A Phase 2 interventional study of Motivational Interviewing and Healthy Lifestyles Education in Living Donation, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Prevention
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.
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.
University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Inclusion Criteria:
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.
Behavioral: Motivational Interviewing
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).
Behavioral: Healthy Lifestyles Education
Subjects will receive the standard care and education provided by the Living Donor Program at their medical center.
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.
Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
psychological distress
PRIME-MD depression and anxiety modules, Brief Symptom Inventory (BSI) anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items
Time frame: 6 weeks post-donation
somatic/physical health perceptions
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
Time frame: 6 weeks post-donation
interpersonal relationship quality and distress
Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
Time frame: 6 weeks post-donation
quality of life
RAND-12
Time frame: 6 weeks post-donation
psychological distress
PRIME-MD depression and anxiety modules, BSI anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items
Time frame: 3 months post-donation
somatic/physical health perceptions
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
Time frame: 3 months post-donation
interpersonal relationship quality and distress
Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
Time frame: 3 months post-donation
quality of life
RAND-12
Time frame: 3 months post-donation
Satisfaction with intervention
adapted Client Satisfaction Scale
Time frame: pre-donation (on average, 1 week post-intervention but before donation has occurred)
Quality of decision to donate
Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items
Time frame: pre-donation (on average, 1 week post-intervention but before donation has occurred)
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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