Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Living Donation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Motivational Interviewing

Subjects will receive two, individual telephone sessions with an interventionist, each lasting approximately 30-45 minutes. The sessions will focus on assisting subjects to delineate their reasons for or against proceeding with living organ donation and assisting subjects to resolve any lingering concerns about their decisions regarding donation.

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

Standard motivational interviewing techniques will be applied to assist subjects to consider and work to resolve any remaining concerns, doubts, or ambivalence about their decision about donating an organ to someone else.

Enhanced Standard Care

Subjects will receive two individual telephone sessions with an interventionist, each lasting approximately 30-45 minutes. The sessions will focus on providing educational information to subjects regarding healthy lifestyle issues (healthy eating, diet, exercise, quitting smoking).

Group Type ACTIVE_COMPARATOR

Healthy Lifestyles Education

Intervention Type BEHAVIORAL

Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.

Standard Care

Subjects will receive the standard care and education provided by the Living Donor Program at their medical center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational Interviewing

Standard motivational interviewing techniques will be applied to assist subjects to consider and work to resolve any remaining concerns, doubts, or ambivalence about their decision about donating an organ to someone else.

Intervention Type BEHAVIORAL

Healthy Lifestyles Education

Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No