Kidney Transplant
Conditions
Keywords
Interventional Counseling, Kidney Transplant, Interventional Mapping, Counseling, Social Support Networks, Dialysis
Brief summary
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.
Interventions
Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
Sponsors
University of Minnesota
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
This is a pilot feasibility study, but statisticians will be blinded to group assignment when assessing outcomes
Intervention model description
A control group versus interventional group. Interventional group and their social support network will complete questionnaire.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Decisional Conflict Scores | one month | questionnaire (Ottawa Decisional Conflict scale) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Pre-Transplant Counseling Intervention Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. | 8 |
| 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 | 15 |
| Total | 23 |
Baseline characteristics
| Characteristic | Usual Pre-Transplant Counseling Intervention | Total | Social Support Network Counseling Intervention |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 12.6 | 60 years STANDARD_DEVIATION 11.5 | 60 years STANDARD_DEVIATION 11.3 |
| Education High School Diploma | 3 Participants | 6 Participants | 3 Participants |
| Education Some College or Higher | 4 Participants | 14 Participants | 10 Participants |
| Education Some High School | 1 Participants | 3 Participants | 2 Participants |
| Employment Employed Full Time | 1 Participants | 4 Participants | 3 Participants |
| Employment Employed Part Time | 1 Participants | 2 Participants | 1 Participants |
| Employment Full-Time Homemaker | 1 Participants | 1 Participants | 0 Participants |
| Employment Retired | 4 Participants | 10 Participants | 6 Participants |
| Employment Unable to Work | 0 Participants | 1 Participants | 1 Participants |
| Employment Unemployed | 1 Participants | 5 Participants | 4 Participants |
| Income < $15,000 | 2 Participants | 4 Participants | 2 Participants |
| Income $15,000-30,000 | 2 Participants | 4 Participants | 2 Participants |
| Income $30,000-45,000 | 1 Participants | 4 Participants | 3 Participants |
| Income $45,0000-60,000 | 0 Participants | 1 Participants | 1 Participants |
| Income $60,000-75,000 | 1 Participants | 2 Participants | 1 Participants |
| Income >$75,000 | 0 Participants | 5 Participants | 5 Participants |
| Income Choose not to answer | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Latinx | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 12 Participants | 11 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 14 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
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?
Time frame: one month
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 1 | Answered Correctly | 6 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 1 | Answered Incorrectly | 2 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 2 | Answered Correctly | 8 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 2 | Answered Incorrectly | 0 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 3 | Answered Correctly | 6 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 3 | Answered Incorrectly | 2 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 4 | Answered Correctly | 3 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 4 | Answered Incorrectly | 5 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 5 | Answered Correctly | 0 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 5 | Answered Incorrectly | 8 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 6 | Answered Correctly | 0 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 6 | Answered Incorrectly | 8 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 7 | Answered Correctly | 4 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 7 | Answered Incorrectly | 4 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 8 | Answered Correctly | 2 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 8 | Answered Incorrectly | 6 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 9 | Answered Correctly | 1 Participants |
| Usual Pre-Transplant Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 9 | Answered Incorrectly | 7 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 7 | Answered Incorrectly | 9 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 1 | Answered Correctly | 14 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 5 | Answered Incorrectly | 6 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 1 | Answered Incorrectly | 1 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 9 | Answered Incorrectly | 4 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 2 | Answered Correctly | 15 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 6 | Answered Correctly | 10 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 2 | Answered Incorrectly | 0 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 8 | Answered Correctly | 10 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 3 | Answered Correctly | 13 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 6 | Answered Incorrectly | 5 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 3 | Answered Incorrectly | 2 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 9 | Answered Correctly | 11 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 4 | Answered Correctly | 9 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 7 | Answered Correctly | 6 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 4 | Answered Incorrectly | 6 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 8 | Answered Incorrectly | 5 Participants |
| Social Support Network Counseling Intervention | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question 5 | Answered Correctly | 9 Participants |
Secondary
Difference in Decisional Conflict Scores
questionnaire (Ottawa Decisional Conflict scale)
Time frame: one month
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Do you feel sure about the best choice for you? | Yes | 7 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Do you feel sure about the best choice for you? | No | 1 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Do you know the benefits and risks of getting a kidney transplant? | Yes | 4 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Do you know the benefits and risks of getting a kidney transplant? | No | 4 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Are you clear about which benefits and risks matter most to you? | Yes | 6 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Are you clear about which benefits and risks matter most to you? | No | 2 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Do you have enough support and advice to make a choice? | Yes | 6 Participants |
| Usual Pre-Transplant Counseling Intervention | Difference in Decisional Conflict Scores | Do you have enough support and advice to make a choice? | No | 2 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Do you have enough support and advice to make a choice? | No | 0 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Do you feel sure about the best choice for you? | Yes | 14 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Are you clear about which benefits and risks matter most to you? | Yes | 15 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Do you feel sure about the best choice for you? | No | 1 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Do you have enough support and advice to make a choice? | Yes | 15 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Do you know the benefits and risks of getting a kidney transplant? | Yes | 15 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Are you clear about which benefits and risks matter most to you? | No | 0 Participants |
| Social Support Network Counseling Intervention | Difference in Decisional Conflict Scores | Do you know the benefits and risks of getting a kidney transplant? | No | 0 Participants |