Living Donation
Conditions
Keywords
living donation, organ donation, psychological adaptation, mental health, physical well-being, interpersonal relations, quality of life, psychosocial factors
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.
Interventions
BEHAVIORALMotivational 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.
BEHAVIORALHealthy Lifestyles Education
Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
Sponsors
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| psychological distress | 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 | 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 | 6 weeks post-donation | Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales |
| quality of life | 6 weeks post-donation | RAND-12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with intervention | pre-donation (on average, 1 week post-intervention but before donation has occurred) | adapted Client Satisfaction Scale |
| Quality of decision to donate | pre-donation (on average, 1 week post-intervention but before donation has occurred) | Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items |
Countries
United States
Outcome results
None listed