Health TrialsbyHealthPanel

Telemedicine to Support Living Kidney Donor Candidates

ConditionsHealthyLiving Kidney Donation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are:

* Is telemedicine a practical way to facilitate donor education and evaluation and counseling? * Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process?

Researchers will compare standard care with a telemedicine care coordination approach.

Participants will:

\- Receive either standard care or telemedicine video visits to support shared decision making.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

Reside in the State of California

Registered living kidney donor candidate at UC Irvine Medical Center

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Care (in control arm)

    Behavioral

    This Standard Care involves a recorded video education and in-person visit.

  • Telemedicine Shared Decision-Making

    Behavioral

    This intervention involves two live telemedicine video visits.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Standard Care Group (Control)Active comparator 1 intervention
Group B: Telemedicine Group (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Proportion of eligible participants who consent and enroll in the study, calculated as the number enrolled divided by the number of eligible participants approached.

Time frame
90 days
2

Retention Rate

Proportion of enrolled participants who remain in the study through the 90-day follow-up period, calculated as the number completing final follow-up divided by the number enrolled.

Time frame
90 days
3

Change in Decisional Conflict Measured by the Decisional Conflict Scale (DCS)

Decision conflict will be measured using the Decisional Conflict Scale (DCS), a 16-item validated instrument. Each item is scored from 0 (no conflict) to 100 (very high conflict), and a total score is calculated by averaging across items. Total scores therefore range from 0 to 100, with higher scores indicating worse decision conflict and greater uncertainty.

Time frame
90 days

Secondary outcomes

1

Completion of Donor Education and Evaluation and Counseling

Completion of donor education and evaluation and counseling. Time to donor evaluation and counseling completion.

Time frame
90 days
2

Intervention Acceptability

Participant-reported acceptability of the telemedicine intervention will be measured using the acceptability of intervention measure. This outcome will be assessed only in the Telemedicine Intervention Arm.

Time frame
Post-telemedicine session 1 at 7 days, and telemedicine session 2 at 67 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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