Clinical trial NCT05622669: Understanding Patterns of Fatigue in Health and Disease
Official title: Understanding Patterns of Fatigue in Health and Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myeloma
Long COVID
Heart Failure
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: University of Glasgow
name: Lancaster University
name: University of Southampton
name: University College, London
First posted: 2022-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from the community and from hospital haematology and cardiology clinics

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.

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.)

Eligibility criteria: 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:

* Exclusion Criteria Applying to all participants:

  * 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
* 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.

Primary outcomes:
measure: Cognitive and physical fatigue screen (zero to ten point rating)
timeFrame: Two to four weeks (participant defined)
measure: Lived experiences of fatigue interview
timeFrame: 1 day (End of study interview)
measure: Views and opinions about the sensing technologies interview
timeFrame: 1 day (End of study interview)
measure: Views and opinions about the trial methods and study participation interview
timeFrame: 1 day (End of study interview)
Secondary outcomes:
measure: Drop-out rate
timeFrame: Participant-led study end date - two to four weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen
state: UK
Study officials:
References: