Trial Outcomes & Findings for Pilot Social Support Counseling Intervention for Kidney Transplant Candidates (NCT NCT04363515)
NCT ID: NCT04363515
Last Updated: 2025-03-10
Results Overview
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?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
one month
Results posted on
2025-03-10
Participant Flow
Participants for the feasibility pilot trial were recruited from two transplant centers in Minnesota, Hennepin Healthcare and The University of Minnesota, between August 2020 and March 2021.
Participant milestones
| Measure |
Usual Pre-Transplant Counseling Intervention
Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care.
|
Social Support Network Counseling Intervention
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
Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
15
|
|
Overall Study
COMPLETED
|
8
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Social Support Counseling Intervention for Kidney Transplant Candidates
Baseline characteristics by cohort
| Measure |
Usual Pre-Transplant Counseling Intervention
n=8 Participants
Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care.
|
Social Support Network Counseling Intervention
n=15 Participants
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
Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
60 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latinx
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
Some High School
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
High School Diploma
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
Some College or Higher
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Income
< $15,000
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Income
$15,000-30,000
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Income
$30,000-45,000
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Income
$45,0000-60,000
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Income
$60,000-75,000
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Income
>$75,000
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Income
Choose not to answer
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Employment
Retired
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Employment
Unemployed
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment
Full-Time Homemaker
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment
Employed Full Time
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Employment
Employed Part Time
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment
Unable to Work
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one monthQuestion 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?
Outcome measures
| Measure |
Usual Pre-Transplant Counseling Intervention
n=8 Participants
Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care.
|
Social Support Network Counseling Intervention
n=15 Participants
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
Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
|
|---|---|---|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 1 · Answered Incorrectly
|
2 Participants
|
1 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 2 · Answered Incorrectly
|
0 Participants
|
0 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 4 · Answered Correctly
|
3 Participants
|
9 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 4 · Answered Incorrectly
|
5 Participants
|
6 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 6 · Answered Correctly
|
0 Participants
|
10 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 6 · Answered Incorrectly
|
8 Participants
|
5 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 7 · Answered Correctly
|
4 Participants
|
6 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 8 · Answered Incorrectly
|
6 Participants
|
5 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 9 · Answered Correctly
|
1 Participants
|
11 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 1 · Answered Correctly
|
6 Participants
|
14 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 2 · Answered Correctly
|
8 Participants
|
15 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 3 · Answered Correctly
|
6 Participants
|
13 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 3 · Answered Incorrectly
|
2 Participants
|
2 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 5 · Answered Correctly
|
0 Participants
|
9 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 5 · Answered Incorrectly
|
8 Participants
|
6 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 7 · Answered Incorrectly
|
4 Participants
|
9 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 8 · Answered Correctly
|
2 Participants
|
10 Participants
|
|
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
Question 9 · Answered Incorrectly
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: one monthquestionnaire (Ottawa Decisional Conflict scale)
Outcome measures
| Measure |
Usual Pre-Transplant Counseling Intervention
n=8 Participants
Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care.
|
Social Support Network Counseling Intervention
n=15 Participants
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
Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
|
|---|---|---|
|
Difference in Decisional Conflict Scores
Do you feel sure about the best choice for you? · Yes
|
7 Participants
|
14 Participants
|
|
Difference in Decisional Conflict Scores
Do you feel sure about the best choice for you? · No
|
1 Participants
|
1 Participants
|
|
Difference in Decisional Conflict Scores
Do you have enough support and advice to make a choice? · Yes
|
6 Participants
|
15 Participants
|
|
Difference in Decisional Conflict Scores
Do you have enough support and advice to make a choice? · No
|
2 Participants
|
0 Participants
|
|
Difference in Decisional Conflict Scores
Do you know the benefits and risks of getting a kidney transplant? · Yes
|
4 Participants
|
15 Participants
|
|
Difference in Decisional Conflict Scores
Do you know the benefits and risks of getting a kidney transplant? · No
|
4 Participants
|
0 Participants
|
|
Difference in Decisional Conflict Scores
Are you clear about which benefits and risks matter most to you? · Yes
|
6 Participants
|
15 Participants
|
|
Difference in Decisional Conflict Scores
Are you clear about which benefits and risks matter most to you? · No
|
2 Participants
|
0 Participants
|
Adverse Events
Usual Pre-Transplant Counseling Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Social Support Network Counseling Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Allyson Hart
Hennepin Healthcare Research Institute
Phone: 612-873-6998
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place