The PRO-Active rehabilitation prior to Kidney Transplantation to ImproVe patient-centered recovery Evaluation trial tests an approach where people are supported to exercise, improve diet, and receive emotional support at home before and after kidney transplant surgery to understand the ideal process and benefits.
Background: Many Canadians are waiting for a kidney transplant, using this wait time to improve health before surgery could mean better outcomes. Proactive rehabilitation (pro-hab) is an approach where people are supported to exercise, improve their diet, and have emotional support before surgery, and during their recovery at home. Overarching Aim: The PROAKTIVE Pilot Trial will test an approach where people are supported to exercise, improve diet, and receive emotional support at home before and after kidney transplant surgery to understand the ideal process and benefits. Methods: Design, setting and participants: The PROAKTIVE Pilot trial is a single arm, prospective trial design where eligible participants are enrolled into the pro-hab program. People \>/= 18 years old who will undergo kidney transplant surgery will be included. Intervention: The intervention will be a multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant. The program will be supported virtually using an established, non-commercial platform available on computer, tablet or smartphone. Outcomes and sample size: The outcomes are: enrollment, program adherence, patient-reported outcome follow-up. The sample size for this stage will be 45, which will provide 80% power to rule out \<75% adherence (5% significance) based on our past experience achieving 90% adherence in related populations. Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives. Expected outcomes: The PROAKTIVE Pilot Trial will develop, evaluate and implement a multimodal proactive rehabilitation (pro-hab) program that effectively improves patient-centered recovery and resource use for patient waiting for, and recovering after, kidney transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant, including exercise, breathing, nutrition, and psychosocial support.
The Ottawa Hospital
Ottawa, Ontario, Canada
Enrollment
\>40% of eligible participants enroll (4/month) would allow us to complete a fully powered (n=312) patient trial in 24 months.
Time frame: One month
Adequate pro-hab program adherence
\>75% adherence is required to meaningfully benefit from multimodal health-promotion interventions.
Time frame: A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery
Adequate patient-reported outcome follow up
\>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data
Time frame: One year
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