Canadian journal of kidney health and disease · 2023
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.
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Selzler Anne-Marie, Davoodi Parastoo Molla, Klarenbach Scott, Lam Ngan N, Smith Terry, Ackroyd Abigail, Wiebe Natasha, Corradetti Bonnie, Ferdinand Sharron, Iyekekpolor Dorothy, Smith Gordon, Verdin Nancy, Bello Aminu K, Wen Kevin, Shojai Soroush, Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) Research Group
Аннотация
BACKGROUND: Living donor kidney transplantation (LDKT) is the optimal treatment for eligible patients with kidney failure, although it is underutilized. Contextually tailored patient- and family-centered interventions may be effective to increase LDKT.
OBJECTIVE: We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to increase LDKT.
DESIGN: Non-blinded single-center pilot randomized controlled trial with a qualitative interview component.
SETTING: Academic transplant referral center in Northern Alberta Region with a population of more than 2 million in its catchment area.
PATIENTS: English-speaking patients of the age range 18 to 75 years who are referred for kidney transplantation are eligible to participate.
MEASUREMENTS: Feasibility will be assessed by indicators of recruitment, retention, and completion rates, treatment fidelity, adherence to intervention, engagement in intervention, and acceptability.
METHODS: Participants will be randomly assigned 1:1 to either standard care (control) or the experimental group who receive standard care plus the MuST AKT intervention, a person-centered program designed to assist and enable the kidney transplant candidate to achieve what is required to receive an LDKT. The intervention consists of an introductory session and 4 intervention sessions delivered in-person or virtually.
LIMITATIONS: Inferences cannot be drawn regarding the efficacy/effectiveness of the MuST AKT intervention. This study is non-blinded.
CONCLUSIONS: This pilot study is the first step in our broader initiative to increase LDKT in our health care jurisdiction. The results of this study will be used to inform the development of a future definitive randomized controlled trial.
TRIAL REGISTRATION NUMBER: NCT04666545.
OBJECTIVE: We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to increase LDKT.
DESIGN: Non-blinded single-center pilot randomized controlled trial with a qualitative interview component.
SETTING: Academic transplant referral center in Northern Alberta Region with a population of more than 2 million in its catchment area.
PATIENTS: English-speaking patients of the age range 18 to 75 years who are referred for kidney transplantation are eligible to participate.
MEASUREMENTS: Feasibility will be assessed by indicators of recruitment, retention, and completion rates, treatment fidelity, adherence to intervention, engagement in intervention, and acceptability.
METHODS: Participants will be randomly assigned 1:1 to either standard care (control) or the experimental group who receive standard care plus the MuST AKT intervention, a person-centered program designed to assist and enable the kidney transplant candidate to achieve what is required to receive an LDKT. The intervention consists of an introductory session and 4 intervention sessions delivered in-person or virtually.
LIMITATIONS: Inferences cannot be drawn regarding the efficacy/effectiveness of the MuST AKT intervention. This study is non-blinded.
CONCLUSIONS: This pilot study is the first step in our broader initiative to increase LDKT in our health care jurisdiction. The results of this study will be used to inform the development of a future definitive randomized controlled trial.
TRIAL REGISTRATION NUMBER: NCT04666545.