"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

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/1.73m2) 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 2:1 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ISRCTN18314195

Funding Statement

This study is funded by the Stoneygate Trust and the Leicester NIHR Biomedical Research Centre. All PPIE activities were supported by two grants from the Leicester Kidney Care Appeal awarded to TJW and ACS. Funders had no input into study protocol.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

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.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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