Social Support Counseling Intervention for Kidney Transplant Candidates

NCT06147076 | Recruiting

• 1 other identifier: 1R01DK135730-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual Coaching for Potential Kidney Transplant Patients

Conditions

Kidney Transplant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correct Answers on Knowledge of Kidney Transplant Options Assessment

  Questionnaire

  one month

Secondary Outcomes (4)

• Decisional Conflict Scores

  one month

• Social Support Scores

  one month

• Knowledge Scores

  one month

• Hearth Hope Index

  one month

Study Arms (2)

Usual Pre-Transplant Counseling Intervention

NO INTERVENTION

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

Social Support Network Counseling Intervention

EXPERIMENTAL

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

Interventions

Social Support Network Counseling Intervention BEHAVIORAL

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

Social Support Network Counseling Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Determined by transplant center to be suitable for continuation in evaluation for listing (or a member of that person's social support network)
• 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

You may not qualify if:

• Prisoners
• Individuals with impaired ability to consent
• Pregnant females.
• Patients who choose to opt out of research.
• Non-English speaking

Sponsors & Collaborators

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

Study Sites (1)

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

RECRUITING

Related Links

• American Transplant Congress oral abstract

Central Study Contacts

Allyson Hart, MD

CONTACT

612-873-6998; allyson.hart@hcmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians will be blinded to group assignment when assessing outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 27, 2023
• Study Start: August 20, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (1)