Design and approach of the Living Organ Video Educated Donors (LOVED) program to promote living kidney donation in African Americans.
Sieverdes JC, Price M, et al.Contemporary Clinical Trials 2017; 04: 04.
Aims
To describe the rationale, methodology, design, and interventional approach of the Living Organ Video Educated Donors (LOVED) mobile health education program that aims to increase living donor kidney transplants (LDKTs) for African American end stage renal disease (ESRD) patients.
Interventions
The 5-year study is executed in three phases (the first two are complete) which include, a formative needs analysis using focus groups followed by program development (phase 1), a 1-arm proof of concept study using the LOVED program and subsequent refinement (phase 2), and a feasibility randomized controlled trial (RCT) comparing the LOVED program to standard care (phase 3).
Participants
60 African American adult ESRD patients were included in the Phase 3 RCT.
Outcomes
Primary outcomes assessed will be feasibility, indices of adherence, drop out and increases in knowledge, attitudes and self-efficacy. Secondary outcomes will include the percentage of patients who identify potential donors, those who elect to be screened, and who complete LDKT.
Follow-up
8 weeks and 6 months
CET Conclusions
This article presents the design and rational of the Living Organ Video Educated Donors (LOVED) programme which is designed to increase living donor kidney transplantation (LDKT) among African American renal failure patients. A needs assessment using focus groups and a 1-arm proof of concept study have been completed. A feasibility randomised controlled trial is currently ongoing in 60 renal failure patients (0-10 years on dialysis) comparing LOVED versus standard care. The sample size was intended to obtain estimates of variability for the primary outcomes and indicators of treatment effectiveness assuming a 10% drop out rate. Primary outcomes will be analysed using intention to treat analysis with missing data being imputed and include adherence and changes in LDKT knowledge, attitudes and self-efficacy from baseline to 6 months follow up. Secondary outcomes include the proportion of patients who identify potential donors, proportion of potential donors who complete screening and who donate a kidney. At the end of the RCT 15 LOVED group participants will participate in focus groups to obtain feedback to refine the programme so that it can be tested in a large, multicentre randomised controlled trial.
Quality notes
Quality assessment not appropriate
Trial registration
None