SONG-HDF
Research type
Research Study
Full title
SONG-HD Fatigue : Validating the Core Outcome Measure
IRAS ID
258317
Contact name
Alice Smith
Contact email
Sponsor organisation
University of Leiecster
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Extreme fatigue is a common symptom suffered by patients on haemodialysis. The prevalence of this symptom can be as high as 97%, and it is believed to be unique and particularly debilitating due to the nature of treatment in this population. Despite such importance in attending to this symptom, fatigue remains under-recognised by researchers and under-treated by clinicians.
There is a plethora of instruments (questionnaires) designed to assess fatigue but all vary in terms of the target population, length, content and cost. The scores from each of these instruments may indicate something different about fatigue experienced by patients on haemodialysis. This inconsistency makes it difficult to compare the effect of interventions for fatigue in different trials.
A proposed outcome measure to be used in clinical trials involving patients on haemodialysis was designed based on shared priorities of patients, caregivers and health professionals (allied health, researchers, clinicians, policy makers and industry). This validation project will aim to provide preliminary evidence for the suitability of using the proposed outcome measure in the haemodialysis population.
Each participant will complete the proposed outcome measure and a visual analogue scale to rate the severity of their fatigue three times (once at baseline, a week later and once again two weeks after the second administration). At baseline, they will also be asked to complete either the 12-item Short Form Survey (SF-12) or the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F). Data from these surveys will be analysed to assess the following psychometric properties: test-retest reliability, responsiveness, convergent/discriminant validity, and internal consistency.This is part of an international study lead by the SONG-HD initiative : http://songinitiative.org/projects/song-hd/song-hd-fatigue/
The UK (England) study will run as a stand alone project, using the same protocol as other countries.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0427
Date of REC Opinion
24 Dec 2018
REC opinion
Favourable Opinion