedicine video visits to support shared decision making.
Detailed description
Living kidney donation provides a vital treatment option for patients with kidney failure, but many willing individuals face challenges in completing the donor evaluation and committing to donation. Donor education and counseling are essential for informed decision-making, yet these steps are often limited to in-person visits at transplant centers. This can create logistical challenges, delays, and variations in access to the living donor evaluation process. Telemedicine offers an opportunity to deliver a shared decision making approach to donor education and evaluation and counseling remotely, but its feasibility, acceptability, and impact have not been well studied. This pilot feasibility clinical trial is designed to test whether a telemedicine care coordination can support donor decision-making and engagement during the evaluation process for living kidney donation. Participants will be randomly assigned to one of two groups: * Standard Care Group (Control): A recorded video education session and an in-person donor evaluation and counseling with a nephrologist. * Telemedicine Group (Intervention): Two live telemedicine video sessions-one for education with a transplant provider and one for donor evaluation and counseling with a nephrologist. The findings from this feasibility trial will provide important information about the practicality and acceptability of telemedicine shared decision-making for living kidney donor candidates. Generated preliminary data will inform larger trials and ultimately guide transplant practice and policy to improve decision-making, efficiency, and access to living kidney donation.
Interventions
BEHAVIORALStandard Care (in control arm)
This Standard Care involves a recorded video education and in-person visit.
BEHAVIORALTelemedicine Shared Decision-Making
This intervention involves two live telemedicine video visits.
Sponsors
University of California, Irvine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Reside in the State of California * Registered living kidney donor candidate at UC Irvine Medical Center
Exclusion criteria
\- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 90 days | Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached. |
| Retention Rate | 90 days | Proportion of enrolled participants who remain in the study through the 90-day follow-up period, calculated as the number completing final follow-up divided by the number enrolled. |
| Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS) | 90 days | Decision conflict will be measured using the Decisional Conflict Scale (DCS), a 16-item validated instrument. Each item is scored from 0 (no conflict) to 100 (very high conflict), and a total score is calculated by averaging across items. Total scores therefore range from 0 to 100, with higher scores indicating worse decision conflict and greater uncertainty. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Donor Education and Evaluation and Counseling | 90 days | Completion of donor education and evaluation and counseling. Time to donor evaluation and counseling completion. |
| Intervention Acceptability | Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days | Participant-reported acceptability of the telemedicine intervention will be measured using the acceptability of intervention measure. This outcome will be assessed only in the Telemedicine Intervention Arm. |
Countries
United States
Contacts
CONTACTFawaz Al Ammary, MD PhD
CONTACTIvette Nunez, BS
PRINCIPAL_INVESTIGATORFawaz Al Ammary, MD PhD
University of California, Irvine
Outcome results
None listed