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This pilot study shows a digital self-management program for chronic kidney disease (CKD) is feasible and acceptable. The virtual randomized controlled trial (RCT) met progression criteria, paving the way for a definitive study.

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Area of Science:

  • Nephrology
  • Digital Health
  • Clinical Trials

Background:

  • Self-management is crucial for effective chronic kidney disease (CKD) care.
  • A digital self-management program, 'My Kidneys & Me' (MK&M), was piloted.
  • This study evaluated the feasibility and acceptability of a multicentre randomized controlled trial (RCT) for the MK&M program.

Purpose of the Study:

  • To assess the feasibility and acceptability of a virtually delivered RCT for a digital CKD self-management program.
  • To evaluate recruitment, randomisation, intervention activation, and retention rates.
  • To gather participant feedback for protocol refinement.

Main Methods:

  • A 10-week internal pilot of a multicentre RCT involving 60 participants (CKD stages 3-4) across England.
  • Participants were virtually recruited and randomised 2:1 to the MK&M intervention or control group.
  • Feasibility and acceptability were assessed against pre-specified criteria, with semi-structured interviews for qualitative insights.

Main Results:

  • All progression criteria were met, indicating feasibility for a definitive RCT.
  • 41 participants were randomised to MK&M and 19 to control; 62% completed post-intervention measures.
  • Interviews revealed satisfaction with virtual recruitment, randomisation, and online assessments, with suggestions for improvement.

Conclusions:

  • The internal pilot successfully demonstrated the feasibility and acceptability of a virtually conducted RCT for a digital CKD self-management program.
  • Progression criteria were met, supporting the transition to a definitive trial.
  • Identified areas for improvement led to protocol amendments for enhanced trial delivery.