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Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

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ClinicalTrials.gov Identifier: NCT01233700
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Pittsburgh

October 26, 2010
November 3, 2010
December 3, 2014
March 2010
April 2013   (Final data collection date for primary outcome measure)
  • 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
  • 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
  • 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
  • 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, 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 ]
    SF-12
  • 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
  • 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
  • quality of life [ Time Frame: 3 months post-donation ]
    SF-12
Complete list of historical versions of study NCT01233700 on ClinicalTrials.gov Archive Site
  • Satisfaction with intervention [ Time Frame: pre-donation (on average, 1 week post-intervention but before donation has occurred) ]
    adapted Client Satisfaction Scale
  • Quality of decision to donate [ Time Frame: pre-donation (on average, 1 week post-intervention but before donation has occurred) ]
    Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items
Same as current
Not Provided
Not Provided
 
Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Living 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.
  • Behavioral: Healthy Lifestyles Education
    Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
  • 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.
    Intervention: Behavioral: Motivational Interviewing
  • 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).
    Intervention: Behavioral: Healthy Lifestyles Education
  • No Intervention: Standard Care
    Subjects will receive the standard care and education provided by the Living Donor Program at their medical center.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
150
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01233700
R21NR011149( U.S. NIH Grant/Contract )
R21NR011149 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
National Institute of Nursing Research (NINR)
Principal Investigator: Mary Amanda Dew, Ph.D. University of Pittsburgh
University of Pittsburgh
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP