This study is part of an important international collaboration called Standardised Outcomes in Nephrology (SONG):

The SONG-HD Fatigue study was led by Professor Allison Tonge and Dr Angela Ju from Sydney Australia. It was carried out in a number of different countries across the globe.

Leicester is the lead site for the UK and the Chief Investigator is Professor Alice Smith, head of the Leicester Kidney Lifestyle Team. Participants were recruited from 7 UK sites: Leicester, Nottingham, Derby, Preston, Salford, Sheffield and Mid Essex.

What was the purpose of the study?

Fatigue is a common symptom that is associated with cardiovascular events, mortality and decreased quality of life in patients on haemodialysis (HD). The prevalence of this symptom is as high as 97%, and despite this, fatigue remains under-recognised by researchers and under-treated by clinicians. There is no standardised measure of fatigue for researchers to use in the HD population, and consequently fatigue is measured infrequently, inconsistently, and using measures that are not sufficiently validated. Furthermore, the heterogeneity and inconsistency of measures reported for fatigue makes it difficult to compare the effect of interventions across trials. This study will validate a new outcome measure (questionnaire) to assess fatigue in patients on HD. The questionnaire was designed based on shared priorities of patients, caregivers, and health professionals.

Progress

The study opened in the UK in February 2019 and closed to recruitment at the end of June 2019. In this 5 month period we recruited a total of 312 UK participants, which represents 70% of the global total. We are proud of this success which reflects well on the UK kidney community and the Leicester team in particular, demonstrating our outstanding ability to deliver clinical research trials efficiently and effectively. Output from this project will form the preliminary evidence required for other researchers to start using the proposed outcome measure with confidence. Validation data will grow as more people use the measure in various clinical trials.

Evidence

Publications from the SONG-HD Fatigue study can be viewed here.