Evaluation of the Warwick Axial Spondyloarthritis Fatigue and Energy questionnaire (e-WASTEd)) in rheumatology clinical practice.
| ISRCTN | ISRCTN64318436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64318436 |
| IRAS number | 310098 |
| Secondary identifying numbers | IRAS 310098, CPMS 53089, IDEATE 69591 |
- Submission date
- 18/09/2023
- Registration date
- 19/10/2023
- Last edited
- 01/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Axial Spondyloarthritis (axSpA) is relatively common, affecting 3 in every 1,000 UK adults. There is no cure. Pain, stiffness, reduced mobility, and severe fatigue are important problems. Patients have said that they would like more help coping with fatigue. However, the current way patients are asked about fatigue can undervalue its importance and impact. The study team worked with patients to complete the first steps towards making a new questionnaire to assess fatigue. However, this work needs to be completed before it can be used in clinical practice. This study aims to work with patients to refine and test this new questionnaire about fatigue in axSpA to help patients tell clinicians about their fatigue and get the treatment they need. An online version will be made which will be completed using a computer or tablet. Guidance will be provided to improve the use of online questionnaires.
Who can participate?
People aged 18 years old and over with axSpA
What does the study involve?
A new online system is being used by NHS clinicians to support questionnaire completion by rheumatology patients. The system will be used to test the study questionnaire and to find out what patients and clinicians think about it. For example, its ease of use and whether it helps in meetings between patients and clinicians. This will help the study team both to improve the system and ultimately improve patient care.
What are the possible benefits and risks of participating?
Participants may benefit from being able to track several aspects of their health over the course of the study. There are no risks to participation.
Where is the study run from?
The University of Warwick (UK)
When is the study starting and how long is it expected to run for?
August 2022 to July 2024
Who is funding the study?
The National Institute for Health and Care Research (NIHR) through the Research for Patient Benefit (RfPB) Programme (UK)
Who is the main contact?
Prof Kirstie Haywood, k.l.haywood@warwick.ac.uk
Contact information
Principal Investigator
Warwick Research in Nursing
Division of Health Sciences
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0002-5405-187X |
|---|---|
| Phone | +44 (0)7972374204 |
| k.l.haywood@warwick.ac.uk |
Study information
| Study design | Multicentre longitudinal mixed methods study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Internet/virtual |
| Study type | Diagnostic, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Measuring fatigue in Axial Spondyloarthritis (axSpA): refinement, application and evaluation of a new electronic patient-reported outcome measure (the Warwick Axial Spondyloarthritis Fatigue and Energy questionnaire (e-WASTEd)) in rheumatology clinical practice. |
| Study acronym | WASTEd |
| Study hypothesis | The electronic version of the WASTEd PROM is a reliable and valid method to identify fatigue and energy levels in patients with axial spondyloarthritis |
| Ethics approval(s) |
Approved 08/12/2022, Preston Research Ethics Committee (HRA NRES Centre, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8364; preston.rec@hra.nhs.uk), ref: 22/NW/0211 |
| Condition | Axial spondyloarthritis |
| Intervention | Stage 1: Refining the WASTEd-Short Form 1.1. Qualitative interviews (paper version of WASTEd): Three rounds of semi-structured interviews (online/by phone) with people with axial spondyloarthritis, providing the first opportunity to check the content and face validity of the ‘short-form’ 18-item WASTEd. 1.2. Develop the e-WASTEd: We will create an electronic (e) version which is compatible with online completion using computers and tablets via the British Society of Rheumatology's (BSR) electronic patient-reported outcome measure (ePROM) platform. We will not change the PROM item structure or content. 1.3. Pilot the e-WASTEd - qualitative interviews: We will conduct up to 10 semi-structured interviews (online/phone) to check the usability, acceptability, and feasibility of the eWASTEd. Stage 2: Evaluating the e-WASTEd: A cohort of people with axial spondyloarthritis (n=380) will complete a suite of ePROMs at baseline and follow-ups at week 2 and month 3. The principle ePROM of interest is the Warwick Axial Spondyloarthritis Fatigue and Energy questionnaire (e-WASTEd)). Stage 3: Exploring the experiences of patients and clinicians using the BSR ePROM platform To explore patient and clinician experiences of using ePROMs accessed via the ePROM platform to provide information to help to improve the ePROM platform and ultimately to improve patient care. We estimate requiring up to 10 patients and 10 health professionals (clinicians, physiotherapists, nurses) to participate in focus groups. Note: The WASTEd is currently only available in the English language, so the ability to understand written English is a study requirement. The WASTEd has a readability level of 11-13 years; hence, patients with significantly limited literacy levels are excluded. This extends to patients with significant co-morbidities. |
| Intervention type | Mixed |
| Primary outcome measure | Fatigue and energy measured using the WASTEd 18-item questionniare at baseline, 2-week and 3-month follow-up |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline, 2-week and 3-month follow-up: 1. Health-related quality of life measured using the EQ-5D five questionnaire descriptive system and the EQ visual analogue scale (EQ VAS) 2. Self-reported fatigue and its impact upon daily activities and function measured using the Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue) 5-point Likert-type scale comprising 13 items 3. Anxiety and depression symptoms measured using the Hospital Anxiety and Depression Score (HADS) 4-point Likert-type scale comprising 14 items 4. Pain measured using a single measure of pain severity using an 11-point numerical rating scale 5. Four domains of physical function, disease activity, emotional well-being and social participation measured using the Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL) 5-point Likert-type scale comprising 20 items 6. Functional and disease activity indices measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) comprising a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions 7. Functional anatomical limitations due to the course of this inflammatory disease and the patient’s ability to cope with everyday life measured using the Bath Ankylosing Spondylitis Functional Index (BASFI) comprising 10 VAS questions |
| Overall study start date | 01/08/2022 |
| Overall study end date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 411 |
| Total final enrolment | 272 |
| Participant inclusion criteria | Patients: 1. Adults aged 18 years old and over 2. A confirmed diagnosis of axSpA 3. Registered with participating rheumatology centres 4. Access to a computer or tablet device to allow for receipt of the e-mail and e-WASTEd completion Health professionals: Experience of using the BSR ePROM portal with their patients |
| Participant exclusion criteria | 1. Ability to understand written English to a readability level of 11-13 years 2. Patients with significant co-morbidities |
| Recruitment start date | 26/09/2022 |
| Recruitment end date | 30/04/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Stoke-on-trent
ST6 7AG
United Kingdom
Glasgow
G12 0YN
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Gwenfro Units
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom
Sarn Lane
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Unit 15 Gwenfro
Wrexham
LL13 7YP
United Kingdom
Bath
BA1 3NG
United Kingdom
Sponsor information
University/education
Research & Impact Services
University House
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 024 765 75732 |
|---|---|
| Karen.Julian@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Interview data from stages 1 & 3 will not be made available. The dataset generated during stage 3 is not expected to be made available as this data is held by the British Society of Rheumatology within their ePROM portal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.5 | 07/06/2023 | 10/10/2023 | No | No |
Additional files
Editorial Notes
01/08/2024: Total final enrolment added. The intention to publish date was changed from 01/07/2024 to 01/02/2025.
10/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
