‘Self-Management Intervention through Lifestyle Education for Kidney health’ (the SMILE-K study): protocol for a single-blind longitudinal randomised control trial with nested pilot study (preprint)

ABSTRACT

ABSTRACT Introduction Many people living with chronic kidney disease (CKD) are expected to self-manage their condition. Patient activation is the term given to describe the knowledge, skills, and confidence a person has in managing their own health and is closely related to the engagement in preventive health behaviors. Self-management interventions have the potential to improve remote disease management and health outcomes. We are testing an evidence- and theory-based digital self-management structured 10-week programme developed for CKD patients called ‘My Kidneys & Me’. The primary aim of the study (SMILE-K) is to assess the effect on patient activation levels. Methods and analysis A single-blind randomised control trial (RCT) with a nested pilot study will assess the feasibility of the intervention and study design before continuation to a full RCT. Individuals aged 18 years or older, with established CKD stage 3-4 (eGFR of 15-59 ml/min/1.73m 2 ) will be recruited through both primary and secondary care pathways. Participants will be randomised into two groups intervention group and control group. The primary outcome is the Patient Activation Measure (PAM-13). The full RCT will assess the effect of the programme on online self-reported outcomes which will be assessed at baseline, after 10-weeks, and then after 20-weeks in both groups. A total sample size of n=432 participants are required based on a 21 randomisation. A sub-study will measure physiological changes (e.g., muscle mass, physical function) and patient experience (qualitative semi-structured interviews). Ethics and dissemination This study was fully approved by the Research Ethics Committee-Leicester South on the 19/11/2020 (reference 17/EM/0357). All participants are required to provide informed consent obtained online. The results are expected to be published in scientific journals and presented at clinical research conferences. This is protocol version 1.0 dated 27/01/2021. Trial registration number The study was prospectively registered as ISRCTN18314195 in December 2020.