Finding a new way to measure fatigue in clinical studies
| ISRCTN | ISRCTN12062123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12062123 |
| IRAS number | 247550 |
| Secondary identifying numbers | IRAS 247550, CPMS 40821 |
- Submission date
- 31/07/2023
- Registration date
- 08/08/2023
- Last edited
- 14/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Fatigue is a defining feature of frailty and ageing, as well as a key factor in the loss of work productivity and impaired health-related quality of life in rheumatic and chronic disease. Current clinical measurements rely on patients’ self-assessments which are hard to quantify reproducibly. Severity fluctuates which is also difficult to capture using subjective fatigue measures. No validated objective measures of fatigue exist.
Digital devices that capture activity in the natural environment provide an indirect, objective measurement of fatigue and daily living impact. They offer readily accessible data that could reduce errors from recall bias and identify physiological response patterns. The availability of reliable objective measures will also remove a key barrier to pharmaceutical industry investment in fatigue.
This pilot study aims to explore the use of medical-grade physical activity monitors and biosensors coupled with advanced data analytics and statistical modelling to identify signatures of physical fatigue, and also to explore neuropsychological tests as objective measures of mental fatigue.
Who can participate?
Patients aged 18 years and over with primary Sjogren’s Syndrome (PSS)
What does the study involve?
Participants will wear two medical-grade devices to capture continuous physical activity, sleep data and physiological measures. This will occur over two separate 7-day periods 6-8 weeks apart. Neuropsychological tests will be carried out and confounding factors will be recorded. Subjective levels of physical and mental fatigue will be recorded three times daily via a patient diary during the 7-day observation period.
What are the possible benefits and risks of participating?
There are no direct benefits to participants but the data will be used to prepare funding applications for a larger study to find out more about the disease.
Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2018 to August 2022
Who is funding the study?
NIHR Newcastle Biomedical Research Centre (UK)
Who is the main contact?
Prof. Wan-Fai Ng, wng@ucc.ie
Contact information
Scientific, Principal Investigator
University College Cork
Cork
-
Ireland
| Phone | +353 (0)21 490 3000 |
|---|---|
| wng@ucc.ie |
Public
Rheumatology Research, Room 49 Level 1
Freeman Hospital
Newcastle upon Tyne
Newcastle upon Tyne
NE7 7DN
United Kingdom
| Phone | +44 (0)191 2137341 |
|---|---|
| victoria.macrae@newcastle.ac.uk |
Study information
| Study design | Single-centre observational pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Home, Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Develop objective assessment tools for measuring fatigue in clinical studies |
| Study acronym | TOOLS |
| Study objectives | The main objective is to identify activity patterns and associated physiological responses which correlate with self-report physical fatigue severity; and to explore whether neuropsychological performance corresponds to subjective report of mental fatigue severity. |
| Ethics approval(s) |
Approved 01/02/2019, North East - Newcastle & North Tyneside 1 REC (NHSBT Newcastle Blood Donor Centre, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)2071048084; nrescommittee.northeast-newcastleadnnorthtyneside1@nhs.net), ref: 19/NE/0002 |
| Health condition(s) or problem(s) studied | Fatigue in primary Sjogren's Syndrome |
| Intervention | This is an exploratory pilot study. There will be four visits in total for each participant. A written consent will be signed, the neurocognitive tests will be completed and the participant will be fitted with two medical-grade devices to capture; continuous physical activity/”sleep” data and other physiological measures such as; Electrocardiogram (ECG), heart rate (HR), respiratory rate (RR), skin temperature (ST). The participant will be asked to wear the device for 7 days and will be asked to complete a fatigue diary four times a day. The diary will ask the participant to record any specific activities and comments when they have experienced fatigue (open answers). It will also include the PSS-specific ESSPRI which is a validated questionnaire which considers PSS symptoms. The second visit will occur after the 7-day period of monitoring and the participant will return the devices. The participant will be asked to come back to clinic 6-8 weeks later for visit 3 to complete the study assessments and have both devices fitted for another 7-day period. The final fourth visit will take place after the 7-day monitoring period and the participant will return the devices. The following study assessments will occur at each visit: Fatigue: Fatigue will