Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

NCT01233700 | Completed Phase 2

• 1 other identifier: R21NR011149
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Living Donation

Keywords

living donation; organ donation; psychological adaptation; mental health; physical well-being; interpersonal relations; quality of life; psychosocial factors

Outcome Measures

Primary Outcomes (8)

• 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

  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

  6 weeks post-donation

• interpersonal relationship quality and distress

  Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

  6 weeks post-donation

• quality of life

  RAND-12

  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

  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

  3 months post-donation

• interpersonal relationship quality and distress

  Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

  3 months post-donation

• quality of life

  RAND-12

  3 months post-donation

Secondary Outcomes (2)

• 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)

Study Arms (3)

Motivational Interviewing

EXPERIMENTAL

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

Enhanced Standard Care

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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

Interventions

Motivational Interviewing 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.

Motivational Interviewing

Healthy Lifestyles Education BEHAVIORAL

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

Enhanced Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 23924065 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mary Amanda Dew, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: November 3, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)