What is the purpose of the study?
SMILE-K aimed to develop and test the digital intervention My Kidneys & Me (MK&M) in order to improve and maintain effective self-management behaviours, including physical activity and lifestyle, to improve knowledge, promote self-care skills, increase self-efficacy, and enhance well-being in people with non-dialysis chronic kidney disease.
What does it involve and what do we hope to find out?
SMILE-K is a multicentre randomised controlled trial with a nested feasibility pilot and a qualitative sub-study, designed to evaluate MK&M, a digital education and self-management resource for people with non-dialysis kidney disease.
SMILE-K was delivered almost entirely online, with no in-person contact between the researchers and participants required. Outcome measures were collected by means of online surveys completed at entry to the study (baseline), 10 weeks and 20 weeks. After completion of the baseline survey, participants were randomised 2:1 to the intervention group (received the MK&M resource) or control (usual care). Control participants are given access to MK&M at the end of the study (after completion of the 20-week survey).
Eligibility criteria were:
Adult (18 years or more)
established diagnosis of chronic kidney disease and eGFR>15ml/min/1.73m2
not receiving any form of dialysis
not a kidney transplant recipient
able to give informed consent and comply with the protocol
Participants were recruited at 26 hospital sites in England, via Invitation Letter and Study Flyer provided by post, email or in person. The Participant Information Sheet, Consent Form and outcome measure surveys were accessed online.
The primary outcome measure was the Patient Activation Measure (PAM-13). A range of secondary outcomes were also collected via the online surveys, and a subset of participants were invited to qualitative interviews at baseline, 10 and 20 weeks to explore their expectations, experiences and perspectives in more depth.
Progress
Feasibility analysis was conducted on the results of the nested pilot involving the first 60 participants recruited.
SMILE-K started in late May 2021 and achieved the target recruitment of 400 in October 2022. The study closed to recruitment in December 2022 with a final recruitment of 423.
Publications from SMILE-K so far include:
The protocol for SMILE-K (open access article can be accessed here): Lightfoot CJ, Wilkinson TJ, Yates T, Davies MJ, Smith AC. ‘Self-Management Intervention through Lifestyle Education for Kidney health’ (the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study. BMJ Open. 2022;12:e064916. doi: 10.1136/bmjopen-2022-064916
The development of MK&Me (open access article can be accessed here): Lightfoot CJ, Wilkinson TJ, Hadjiconstantinou M, Graham-Brown M, Barratt J, Brough C, Burton JO, Hainsworth J, Johnson V, Martinez M, Nixon AC, Pursey V, Schreder S, Vadaszy N, Wilde L, Willingham F, Young HML, Yates T, Davies MJ, Smith AC. The Codevelopment of "My Kidneys & Me": A Digital Self-management Program for People With Chronic Kidney Disease. J Med Internet Res. 2022 Nov 14;24(11):e39657. doi: 10.2196/39657
Results
A brief plain English summary of the SMILE-K study results can be found here
Evidence
Details of the SMILE-K clinical trial can be found here.
