UnknownNot Applicable

Understanding Patterns of Fatigue in Health and Disease

United Kingdom40 participantsStarted 2021-12-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Inclusion Criteria for Group A, individuals with myeloma * 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 Inclusion Criteria for Group B, heart failure * 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 Inclusion Criteria for Group C, long COVID * 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 Inclusion criteria for Group D, control group • Individuals aged 18 years or over without the disease conditions specified in Groups A to C Exclusion Criteria: * Exclu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive and physical fatigue screen (zero to ten point rating)

Timeframe: Two to four weeks (participant defined)

Lived experiences of fatigue interview

Timeframe: 1 day (End of study interview)

Views and opinions about the sensing technologies interview

Timeframe: 1 day (End of study interview)

Views and opinions about the trial methods and study participation interview

Timeframe: 1 day (End of study interview)

Trial details

NCT IDNCT05622669

SponsorUniversity of Aberdeen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-18

View on ClinicalTrials.gov More Myeloma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cognitive and physical fatigue screen (zero to ten point rating)

Timeframe: Two to four weeks (participant defined)

Lived experiences of fatigue interview

Timeframe: 1 day (End of study interview)

Views and opinions about the sensing technologies interview

Timeframe: 1 day (End of study interview)

Views and opinions about the trial methods and study participation interview

Timeframe: 1 day (End of study interview)