跳至主要内容
临床试验/NCT03599102
NCT03599102已完成不适用

Enhancing Kidney Donation Through Live Organ Video Educated Donors (LOVED) Study Phase

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Change in self-efficacy to ask others to be a living donor

研究概览

简要总结

LOVED stands for the Living Organ Video Educated Donors (LOVED) program. It is a culturally tailored program for African Americans to reduce the disparity of low rates of living kidney donation. It is a mobile health delivered platform that does not require transplant center visits, thus increasing the reach of the program compared to center-based program to enhance living kidney donation. The purpose of LOVED is to give education and encouragement to those who need a kidney transplant and teach about the process of living donation to be better educated when approaching others about donating a kidney. The ultimate goal of the program is to increase the number of living kidney donor transplants, especially among African Americans in South Carolina. The program was created to educate those in need of a kidney about the donor process, to dispel myths about living donation, discuss who can be asked to donate and develop and practice skills to start asking others for a living kidney donation. The program is designed to be completed using a tablet computer and is made up of weekly video education clips, resources, short quizzes to reinforce the learning points and weekly video chat sessions with others who need a kidney led by a "navigator" who was once a living donor kidney recipient. The video clips are made up of stories and brief educational messages from transplant center staff, physicians, former donors and recipients. The video chat sessions were designed to solve and address individual issues for those enrolled in the program and to give a sense of community as they continue on their journey to find a kidney. This randomized control trial uses groups of 6-9 participants in each LOVED group that lasts 8-weeks each. A total of 60 participants will be recruited with 30 assigned to LOVED and 30 assigned to a standard care groups. This program is funded by a grant from the National Institute of Health and was developed at the Medical University of South Carolina.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years old
  • African American
  • Legally competent
  • Able to read and speak in English
  • Able to use tablet computers (after instruction)
  • Able to use cell phone
  • 5 years or less on the kidney waitlist with active status including pre-emptive and ESRD patients on dialysis
  • 10 years or less on dialysis

排除标准

  • Patients who have currently identified PDs moving through the evaluation stage

结局指标

主要结局

Change in self-efficacy to ask others to be a living donor

时间窗: Change between 0 and 8 weeks and change between 0 and 6 months

Willingness to Discuss LDKT Scale (i.e., measuring self-efficacy (SE)) (1 item each for family, friends, and strangers7 pt. Likert scale) 1-7 range with higher values representing higher SE to approach others about living donation

Change in knowledge about living donation

时间窗: Change between 0 and 8 weeks and change between 0 and 6 months

Score measures for self-efficacy, knowledge and attitudes to approach others to be a living donor -LDKT Knowledge Scale (knowledge) (15 item T/F); each correct response adds 1 point. 0-15 range with higher numbers represent higher knowledge.

Participant adherence to study protocols

时间窗: Assessed at 8 weeks

Tolerability as defined by % retention to study (% of participants who self-remove from the study) Fidelity as defined by %adherence to chat sessions and completion %of video modules.

Change in attitudes on living donation

时间窗: Change between 0 and 8 weeks and change between 0 and 6 months

LDKT Concerns Scale (i.e., measuring attitudes) (21 T/F with one point for each statement suggestive of more worry); 0-21 range with higher results representing more concerns about LDKT.

次要结局

  • Completing living donor kidney transplantation(8 weeks, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验