Pilot Social Support Counseling Intervention for Kidney Transplant Candidates

Feasibility pilot social support counseling intervention for kidney transplant candidates

Study Overview

• Status: Completed
• Conditions: Kidney Transplant
• Intervention / Treatment: Behavioral: Social support network counseling intervention

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Pre-Transplant Counseling Intervention; Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care.
Experimental: 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	Behavioral: Social support network counseling intervention; Pilot social support counseling intervention for kidney transplant candidates along with their social support networks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Decisional Conflict Scores	questionnaire (Ottawa Decisional Conflict scale)	one month

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: University of Minnesota

Publications and helpful links

Helpful Links

• American Transplant Congress oral abstract

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Counseling; Dialysis; Kidney Transplant; Interventional Counseling; Interventional Mapping; Social Support Networks
• Other Study ID Numbers: HSR 19-4710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There might be an exchange of data with our collaborators with the study at the University of Minnesota-Twin Cities

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No