Improving self-management behaviour through a digital lifestyle intervention: An internal pilot study

Courtney J Lightfoot; Thomas J Wilkinson; Noemi Vadaszy; Matthew P M Graham-Brown; Melanie J Davies; Thomas Yates; Alice C Smith

doi:10.1111/jorc.12488

Improving self-management behaviour through a digital lifestyle intervention: An internal pilot study

J Ren Care. 2024 Jan 31. doi: 10.1111/jorc.12488. Online ahead of print.

Authors

Courtney J Lightfoot^{1

2}, Thomas J Wilkinson^{1

2

3}, Noemi Vadaszy^{1

2}, Matthew P M Graham-Brown^{2

4

5}, Melanie J Davies^{2

3}, Thomas Yates^{2

3}, Alice C Smith^{1

2}

Affiliations

¹ Leicester Kidney Lifestyle Team, Department of Population Health Sciences, University of Leicester, Leicester, UK.
² NIHR Leicester Biomedical Research Centre, Leicester, UK.
³ Diabetes Research Centre, University of Leicester, Leicester, UK.
⁴ Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
⁵ Department of Renal Medicine, University Hospitals of Leicester NHS Trust, Leicester, UK.

PMID: 38296833
DOI: 10.1111/jorc.12488

Abstract

Background: Self-management is a key component of successful chronic kidney disease (CKD) management. Here, we present the findings from the internal pilot of a multicentre randomised controlled trial (RCT) aimed to test the effect of a digital self-management programme ('My Kidneys & Me' (MK&M)).

Methods: Participants (aged ≥18 years and CKD stages 3-4) were recruited from hospital kidney services across England. Study processes were completed virtually. Participants were randomised 2:1 to either intervention (MK&M) or control group. The first 60 participants recruited were included in a 10-week internal pilot which assessed study feasibility and acceptability against pre-specified progression criteria: 1) eligibility and recruitment, acceptability of 2) randomisation and 3) outcomes, 4) MK&M activation, and 5) retention and attrition rates. Semi-structured interviews further explored views on trial participation.

Results: Of the 60 participants recruited, 41 were randomised to MK&M and 19 to control. All participants completed baseline measures and 62% (n=37) completed post-intervention outcome measures. All progression criteria met the minimum thresholds to proceed. Nine participants were interviewed. The themes identified were satisfaction with study recruitment processes (openness to participate, reading and agreeing to "terms and conditions"), acceptability of study design (remote study participation, acceptability of randomisation, completion of online assessment(s)), and methods to improve recruitment and retention (personalised approach, follow-up communication).

Conclusion: This internal pilot demonstrated the feasibility and acceptability of a virtually run RCT. Progression criteria thresholds to proceed to the definitive RCT were met. Areas for improvement were identified and protocol amendments were made to improve trial delivery.

Keywords: chronic kidney disease; digital health; digital health intervention; patient activation; self-management.

Abstract

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