MyelomaFATIGUENCT05622669
Understanding Patterns of Fatigue in Health and Disease
An observational study of Myeloma and Long COVID, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myeloma, Long COVID, Heart Failure
- What is being tested?
- Observational
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2021to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from the community and from hospital haematology and cardiology clinics
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- A current or previous diagnosis of myeloma or heart failure
- Active cancer Group D, Control group
- Presence of myeloma or another active cancer, heart failure, or long COVID
- One or more chronic medical conditions which are unstable, poorly controlled, AND perceived by the individual to be causing fatigue
- Persistent or severe fatigue symptoms that are perceived by the individual to be worse than "normal tiredness"
- Taking sedating medications to manage anxiety or insomnia including but not limited to benzodiazepines or "Z" drugs, zopiclone, zolpidem, and others in this British National Formulary Class.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Fatigue can be the most disabling symptom experienced by patients with a wide range of diseases. In primary care, it is very challenging for clinicians to differentiate between physiological fatigue (i.e., "normal" tiredness associated with lifestyle factors) and fatigue caused by underlying pathology such as heart disease or cancer. Treatment of persistent fatigue is usually by trial-and-error without attention to personalized triggers or disparate fatigue mechanisms.
This feasibility study will investigate patient experiences of fatigue in depth, combining objective measures of sensed physiological parameters with patient reports and validated patient reported outcome measures. Patients will be recruited with three distinct clinical conditions: myeloma; long COVID; and heart failure. A healthy control group will also be recruited.
Participants will participate in a feasibility study with a longitudinal, Ecological Momentary Assessment (EMA) design, wearing sensors, and providing four times daily short self-reports of fatigue over a two-to-four week period (to be determined by the individual participant and their preferences and patterns of fatigue). They will complete validated fatigue, affect, and interoceptive awareness scores at baseline and at two weeks and participate in end of study telephone interviews with a Research Assistant.
Sensors will measure objective parameters including activity levels; heart rate; sleep; and posture (sitting/standing). Additional sensors ("beacons") will measure participant's movements and positioning within their own environment (position relative to the beacons - beacon location to be determined by participant placement); environmental temperature; noise and light levels.
Data will be analysed using multilevel modelling and Machine Learning to detect patterns in the fatigue experiences and to compare fatigue measurements within individuals; between individuals with the same clinical condition; and between groups of individuals with different clinical conditions/controls.
This feasibility study will provide data that helps to determine:
- The utility and usefulness of different sensed parameters in understanding the fatigue experience
- The practicality and acceptability of collecting the proposed sensed and self-reported data and recruitment and retention rates (to inform a larger study)
- Whether there might be meaningful differences in fatigue between individuals and groups of individuals with distinct medical conditions
- Whether there is scope for a larger study into clinical "phenotypes" of fatigue (distinct classes of fatigue that might vary according to different combinations of physiological signatures, different patient descriptions/language used to describe the experience, diurnal variation, etc.)
- Conditions
- Myeloma, Long COVID, Heart Failure
- Being tested
- Observational
- Medical subject headings
- Neoplasms, Plasma Cell, Post-Acute COVID-19 Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Sensed and lived experience data from all groups without a specific behavioural or drug intervention
| Study group | Role | What they receive |
|---|---|---|
| Myeloma | Individuals experiencing fatigue related to myeloma or its treatment Receives: Other: Observational | |
| Long COVID | Individuals experiencing fatigue related to Long COVID Receives: Other: Observational | |
| Heart failure | Individuals experiencing fatigue related to heart failure or its treatment Receives: Other: Observational | |
| Controls | Individuals who are not experiencing problematic fatigue and who do not have myeloma, long COVID, or heart failure Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day (End of study interview)
Secondary outcomes (1)
Drop-out rate
The proportion of participants who drop out of the study before the end of study interview
Measured: Participant-led study end date - two to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start7 Dec 2021
- Primary completion18 Dec 2023
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Glasgow, Lancaster University, University of Southampton, University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622669
- Sponsor's protocol ID
- 2-090-22
- Acronym
- FATIGUE
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38802273
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patterns of Fatigue in Health and Disease
- ClinicalTrials.gov ID
- NCT05622669
- Acronym / sponsor ID
- FATIGUE / 2-090-22
- Conditions
- Myeloma, Long COVID, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Glasgow, Lancaster University, University of Southampton, University College, London
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fatigue can be the most disabling symptom experienced by patients with a wide range of diseases. In primary care, it is very challenging for clinicians to differentiate between physiological fatigue (i.e., "normal" tiredness associated with lifestyle factors) and fatigue caused by underlying pathology such as heart disease or cancer. Treatment of persistent fatigue is usually by trial-and-error without attention to personalized triggers or disparate fatigue mechanisms.
