Living DonationPhase 2NCT01233700
Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
A Phase 2 study testing Motivational Interviewing and Healthy Lifestyles Education in people with Living Donation, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Living Donation
- What is being tested?
- Motivational Interviewing and Healthy Lifestyles Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Living Donation
- Being tested
- Motivational Interviewing, Healthy Lifestyles Education
- Keywords
- living donation, organ donation, psychological adaptation, mental health, physical well-being, interpersonal relations, quality of life, psychosocial factors
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Healthy Lifestyles EducationBehavioural
Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 weeks post-donation
interpersonal relationship quality and distress
Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
Measured: 6 weeks post-donation
quality of life
RAND-12
Measured: 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
Measured: 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
Measured: 3 months post-donation
interpersonal relationship quality and distress
Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
Measured: 3 months post-donation
quality of life
RAND-12
Measured: 3 months post-donation
Secondary outcomes (2)
Satisfaction with intervention
adapted Client Satisfaction Scale
Measured: 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
Measured: pre-donation (on average, 1 week post-intervention but before donation has occurred)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Living DonationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Mary Amanda Dew, University of Pittsburgh
- Investigators
- Mary Amanda Dew, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233700
- Sponsor's protocol ID
- R21NR011149
- Other IDs
- R21NR011149
- Status last verified
- Feb 2022
- First submitted
- 26 Oct 2010
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23924065
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
- ClinicalTrials.gov ID
- NCT01233700
- Acronym / sponsor ID
- R21NR011149
- Conditions
- Living Donation
- Keywords
- living donation, organ donation, psychological adaptation, mental health, physical well-being, interpersonal relations, quality of life, psychosocial factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingSubjects 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. |
| Enhanced Standard Care | Active comparator | Behavioral: Healthy Lifestyles EducationSubjects 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). |
| Standard Care | No intervention | –Subjects will receive the standard care and education provided by the Living Donor Program at their medical center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingStandard 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. | Behavioural | Motivational Interviewing |
| Healthy Lifestyles EducationEducational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors. | Behavioural | Enhanced Standard Care |
Primary outcome
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
2 secondary outcomes
Satisfaction with intervention
Time frame: pre-donation (on average, 1 week post-intervention but before donation has occurred)
Quality of decision to donate
Time frame: pre-donation (on average, 1 week post-intervention but before donation has occurred)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 23924065Dew 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Amanda Dew, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Interviewing and Healthy Lifestyles Education in people with Living Donation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological distress (time frame: 6 weeks post-donation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01233700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.