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Abstract: SA-PO946

Feasibility of a Remotely Delivered Trial Testing an Online Self-Management Programme for People Living With CKD

Session Information

Category: CKD (Non-Dialysis)

  • 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

  • Lightfoot, Courtney Jane, University of Leicester, Leicester, United Kingdom
  • Wilkinson, Thomas James, University of Leicester, Leicester, United Kingdom
  • Vadaszy, Noemi, University of Leicester, Leicester, United Kingdom
  • Smith, Alice C., University of Leicester, Leicester, United Kingdom
Background

Self-management of a long-term health condition, like CKD, requires appropriate knowledge, skills, and confidence (termed patient activation). However, resources to support and improve self-management behaviours in CKD are lacking. We developed a 10-week online self-management programme for people with non-dialysis CKD, called My Kidneys & Me (MK&M). This programme is being evaluated in an ongoing multi-centre randomised control trial (called SMILE-K). To ensure that the full-scale trial protocol is feasible, we conducted a mixed-methods nested feasibility pilot involving the first 60 participants.

Methods

The SMILE-K trial is conducted entirely using remote recruitment and outcome assessment methods. It has a 2:1 (intervention:control) randomisation. Assessment surveys, including the Patient Activation Measure, are collected at baseline and at 10 weeks. Based on recruitment rates, acceptability of recruitment and randomisation methods, feasibility and acceptability of outcome assessments, and engagement with and usage of MK&M, a-priori progression criteria were set using a ‘red’ (stop), ‘amber’ (make changes) and ‘green’ (go) system. Semi-structured interviews explored participant views of the trial design.

Results

128 people expressed initial interest in the study, of which 77 (60%) consented to participate. 60/77 (78%) completed the baseline survey and were randomised and included in the pilot. Mean age was 63 (range: 20-88) years and 63% were male. All the pre-specified ‘stop’ progression criteria thresholds were exceeded, suggesting the full trial is feasible. Access to and engagement with MK&M were high with 36/41 (88%) participants in the intervention group activating their account. On average participants logged in 35 times during the 10 weeks spending a mean of 18 minutes per login. Participants described their views and experiences of taking part in this remote trial, including email communication, engaging in online assessments, online education and suggestions for improvements to full study protocol.

Conclusion

This nested pilot study provides evidence for the feasibility of the full-scale trial. Consequent refinements to the protocol have been made through the identified areas for improvement. These results are relevant to inform the design of other remotely delivered trials in CKD.