End-stage Renal DiseaseNCT05255757
Network Interventions to Reduce Disparities in Living Kidney Donation
A study testing Script Intervention and Search Intervention in people with End-stage Renal Disease, run by Penn State University at 2 sites in United States.
Trial summary
For this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Script Intervention and Search Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2021to 31 May 2024
- Phase
- Interventional
- 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
- Are KT candidates at the University of Pennsylvania or University of Alabama-Birmingham OR were identified by KT candidate from the University of Pennsylvania or University of Alabama-Birmingham as a network member
- Are adults aged 18 or older
- Are able and willing to consent to participation in the survey
Who cannot join
- Person is not a KT candidate at University of Pennsylvania or University of Alabama-Birmingham OR was NOT identified by KT candidate from University of Pennsylvania or University of Alabama-Birmingham as a network member
- Individuals who are not yet 18
- Participant does not speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama-Birmingham
Birmingham, Alabama, 35233
Penn Medicine-- University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Social Network Interventions to Reduce Race Disparities in Living Kidney Donation
For this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. This project will examine how network characteristics are associated with eventual living donor kidney transplant outcomes and test the efficacy of evidence-based interventions designed to assist kidney transplant candidates in participant donor search on a multi-center scale.
Read the detailed description
The overall goal is to understand the process and assist participants who do not receive unsolicited offers to be evaluated as a living kidney donor in initiating and effectively conducting these critical conversations with participants kin and friends. In the search intervention, based on what they can tell investigators about the number, type, perceived health, perceived relationship, and potential willingness to donate, as well as analyses of data from the National Health and Nutrition Examination Survey (NHANES) investigators will counsel them on which members of participants family and friendship networks appear most biomedically promising as donors among the subset of these individuals that participants have not ruled out for known medical or perceived relationship reasons. In the rhetorical intervention, investigators will test non-coercive, promising verbal scripts that have proven promising in preliminary tests in vignette experiments in online and phone surveys.
AIM 1: Survey transplant candidates about their social network and transplant-related attitudes, knowledge, and characteristics; and randomize participants into one of two interventions or a control group.
AIM 2: Send network member participants a survey that measures potential donor attributes that are hypothesized to influence donation decisions, such as medical contraindications, blood type, health insurance status, and barriers to living donation.
AIM 3: Test whether participant social networks and interventions affect donation outcomes using medical records and follow-ups provided by Penn and UAB. Investigators will create the first predictive model of potential donor evaluation and actual donation. This information is critical to improve clinical practice and efforts to ethically influence the living donor search process.
- Conditions
- End-stage Renal Disease
- Being tested
- Script Intervention, Search Intervention
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Script InterventionBehavioural
This intervention provides language to participants to allow them to discuss kidney transplantation with their social network.
Search InterventionBehavioural
This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | This group will only complete study survey and refer members of their family and social network for participation in a web survey. |
| Script Intervention | Experimental | This group will complete the survey, refer members of their family and social network for participation in a web survey, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. Receives: Behavioral: Script Intervention |
| Search Intervention | Experimental | This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. Receives: Behavioral: Search Intervention |
| Both Search and Script Intervention | Experimental | This group will complete the candidate survey, refer members of their family and social network for participation in a web survey, be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. Receives: Behavioral: Script Intervention; Behavioral: Search Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Received a living donor kidney transplant
Living donor kidney transplant received by patient
Measured: up to 3 years
Received a deceased donor kidney transplant
Deceased donor kidney transplant received by patient
Measured: up to 3 years
Death
Patient died during the follow-up period
Measured: up to 3 years
Completed living kidney donor screening questionnaires
Number of completed living kidney donation screening questionnaires completed for patient
Measured: up to 3 years
Preliminary approval from living kidney donor screening questionnaires
Number of completed living kidney donor screening that received preliminary approval for patient
Measured: up to 3 years
Completed living kidney donor evaluations
Number of living kidney donor evaluations completed for patient
Measured: up to 3 years
Approvals for living kidney donor candidacy
Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient
Measured: up to 3 years
Secondary outcomes (6)
Preference for living kidney donor
A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding preference for living kidney donor
Measured: Immediate
Concerns about living kidney donation
A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding concerns for living kidney donation
Measured: Immediate
Living donor kidney transplant willingness
A set of survey questions asked both before and after the intervention, to assess intermediate attitude outcomes regarding living donor kidney transplant willingness
Measured: Immediate
Self-rated kidney transplant knowledge
Respondent is asked to rate their level of knowledge related to kidney transplantation.
Measured: Immediate
Trust in medical institutions
Respondent is asked to rate their trust in medical institutions.
Measured: Immediate
Religious views' effect on kidney transplant willingness
Respondent is asked how strongly they agree that their religious views affect their willingness to pursue a kidney transplant.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start12 Oct 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- There are two interventions randomly assigned to participants in a factorial experimental design. The first intervention is the search intervention. In addition to the candidate survey, transplant candidates assigned to this intervention will be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. The second intervention is the script intervention, where in addition to the survey, transplant candidates will review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. 25% of participants will be assigned to each of the following factorial experimental groups: no intervention, search intervention only, script intervention only, or both search and script intervention.