This feasibility study will investigate patient experiences of fatigue in depth, combining objective measures of sensed physiological parameters with patient reports and validated patient reported outcome measures. Patients will be recruited with three distinct clinical conditions: myeloma; long COVID; and heart failure. A healthy control group will also be recruited.
Participants will participate in a feasibility study with a longitudinal, Ecological Momentary Assessment (EMA) design, wearing sensors, and providing four times daily short self-reports of fatigue over a two-to-four week period (to be determined by the individual participant and their preferences and patterns of fatigue). They will complete validated fatigue, affect, and interoceptive awareness scores at baseline and at two weeks and participate in end of study telephone interviews with a Research Assistant.
Sensors will measure objective parameters including activity levels; heart rate; sleep; and posture (sitting/standing). Additional sensors ("beacons") will measure participant's movements and positioning within their own environment (position relative to the beacons - beacon location to be determined by participant placement); environmental temperature; noise and light levels.
Data will be analysed using multilevel modelling and Machine Learning to detect patterns in the fatigue experiences and to compare fatigue measurements within individuals; between individuals with the same clinical condition; and between groups of individuals with different clinical conditions/controls.
This feasibility study will provide data that helps to determine:
- The utility and usefulness of different sensed parameters in understanding the fatigue experience
- The practicality and acceptability of collecting the proposed sensed and self-reported data and recruitment and retention rates (to inform a larger study)
- Whether there might be meaningful differences in fatigue between individuals and groups of individuals with distinct medical conditions
- Whether there is scope for a larger study into clinical "phenotypes" of fatigue (distinct classes of fatigue that might vary according to different combinations of physiological signatures, different patient descriptions/language used to describe the experience, diurnal variation, etc.)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myeloma | – | Other: ObservationalIndividuals experiencing fatigue related to myeloma or its treatment |
| Long COVID | – | Other: ObservationalIndividuals experiencing fatigue related to Long COVID |
| Heart failure | – | Other: ObservationalIndividuals experiencing fatigue related to heart failure or its treatment |
| Controls | – | Other: ObservationalIndividuals who are not experiencing problematic fatigue and who do not have myeloma, long COVID, or heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the community and from hospital haematology and cardiology clinics
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalSensed and lived experience data from all groups without a specific behavioural or drug intervention | Other | Controls, Heart failure, Long COVID, Myeloma |
Primary outcome
Cognitive and physical fatigue screen (zero to ten point rating)
Time frame: Two to four weeks (participant defined)
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)
Lived experiences of fatigue interview
Time frame: 1 day (End of study interview)
Qualitative data collected by an end of study interview according to a topic schedule
Views and opinions about the sensing technologies interview
Time frame: 1 day (End of study interview)
Qualitative data collected by an end of study interview according to a topic schedule
Views and opinions about the trial methods and study participation interview
Time frame: 1 day (End of study interview)
Qualitative data collected by an end of study interview according to a topic schedule
1 secondary outcome
Drop-out rate
Time frame: Participant-led study end date - two to four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 38802273Adam 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma and Long COVID, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive and physical fatigue screen (zero to ten point rating) (time frame: Two to four weeks (participant defined)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05622669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.