NCT05459337

Brief Summary

For people living with kidney failure, the two active treatment options are dialysis or kidney transplantation. Transplantation is optimal, and especially from a living donor - offering patients longer survival, a better quality of life, and cost savings for the health system when compared to dialysis. However, 20% of patients die on dialysis while waiting for a deceased donor organ. As the rate of kidney failure continues to rise, the gap between demand and supply of the organs for transplantation increases. Compared to other provinces in Canada, the rate of living kidney donor transplantation is lower in Alberta, so it is essential that improvements are made to the process around living kidney donor transplantation, for better patient outcomes and care. Our published evidence-based review on strategies to increase living kidney donation, found that for patients with kidney failure, the intervention with the greatest health impact was personalized support, provided by a multidisciplinary team, to inform and educate the patients' social network. A province-wide survey also confirmed that many patients with kidney failure are unable to find a living kidney donor and also find it difficult to approach potential donors due to lack of skills, supports, and resources. The investigators have developed the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention to support potential kidney transplant recipients find living donors through their social networks, and thereby increase the number of living kidney donor transplants in Alberta. The investigators will test the effectiveness of this intervention.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2022Sep 2026

First Submitted

Initial submission to the registry

June 22, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

June 22, 2022

Last Update Submit

January 5, 2026

Conditions

Living Donor Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Living Kidney Donor Transplantation

    Proportion of participants undergoing living kidney donor transplantations

    24 months

Secondary Outcomes (3)

  • Living Kidney Donor Evaluation Approved

    12 months

  • Living Kidney Donor Evaluation Started

    12 months

  • Contact Living Donor Services

    12 months

Other Outcomes (20)

  • Consent rate

    From start date to end date of study recruitment, up to 1 year

  • Reasons for decline of consent

    From start date to end date of study recruitment, up to 1 year

  • Non-completion of initial screening

    From start date to end date of study recruitment, up to 1 year

  • +17 more other outcomes

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 AKTBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • No obvious contraindication to kidney transplantation
  • Successfully 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

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
Model Details: Parallel block randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 14, 2022

Study Start

October 18, 2022

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)