MO1052: Feasibility of ‘Smile-K’, a Remote Randomized Controlled Trial of an Online Self-Management Programme for People Living with Kidney Disease
Authors: Lightfoot Courtney J , Wilkinson Thomas , Vadaszy Noemi , Smith Alice 
Published: May 2022

Abstract

BACKGROUND AND AIMS
It is desirable for people with non-dialysis chronic kidney disease (ND-CKD) to take an active role in the management of their own health, but this requires the appropriate knowledge, skills and confidence (termed patient activation) to effectively self-manage. Currently, there is a lack of resources available to improve self-management behaviours and actively involve individuals in their own healthcare. Our group has developed a 10-week online self-management programme for people with non-dialysis CKD, called ‘My Kidneys & Me’ (MK&M), currently undergoing evaluation in the ‘SMILE-K’ multi-centre randomized control trial (RCT), which is conducted entirely online (remotely). The primary outcome of ‘SMILE-K’ is patient activation, but to ensure that the full-scale trial protocol is feasible and to minimize methodological weaknesses, we conducted a nested single-blind pilot with feasibility outcomes. Here we report the results of the nested pilot and preliminary usage data for ‘MK&M’.

METHOD
The ‘SMILE-K’ trial employs an entirely remote recruitment method, with a 2:1 randomization into intervention and control arms. The first 60 participants were included in the nested pilot and followed up for 10-weeks. Assessment surveys, including the Patient Activation Measure, were conducted electronically at baseline (pre-randomization) and 10 weeks later. Progression criteria were set a priori, using the ‘red’ (stop), ‘amber’ (make changes) and ‘green’ (go) system to specify targets for progression, based on recruitment rates, acceptability of recruitment and randomization methods, the feasibility and acceptability of outcome assessments, and engagement with and usage of ‘MK&M’.

RESULTS
Of the first 128 people approached who expressed interest in ‘SMILE-K’, 77/128 (60%) consented to participate. Of these, 60/77 (78%) completed the baseline
outcome survey and were subsequently randomized and included in the pilot. The average age of pilot participants was 63 (range: 20–88) years and 63% (n = 38) were male. Sending study invitations via post was the most common method of recruitment, although additional discussion of the study with potential participants (either face-to-face or via telephone) increased recruitment rates. All of the pre-specified ‘stop’ progression criteria thresholds were exceeded, indicating that the full planned RCT is feasible. Access to and engagement with ‘MK&M’ were high, with 36/41 (88%) participants activating their accounts and logging in. Participants logged into ‘MK&M’ a mean of 35 times during the 10-week follow-up period and spent a mean of 14 min/login.

CONCLUSION
This nested pilot study provided evidence for the feasibility of the full-scale ‘SMILE-K’ trial. Numerous lessons were learnt from conducting this entirely remote trial design, and from the pilot findings, we identified areas for improvement and have made subsequent small amendments to the trial protocol to improve the delivery of ‘MK&M’ and ‘SMILE-K’. The ‘SMILE-K’ trial is currently ongoing, and we anticipate that the results will be available in 2023.