跳至主要内容
临床试验/NCT01233700
NCT01233700已完成2 期

Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
113
试验地点
2
主要终点
psychological distress

研究概览

简要总结

The purpose of this study is to evaluate the potential effectiveness of a psychosocial intervention based on the principles of motivational interviewing. The novel intervention will assist living donor candidates to think through any remaining concerns or questions that they may have about living donation. If the intervention is effective, it may help to prevent post-donation problems related to psychological and health outcomes.

详细描述

The protection of living donors' well-being and the prevention of any negative consequences of donation are among the foremost priorities in transplantation. Some donors experience poor psychosocial outcomes after donation, including psychological distress, poor perceived physical well-being, and strained family relationships. No preventive interventions have been mounted or tested for their ability to avert poor psychosocial outcomes in living donors. The present study will provide an initial test of a new intervention for this purpose. The new intervention utilizes motivational interviewing (MI) to address remaining concerns that individuals may have about proceeding with living donation. Study participants will be randomly assigned to either (a) participate in the MI intervention (during which they will be asked to answer a series of questions to help them better delineate their reasons for and against proceeding with living organ donation), (b) participate in a comparison intervention designed to inform them about healthy lifestyle habits, or (c) not receive any intervention. We plan to recruit a maximum of 150 adults who are considering whether to serve as living kidney or liver donors. We hypothesize that participants receiving the MI intervention will have superior outcomes (less psychological distress, fewer physical health complaints, better interpersonal relationships within their family, better overall quality of life)after donation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Score of 1 or greater on the Simmons Ambivalence Scale;
  • Must be able to speak English;
  • Have been evaluated as a potential living kidney or liver donor candidate;
  • Aged 18 or older

排除标准

  • 未提供

结局指标

主要结局

psychological distress

时间窗: 3 months post-donation

PRIME-MD depression and anxiety modules, BSI anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items

interpersonal relationship quality and distress

时间窗: 3 months post-donation

Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

somatic/physical health perceptions

时间窗: 3 months post-donation

Concerns About Donation Effects items, Simmons Post-donation Medical Concerns, Brief Pain Inventory short form, FACIT-fatigue scale, Post-surgery Body Image Questionnaire, Post-donation Symptom Checklist, Simmons Concerns About Future Health items, Simmons Perceived Stressfulness of Donation items

quality of life

时间窗: 3 months post-donation

RAND-12

次要结局

  • Satisfaction with intervention(pre-donation (on average, 1 week post-intervention but before donation has occurred))
  • Quality of decision to donate(pre-donation (on average, 1 week post-intervention but before donation has occurred))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Amanda Dew

Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验

Brief Intervention to Prevent Poor Psychosocial... | 临床试验