Pilot Social Support Counseling Intervention for Kidney Transplant Candidates

NCT ID: NCT04363515

Last Updated: 2025-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-09-30

Brief Summary

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Feasibility pilot social support counseling intervention for kidney transplant candidates

Detailed Description

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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.

Conditions

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Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A control group versus interventional group. Interventional group and their social support network will complete questionnaire.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
This is a pilot feasibility study, but statisticians will be blinded to group assignment when assessing outcomes

Study Groups

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Usual Pre-Transplant Counseling Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Social support network counseling intervention

Intervention Type BEHAVIORAL

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

Interventions

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Social support network counseling intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Other Identifiers

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HSR 19-4710

Identifier Type: -

Identifier Source: org_study_id

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