be measured using the Profile of Fatigue (PRO-F) and the Multidimensional Fatigue Inventory (MFI). Both questionnaires have separate measures for the physical and mental components of fatigue. Additionally, we will use the Cognitive Failures Questionnaire to quantify subjective cognitive symptoms. To objectively evaluate different domains of cognitive function, we will use validated neuropsychological tests including: immediate/working memory (Digit span, corsi blocks); executive functioning and attention (verbal fluency, Stroop, Trail Making Test, Vigilance/continuous performance test); psychomotor functions (Digit symbol tests) memory (Rey-Auditory Verbal Learning Test; AVLT). Other measures of fatigue include validated questionnaires; orthostatic hypotension, insomnia severity index, Epworth sleepiness scale, functional outcomes of sleep short questionnaire and the hospital and anxiety questionnaire will be used for screening. Demographics: Data will be collected on age, sex, height, and weight to assess general health. Marital status, number of children, work status and number of persons in the household will indicate the level of support available at home which could impact fatigue. Medical history will be taken to detail any co-morbidities and treatments that may have a bearing on results. Venesection: A blood sample (25 ml) will be collected at each visit. Blood samples will include 2 PAXgene RNA, 3x EDTA (1 for plasma extraction) and 1 serum. A urine sample will be collected at the beginning and end of each study period for metabolomics analysis. Biosensor devices fitted: Participants will be shown how to use the devices and fitted with the patch. VitalPatch by Vitalconnect is a disposable patch worn on the chest. It measures heart rate, respiratory rate, skin temperature, body posture, fall detection and activity (steps). It is a CE-marked Medical Device - EU Class I, FDA 510(k). ActiGraph link (Medical Device EU Class 1, FDA cleared class II) measures raw acceleration, energy expenditure, MET rates, steps taken and physical activity intensity. This device also offers continuous subject data collection. Patient diary: A diary will be provided to report fatigue four times daily. |
| Intervention type | Other |
| Primary outcome measure | Measured using biosensor data in fatigued and non-fatigued patients: 1. Physical fatigue measured using activity monitors recording; total amount of moderate to vigorous physical activity (daily/weekly), sleep (nighttime rest) efficiency, activity/inactivity bouts (number and duration), mean daily/weekly activity counts. Data collected for two 7 day periods over 8 weeks. 2. Mental fatigue measured using neuropsychological tests; immediate/working memory (Digit span, corsi blocks); executive functioning and attention (verbal fluency, Stroop, Trail Making Test, Vigilance/continuous performance test); psychomotor functions (Digit symbol tests) memory (Rey-Auditory Verbal Learning Test; AVLT). Data collected at visit 1 and visit 3. 3. Patient reported fatigue measured using a patient diary which is completed 4 times daily during the 7 day monitoring period. The Profile of Fatigue (PRO-F), the Multidimensional Fatigue Inventory (MFI) and Cognitive Failures Questionnaire are completed at the end of each monitoring period. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/05/2018 |
| Completion date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 105 |
| Key inclusion criteria | 1. Age ≥18 years 2. Fulfils the American European Consensus Group (AECG) classification criteria for primary Sjögren’s syndrome 3. Willing and able to provide informed written consent and attend clinic for visits |
| Key exclusion criteria | 1. Hospital Anxiety and Depression Score (HADS ≥11) 2. Fibromyalgia or chronic pain syndromes. 3. History of cerebrovascular diseases, dementia (mini mental state examination score 24), other central nervous system injuries/disorders that impair neurocognitive function 4. A history of severe skin allergies |
| Date of first enrolment | 15/04/2019 |
| Date of final enrolment | 12/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
Regent Point
Regent Farm Road
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)1912824926 |
|---|---|
| nuth.genericqueries@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Private sector organisation / Research institutes and centers
- Alternative name(s)
- Newcastle Biomedical Research Centre, Newcastle NIHR Biomedical Research Centre
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed scientific journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Victoria Macrae (victoria.macrae@newcastle.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | AB0799 | 19/06/2024 | 14/11/2024 | No | No |
Editorial Notes
14/11/2024: The following changes were made:
1. Results abstract linked.
2. Contact updated.
05/09/2023: Internal review.
07/08/2023: Trial's existence confirmed by North East - Newcastle & North Tyneside 1 REC.
