Clinical trial NCT01233700: Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
Official title: Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Living Donation
Keywords: living donation
organ donation
psychological adaptation
mental health
physical well-being
interpersonal relations
quality of life
psychosocial factors
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2010-11-03
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: psychological distress
timeFrame: 6 weeks post-donation
measure: somatic/physical health perceptions
timeFrame: 6 weeks post-donation
measure: interpersonal relationship quality and distress
timeFrame: 6 weeks post-donation
measure: quality of life
timeFrame: 6 weeks post-donation
measure: psychological distress
timeFrame: 3 months post-donation
measure: somatic/physical health perceptions
timeFrame: 3 months post-donation
measure: interpersonal relationship quality and distress
timeFrame: 3 months post-donation
measure: quality of life
timeFrame: 3 months post-donation
Secondary outcomes:
measure: Satisfaction with intervention
timeFrame: pre-donation (on average, 1 week post-intervention but before donation has occurred)
measure: Quality of decision to donate
timeFrame: pre-donation (on average, 1 week post-intervention but before donation has occurred)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary Amanda Dew, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dew MA, DiMartini AF, DeVito Dabbs AJ, Zuckoff A, Tan HP, McNulty ML, Switzer GE, Fox KR, Greenhouse JB, Humar A. Preventive intervention for living donor psychosocial outcomes: feasibility and efficacy in a randomized controlled trial. Am J Transplant. 2013 Oct;13(10):2672-84. doi: 10.1111/ajt.12393. Epub 2013 Aug 7.