Understanding Patterns of Fatigue in Health and Disease
FATIGUE
1 other identifier
observational
40
1 country
1
Brief Summary
Fatigue is a common symptom and can be the most distressing symptom of a range of medical conditions. This Ecological Momentary Assessment study will investigate lived experiences of fatigue in detail in individuals with myeloma, long COVID, heart failure, and in healthy controls without fatigue. Participants will wear ECG patches and wrist-worn sensors that measure heart rate variability, activity levels, posture, and other parameters. They will self-rate their levels of fatigue four times daily and on-demand (when fatigue levels are noticeably good or troublesome). They will participate in an end of study interview and will have an optional feedback session with a researcher to make sense of the data they have provided.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2021
CompletedFirst Submitted
Initial submission to the registry
November 3, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedApril 5, 2024
February 1, 2024
2 years
November 3, 2022
April 3, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Cognitive and physical fatigue screen (zero to ten point rating)
Fatigue screen based on "state" items from the validated Mental and Physical State and Trait Energy and Fatigue Scale (O'Connor P. University of Georgia; 2006). Participants will self-report their fatigue at that moment (split into physical and cognitive/mental fatigue) on a 0-10 point numerical rating scale, anchored with "I feel no fatigue" = 0 and "strongest feeling of fatigue ever" = 10. Participants will be prompted to respond via an app four times daily and can also provide on-demand ratings when their fatigue levels are particularly problematic or when they are not experiencing problematic fatigue. Multilevel modelling will be conducted to identify changes in fatigue over time and to explore the relationships between self-reported fatigue scores and sleep, activity levels (step-count, posture, measured by wrist worn sensor), respiratory rate (measured by ECG patch), and heart rate variability (measured by ECG patch)
Two to four weeks (participant defined)
Lived experiences of fatigue interview
Qualitative data collected by an end of study interview according to a topic schedule
1 day (End of study interview)
Views and opinions about the sensing technologies interview
Qualitative data collected by an end of study interview according to a topic schedule
1 day (End of study interview)
Views and opinions about the trial methods and study participation interview
Qualitative data collected by an end of study interview according to a topic schedule
1 day (End of study interview)
Secondary Outcomes (1)
Drop-out rate
Participant-led study end date - two to four weeks
Study Arms (4)
Myeloma
Individuals experiencing fatigue related to myeloma or its treatment
Long COVID
Individuals experiencing fatigue related to Long COVID
Heart failure
Individuals experiencing fatigue related to heart failure or its treatment
Controls
Individuals who are not experiencing problematic fatigue and who do not have myeloma, long COVID, or heart failure
Interventions
Sensed and lived experience data from all groups without a specific behavioural or drug intervention
Eligibility Criteria
Participants will be selected from the community and from hospital haematology and cardiology clinics
You may qualify if:
- For all groups, participants will be included if they are willing to participate in intermittent ecological momentary assessments of fatigue, to wear an ECG patch, to provide questionnaire responses at baseline, and the end of the study, and to participate in an end of study interview.
- A confirmed diagnosis of myeloma
- Has experienced fatigue that is perceived by the participant to be worse than "normal tiredness" and that they associate with myeloma or treatment for myeloma
- A formal diagnosis of heart failure
- All stages of heart failure and all aetiologies and with no specific ejection fraction cut-off
- Has experienced fatigue that is perceived by the participant to be worse than "normal tiredness" and that they associate with their cardiac disease or its treatment
- Experiencing fatigue that is perceived by the participant to be worse than "normal tiredness", with or without other physical or psychological symptoms that developed during or after an infection consistent with COVID-19
- The fatigue (plus or minus any other symptoms) has continued for greater or equal to 12 weeks, and is not explained by an alternative diagnosis
- Individuals aged 18 years or over without the disease conditions specified in Groups A to C
You may not qualify if:
- Difficulty communicating in English
- Adults lacking capacity to consent
- Under 18 years of age
- Declines to participate
- Under investigation for or starting treatment for an endocrine, metabolic, or thyroid condition where the participant has not been established on a stable therapeutic dose of a licensed therapy for that condition
- A confirmed diagnosis of sleep apnoea or narcolepsy
- HADs depression and anxiety score at baseline greater than 8 on the depression questions, which might indicate untreated or undertreated depression
- Shift work that involves overnight working between the hours of 9pm and 9am
- We will not exclude patient participants in groups A to C based on the type of prescribed medications that they are taking. Instead, this will be carefully documented.
- For Group A, myeloma
- Uncontrolled hypercalcaemia
- Current or previous diagnosis of heart failure or long COVID
- An active primary cancer diagnosis other than myeloma Group B Heart Failure
- A current or previous diagnosis of myeloma or long COVID
- Active cancer Group C, long COVID
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- University of Cambridgecollaborator
- University of Glasgowcollaborator
- Lancaster Universitycollaborator
- University of Southamptoncollaborator
- University College, Londoncollaborator
Study Sites (1)
University of Aberdeen
Aberdeen, UK, AB25 2ZD, United Kingdom
Related Publications (1)
Adam R, Lotankar Y, Sas C, Powell D, Martinez V, Green S, Cooper J, Bradbury K, Sive J, Hill DL. Understanding patterns of fatigue in health and disease: protocol for an ecological momentary assessment study using digital technologies. BMJ Open. 2024 May 27;14(5):e081416. doi: 10.1136/bmjopen-2023-081416.
PMID: 38802273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2022
First Posted
November 18, 2022
Study Start
December 7, 2021
Primary Completion
December 18, 2023
Study Completion
March 30, 2024
Last Updated
April 5, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data sharing will start in December 2022 and data sharing may continue until the end of the retention period for research data generated by the study (current retention period 20 years).
- Access Criteria
- Party to the project data sharing agreement Use approved by Research Ethics Committee.
This project has put in place a data sharing plan in accordance with the International Committee of Medical Journal Editors (ICMJE), as published in Annals.org on 6 June 2017. Data will be shared with investigators whose proposed use of the data has been approved by the Research Ethics Committee and who are parties to the project data sharing agreement for the purposes of conducting analyses to achieve the aims in the approved protocol. The data will be made available as pseudonymised data shared using a University of Aberdeen approved data sharing platform.