Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01233700
First received: October 26, 2010
Last updated: November 1, 2012
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Living Donation
Behavioral: Motivational Interviewing
Behavioral: Healthy Lifestyles Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • psychological distress [ Time Frame: 6 weeks post-donation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

  • quality of life [ Time Frame: 6 weeks post-donation ] [ Designated as safety issue: No ]
    RAND-12

  • psychological distress [ Time Frame: 3 months post-donation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 3 months post-donation ] [ Designated as safety issue: No ]
    Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

  • quality of life [ Time Frame: 3 months post-donation ] [ Designated as safety issue: No ]
    RAND-12


Secondary Outcome Measures:
  • Satisfaction with intervention [ Time Frame: pre-donation (on average, 1 week post-intervention but before donation has occurred) ] [ Designated as safety issue: No ]
    adapted Client Satisfaction Scale

  • Quality of decision to donate [ Time Frame: pre-donation (on average, 1 week post-intervention but before donation has occurred) ] [ Designated as safety issue: No ]
    Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Active Comparator: 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).
Behavioral: Healthy Lifestyles Education
Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
No Intervention: Standard Care
Subjects will receive the standard care and education provided by the Living Donor Program at their medical center.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233700

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mary Amanda Dew, Ph.D. University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233700     History of Changes
Other Study ID Numbers: R21-NR011149, R21NR011149
Study First Received: October 26, 2010
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
living donation
organ donation
psychological adaptation
mental health
physical well-being
interpersonal relations
quality of life
psychosocial factors

ClinicalTrials.gov processed this record on September 30, 2014