Pilot Social Support Counseling Intervention for Kidney Transplant Candidates

NCT04363515 | Completed Results

• 1 other identifier: HSR 19-4710
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility pilot social support counseling intervention for kidney transplant candidates

Conditions

Kidney Transplant

Keywords

Interventional Counseling; Kidney Transplant; Interventional Mapping; Counseling; Social Support Networks; Dialysis

Outcome Measures

Primary Outcomes (1)

• 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?

  one month

Secondary Outcomes (1)

• Difference in Decisional Conflict Scores

  one month

Study Arms (2)

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

Behavioral: Social support network counseling intervention

Interventions

Social support network counseling intervention BEHAVIORAL

Pilot social support counseling intervention for kidney transplant candidates along with their social support networks

Social Support Network Counseling Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• University of Minnesota: collaborator

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

Related Links

• American Transplant Congress oral abstract

Results Point of Contact

• Title: Dr. Allyson Hart
• Organization: Hennepin Healthcare Research Institute

allyson.hart@hcmed.org

612-873-6998

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a pilot feasibility study, but statisticians will be blinded to group assignment when assessing outcomes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A control group versus interventional group. Interventional group and their social support network will complete questionnaire.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: August 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Locations

US (1)