Kidney TransplantNCT04363515
Pilot Social Support Counseling Intervention for Kidney Transplant Candidates
A study testing Social support network counseling intervention in people with Kidney Transplant, run by Allyson Hart at 1 site in United States.
Trial summary
Feasibility pilot social support counseling intervention for kidney transplant candidates Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Social support network counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between ages 18-80
- Being considered for kidney transplant
- Part of social support network for an individual being considered for kidney transplant.
- Physically and Mentally able to participate.
Who cannot join
- Non-English speaking individuals.
- Individuals with impaired ability to consent.
- Candidates for combined organ Transplant.
- Patients who choose to opt out of research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
About this study
Feasibility pilot social support counseling intervention for kidney transplant candidates
Read the detailed description
Individuals who are eligible for kidney transplant will be randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a second counseling session along with members of their social support networks. The interventional counseling will then complete the survey (same as control group). Survey answers will be recorded within REDCAP.
- Conditions
- Kidney Transplant
- Being tested
- Social support network counseling intervention
- Keywords
- Interventional Counseling, Kidney Transplant, Interventional Mapping, Counseling, Social Support Networks, Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social support network counseling interventionBehavioural
Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
| Study group | Role | What they receive |
|---|---|---|
| Usual Pre-Transplant Counseling Intervention | No intervention | Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. |
| Social Support Network Counseling Intervention | Experimental | Subjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling Receives: Behavioral: Social support network counseling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question key (true/false, multiple choice)
- A patient on dialysis has the same level of kidney functioning as a patient with a transplanted kidney.
- In general, patients can live at least 5 years longer with a kidney transplant than if they stayed on dialysis.
- In general, most people on dialysis are happier with the quality of their lives than people with transplants.
- Patients have better health outcomes if they receive a transplant before starting dialysis.
- If a patient waits long enough on the waitlist, a matching kidney from someone who has died will definitely become available.
- About what percentage of all transplanted kidneys function for at least one year?
- Nationally, how long do patients generally wait on the waitlist for a kidney from someone who has died?
- Compared to transplants from donors who have died, how long do transplants from living donors last?
- What is the chance that a living donor or recipient would die undergoing surgery?
Measured: one month
Secondary outcomes (1)
Difference in Decisional Conflict Scores
questionnaire (Ottawa Decisional Conflict scale)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Aug 2020
- Primary completion31 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A control group versus interventional group. Interventional group and their social support network will complete questionnaire.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allyson Hart
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor-investigator, Allyson Hart, Hennepin Healthcare Research Institute
- Investigators
- Allyson Hart, MD, Principal investigator, Hennepin Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363515
- Sponsor's protocol ID
- HSR 19-4710
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2020
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There might be an exchange of data with our collaborators with the study at the University of Minnesota-Twin Cities
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Social Support Counseling Intervention for Kidney Transplant Candidates
- ClinicalTrials.gov ID
- NCT04363515
- Acronym / sponsor ID
- HSR 19-4710
- Conditions
- Kidney Transplant
- Keywords
- Interventional Counseling, Kidney Transplant, Interventional Mapping, Counseling, Social Support Networks, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Allyson HartUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility pilot social support counseling intervention for kidney transplant candidates
Detailed description
Individuals who are eligible for kidney transplant will be randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a second counseling session along with members of their social support networks. The interventional counseling will then complete the survey (same as control group). Survey answers will be recorded within REDCAP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A control group versus interventional group. Interventional group and their social support network will complete questionnaire.
| Arm | Type | Receives |
|---|---|---|
| Usual Pre-Transplant Counseling Intervention | No intervention | –Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. |
| Social Support Network Counseling Intervention | Experimental | Behavioral: Social support network counseling interventionSubjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between ages 18-80
- Being considered for kidney transplant
- Part of social support network for an individual being considered for kidney transplant.
- Physically and Mentally able to participate.
Key exclusion criteria (4 listed)
- Non-English speaking individuals.
- Individuals with impaired ability to consent.
- Candidates for combined organ Transplant.
- Patients who choose to opt out of research.
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 |
|---|---|---|
| Social support network counseling interventionPilot social support counseling intervention for kidney transplant candidates along with their social support networks | Behavioural | Social Support Network Counseling Intervention |
Primary outcome
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Time frame: one month
Question key (true/false, multiple choice) 1. A patient on dialysis has the same level of kidney functioning as a patient with a transplanted kidney. 2. In general, patients can live at least 5 years longer with a kidney transplant than if they stayed on dialysis. 3. In general, most people on dialysis are happier with the quality of their lives than people with transplants. 4. Patients have better health outcomes if they receive a transplant before starting dialysis. 5. If a patient waits long enough on the waitlist, a matching kidney from someone who has died will definitely become available. 6. About what percentage of all transplanted kidneys function for at least one year? 7. Nationally, how long do patients generally wait on the waitlist for a kidney from someone who has died? 8. Compared to transplants from donors who have died, how long do transplants from living donors last? 9. What is the chance that a living donor or recipient would die undergoing surgery?
1 secondary outcome
Difference in Decisional Conflict Scores
Time frame: one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- American Transplant Congress oral abstractLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. There might be an exchange of data with our collaborators with the study at the University of Minnesota-Twin Cities
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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.
Allyson Hart, MD principal investigator
Hennepin Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social support network counseling intervention in people with Kidney Transplant, run by Allyson Hart 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 4 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 6 Oct 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment (time frame: one month). 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 6 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.