JtT: Social Support Counseling Intervention for Kidney Transplant Candidates

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06147076

Collaborator

University of Minnesota (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Virtual Coaching for Potential Kidney Transplant Patients

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant	Behavioral: Social Support Network Counseling Intervention	N/A

Detailed Description

Individuals who are eligible for kidney transplant will be recruited by phone or email and 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 group education and counseling session along with members of their social support networks. The interventional counseling will then complete a pre and post survey (same as control group). Survey answers will be recorded within REDCAP.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Control group versus interventional group. Questionnaire completed by interventional group and their social support networks pre and post.Control group versus interventional group. Questionnaire completed by interventional group and their social support networks pre and post.

Masking:

Single (Outcomes Assessor)

Masking Description:

Statisticians will be blinded to group assignment when assessing outcomes.

Primary Purpose:

Supportive Care

Official Title:

Journey to Transplant: Virtual Coaching for Potential Kidney Transplant Patients and Their Social Support Networks

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Pre-Transplant Counseling Intervention Participants in control arm will undergo usual pre-transplant counseling as per the standard of care.
Experimental: Social Support Network Counseling Intervention Participants in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks after their initial transplant evaluation and counseling.	Behavioral: Social Support Network Counseling Intervention Social support counseling intervention for kidney transplant candidates along with their social support networks.

Arm

Intervention/Treatment

No Intervention: Usual Pre-Transplant Counseling Intervention

Participants in control arm will undergo usual pre-transplant counseling as per the standard of care.

Experimental: Social Support Network Counseling Intervention

Participants in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks after their initial transplant evaluation and counseling.

Behavioral: Social Support Network Counseling Intervention

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

Outcome Measures

Primary Outcome Measures

Correct Answers on Knowledge of Kidney Transplant Options Assessment [one month]
Questionnaire

Secondary Outcome Measures

Decisional Conflict Scores [one month]
Questionnaire
Social Support Scores [one month]
Questionnaire
Knowledge Scores [one month]
Questionnaire
Hearth Hope Index [one month]
Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion

Determined by transplant center to be suitable for continuation in evaluation for listing (or a member of that person's social support network)
18 Years of age or older
English-speaking
Willingness to participate with at least 2 social network members in the session and have calculator results shown to social network members (if a patient)
Able to provide informed consent

Exclusion