Pilot Social Support Counseling Intervention for Kidney Transplant Candidates

Not Applicable

Completed

• Conditions: Kidney Transplant
• Interventions: Behavioral: Social support network counseling intervention

• Registration Number: NCT04363515
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Study Start: 2020-08-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-09-30
• Results First Submitted: 2023-08-07
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Results First Posted: 2025-03-10
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Support Network Counseling Intervention	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Difference in Decisional Conflict Scores	one month	questionnaire (Ottawa Decisional Conflict scale)

Trial Locations

Locations (1)

Hennepin Healthcare Research Institute; 🇺🇸 Minneapolis, Minnesota, United States