SMILE-K
Research type
Research Study
Full title
A pilot feasibility study of an online Self-Management Intervention through Lifestyle Education for Kidney health (SMILE-K)
IRAS ID
282573
Contact name
Alice Smith
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN18314195
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Research Summary
People living with kidney problems (or chronic kidney disease (CKD)) need to look after their own health until they reach the need for dialysis or a kidney transplant, which most patients will never require. Having a healthy lifestyle can help people with CKD live a good quality of life and potentially slow disease progression. However, many people with CKD do not know about their condition, its treatment, or how to look after their health. To manage health effectively, patients need to have the knowledge, confidence and skills to take on this role.
We have developed an online educational programme aiming to improve CKD patients’ knowledge, confidence and skills to look after their own health. This study aims to test how feasible this online programme is, and if this can be studied in a larger trial. The study is divided into two parts: Part A and Part B.
Part A is the main trial, where patients will be randomly allocated into either a group receiving access to the programme, or a control group who will not receive the programme until the end. We will assess how many people are recruited, if patients follow the programme as intended, how many people in both groups drop out, if people fill in the questionnaires as intended and safety. This part of the study is run online.
Part B is split into two smaller studies; each includes a small sample of those taking part in Part A. Part B1 is a visit to the hospital to assess the participant's physical abilities before and after the programme. Part B2 is an interview (either in person or over the phone) with a researcher, firstly to explore patients management of their condition, thoughts of the programme and how they found taking part (if in intervention group).
Summary of Results
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REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0252
Date of REC Opinion
16 Nov 2020
REC opinion
Further Information Favourable Opinion