Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- interpersonal relationship quality and distress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Motivational Interviewing (Behavioral)
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).
Intervention: Healthy Lifestyles Education (Behavioral)
Standard Care
Subjects will receive the standard care and education provided by the Living Donor Program at their medical center.
Outcomes
Primary Outcomes
interpersonal relationship quality and distress
Time Frame: 3 months post-donation
Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
psychological distress
Time Frame: 3 months post-donation
PRIME-MD depression and anxiety modules, BSI anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items
somatic/physical health perceptions
Time Frame: 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
Time Frame: 3 months post-donation
RAND-12
psychological distress
Time Frame: 6 weeks post-donation
PRIME-MD depression and anxiety modules, Brief Symptom Inventory (BSI) anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items
somatic/physical health perceptions
Time Frame: 6 weeks 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
interpersonal relationship quality and distress
Time Frame: 6 weeks post-donation
Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
quality of life
Time Frame: 6 weeks post-donation
RAND-12
Secondary Outcomes
- 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))
Investigators
Mary Amanda Dew
Professor
University of Pittsburgh