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NCT05622669Befejeződött

Understanding Patterns of Fatigue in Health and Disease

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 31.

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Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
40 (tényleges)
Első benyújtás
2022. nov. 3.
Kezdés
2021. dec. 7.
Elsődleges befejezés
2023. dec. 18.
Fő szponzor
University of Aberdeen
NCT-szám
NCT05622669

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 40
  • 2021. dec. 7. és az elsődleges befejezés (2023. dec. 18.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Current or previous diagnosis of heart failure or long COVID
  • A current or previous diagnosis of myeloma or long COVID
  • A current or previous diagnosis of myeloma or heart failure
  • 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.

Más betegség

  • An active primary cancer diagnosis other than myeloma Group B Heart Failure
  • Active cancer Group C, long COVID
  • 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

Életkor

  • 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

Egyéb

  • Uncontrolled hypercalcaemia
  • Persistent or severe fatigue symptoms that are perceived by the individual to be worse than "normal tiredness"

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
University of AberdeenAberdeenEgyesült KirályságIsmeretlen állapot

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