Multidisciplinary Support To Access Living Donor Kidney Transplant-Pilot

NCT04666545 | Active Not Recruiting

• 1 other identifier: Pro00097902
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with kidney failure the two treatment options are kidney transplantation or dialysis. Transplantation offers longer survival, better quality of life and provides cost savings for the health system (\>$60,000/year per patient). Unfortunately, there are not enough organs available and 20% of patients die on dialysis waiting for a deceased donor kidney. Living kidney donation is a safe and proven treatment that leads to even better patient and health system outcomes than deceased donor kidney transplant. The Kidney Health Strategic Clinical Network (KH-SCN) identified increasing living kidney donation as a priority and in 2015 established the Living Donor Kidney Transplant Working Group (LDKTWG) comprised of patients, donors, health care professionals, researchers, and administrators. In an evidenced review published by the investigators, the intervention with the best evidence and greatest impact was personalized support provided by a multidisciplinary team to inform and educate the patients' social network. This intervention increased living kidney donations by 34%. The investigators confirmed through a province wide survey that many patients with kidney failure are unable to find a living kidney donor and find it difficult to approach potential donors due to lack of skills, supports, and resources and these issues are particularly apparent in vulnerable populations. The investigators have developed the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention to support patients in identifying and communicating with their social networks. The investigators will test the effectiveness of this intervention.

Conditions

Living Donor Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Living Kidney Donor Evaluation Started

  Proportion of participants with at least one potential donor who started evaluation

  12 months

Secondary Outcomes (4)

• Living Kidney Donor Transplantation

  24 months

• Contact Living Donor Services

  12 months

• Living Kidney Donor Evaluation Completed

  12 months

• Identified potential advocates

  From date of first to last documented session, an average of 3 months

Other Outcomes (11)

• Participant recommendation

  At date of last documented session, an average of 3 months

• Perception of program effectiveness (1 item developed for this study)

  At date of last documented session, an average of 3 months

• Self-efficacy for approaching a potential donor as assessed by 1 item developed for this study: "How confident are you that you can talk to a friend or family member about being a potential living kidney donor?"

  3 months (length of intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

This arm will receive the MuST AKT intervention, which is a multidisciplinary, tailored person-centered behavioural intervention designed to "help and enable" the potential kidney transplant recipients to achieve what is required to receive a living donor kidney transplantation.

Behavioral: MuST AKT

Usual Care (control)

NO INTERVENTION

In the usual care (control) condition, participants will go through the current standard of care, which is a social worker assessment.

Interventions

MuST AKT BEHAVIORAL

A behavioural intervention designed to help participants identify and communicate with their social network about living kidney donation.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• No obvious contraindication to kidney transplantation
• Completed 'introduction to kidney transplant' module

You may not qualify if:

• Potential Living Kidney Donor identified
• Previously received organ transplant
• Candidate for multi-organ transplant
• Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) Score \> 20
• Rapid Estimate of Adult Literacy in Medicine (REALM-66) score \< 19 (illiterate in English)

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Selzler AM, Davoodi PM, Klarenbach S, Lam NN, Smith T, Ackroyd A, Wiebe N, Corradetti B, Ferdinand S, Iyekekpolor D, Smith G, Verdin N, Bello AK, Wen K, Shojai S; Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) Research Group. Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT): A Clinical Research Protocol for a Pilot Randomized Controlled Trial to Increase Living Kidney Donation. Can J Kidney Health Dis. 2023 Oct 30;10:20543581231205340. doi: 10.1177/20543581231205340. eCollection 2023.

  PMID: 37920779 DERIVED

Study Officials

• Dr. Shojai

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot parallel block randomized controlled trial

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 14, 2020
• Study Start: May 12, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)