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Daw, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255757
- Sponsor's protocol ID
- 849197
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Interventions to Reduce Race Disparities in Living Kidney Donation
- ClinicalTrials.gov ID
- NCT05255757
- Acronym / sponsor ID
- 849197
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of Alabama at Birmingham
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Feb 2022 (actual)
- 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.
For this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. This project will examine how network characteristics are associated with eventual living donor kidney transplant outcomes and test the efficacy of evidence-based interventions designed to assist kidney transplant candidates in participant donor search on a multi-center scale.
Detailed description
The overall goal is to understand the process and assist participants who do not receive unsolicited offers to be evaluated as a living kidney donor in initiating and effectively conducting these critical conversations with participants kin and friends. In the search intervention, based on what they can tell investigators about the number, type, perceived health, perceived relationship, and potential willingness to donate, as well as analyses of data from the National Health and Nutrition Examination Survey (NHANES) investigators will counsel them on which members of participants family and friendship networks appear most biomedically promising as donors among the subset of these individuals that participants have not ruled out for known medical or perceived relationship reasons. In the rhetorical intervention, investigators will test non-coercive, promising verbal scripts that have proven promising in preliminary tests in vignette experiments in online and phone surveys.
AIM 1: Survey transplant candidates about their social network and transplant-related attitudes, knowledge, and characteristics; and randomize participants into one of two interventions or a control group.
AIM 2: Send network member participants a survey that measures potential donor attributes that are hypothesized to influence donation decisions, such as medical contraindications, blood type, health insurance status, and barriers to living donation.
AIM 3: Test whether participant social networks and interventions affect donation outcomes using medical records and follow-ups provided by Penn and UAB. Investigators will create the first predictive model of potential donor evaluation and actual donation. This information is critical to improve clinical practice and efforts to ethically influence the living donor search process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There are two interventions randomly assigned to participants in a factorial experimental design. The first intervention is the search intervention. In addition to the candidate survey, transplant candidates assigned to this intervention will be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. The second intervention is the script intervention, where in addition to the survey, transplant candidates will review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. 25% of participants will be assigned to each of the following factorial experimental groups: no intervention, search intervention only, script intervention only, or both search and script intervention.
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –This group will only complete study survey and refer members of their family and social network for participation in a web survey. |
| Script Intervention | Experimental | Behavioral: Script InterventionThis group will complete the survey, refer members of their family and social network for participation in a web survey, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. |
| Search Intervention | Experimental | Behavioral: Search InterventionThis group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. |
| Both Search and Script Intervention | Experimental | Behavioral: Script Intervention, Behavioral: Search InterventionThis group will complete the candidate survey, refer members of their family and social network for participation in a web survey, be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation, and review a set of suggested talking points and an example script to guide discussion of potential living donation with members of their network. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are KT candidates at the University of Pennsylvania or University of Alabama-Birmingham OR were identified by KT candidate from the University of Pennsylvania or University of Alabama-Birmingham as a network member
- Are adults aged 18 or older
- Are able and willing to consent to participation in the survey
Key exclusion criteria (3 listed)
- Person is not a KT candidate at University of Pennsylvania or University of Alabama-Birmingham OR was NOT identified by KT candidate from University of Pennsylvania or University of Alabama-Birmingham as a network member
- Individuals who are not yet 18
- Participant does not speak English
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 |
|---|---|---|
| Script InterventionThis intervention provides language to participants to allow them to discuss kidney transplantation with their social network. | Behavioural | Both Search and Script Intervention, Script Intervention |
| Search InterventionThis group will complete the candidate survey, refer members of their family and social network for participation in a web survey, and be given information about the statistical likelihood that each member of their social network will be free of contraindications for living kidney donation. | Behavioural | Both Search and Script Intervention, Search Intervention |
Primary outcome
Received a living donor kidney transplant
Time frame: up to 3 years
Living donor kidney transplant received by patient
Received a deceased donor kidney transplant
Time frame: up to 3 years
Deceased donor kidney transplant received by patient
Death
Time frame: up to 3 years
Patient died during the follow-up period
Completed living kidney donor screening questionnaires
Time frame: up to 3 years
Number of completed living kidney donation screening questionnaires completed for patient
Preliminary approval from living kidney donor screening questionnaires
Time frame: up to 3 years
Number of completed living kidney donor screening that received preliminary approval for patient
Completed living kidney donor evaluations
Time frame: up to 3 years
Number of living kidney donor evaluations completed for patient
Approvals for living kidney donor candidacy
Time frame: up to 3 years
Number of completed living kidney donor evaluations that resulted in approved living kidney donor candidacy for patient
6 secondary outcomes
Preference for living kidney donor
Time frame: Immediate
Concerns about living kidney donation
Time frame: Immediate
Living donor kidney transplant willingness
Time frame: Immediate
Self-rated kidney transplant knowledge
Time frame: Immediate
Trust in medical institutions
Time frame: Immediate
Religious views' effect on kidney transplant willingness
Time frame: Immediate
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 24 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Script Intervention and Search Intervention in people with End-stage Renal Disease, run by Penn State University at 2 sites 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 3 inclusion and 3 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Received a living donor kidney transplant (time frame: up to 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.