Kidney Transplant; Complications, Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPro-hab program
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.
Sponsors
Ottawa Hospital Research Institute
OHRI ELEVATE Kidney Team Grants Competition
University of Ottawa Anesthesiology and Pain Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Scheduled, or on the pathway, for kidney transplant surgery * Expected surgery date between at least 4 weeks from enrollment * Access to internet-enabled device * Email address
Exclusion criteria
* Inability to read and communicate in English * Cognitive impairment preventing ability to provide informed consent independently * No telephone/cell phone * Any of the following cardiovascular conditions: 1. Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea 2. Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea 3. Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment | One month | \>40% of eligible participants enroll (4/month) would allow us to complete a fully powered (n=312) patient trial in 24 months. |
| Adequate pro-hab program adherence | A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery | \>75% adherence is required to meaningfully benefit from multimodal health-promotion interventions. |
| Adequate patient-reported outcome follow up | One year | \>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data |
Countries
Canada
Contacts
CONTACTDaniel McIsaac, MD
CONTACTEmily Hladkowicz, PhD
PRINCIPAL_INVESTIGATORDaniel McIsaac, MD
The Ottawa Hospital
Outcome results
None listed