Trial document




This trial has been registered retrospectively.
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  DRKS00021693

Trial Description

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Title

Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in neurodegenerative disorders and immune-mediated inflammatory diseases, Feasibility Study

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Trial Acronym

IDEA-FAST Feasibility Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study aims to find new measures for fatigue (a feeling of tiredness/exhaustion) and sleep disturbances that are more objective, sensitive and reliable to assess the severity and impact of these symptoms on a person in their normal surrounding. The measures will be calculated from data of different new digital devices that measure behavior and physiological parameters, such as e.g. smartwatches that can measure movement. People with either Parkinson's Disease, Huntington's Disease, Inflammatory Bowel Disease, Rheumatoid Arthritis, Primary Sjögren's Syndrome or Systemic Lupus Erythematosus as well as healthy volunteers will participate in this pilot study, which explores a selection of different measures to select the most promising ones for a larger study. To this aim different combinations of devices will be worn over 4 periods of 5 days each. These technologies will be combined with frequent recordings of the person’s self-scored health states at home to get a more realistic picture of the persons health and daily life.
Such digital measures will not only help to gain insight into the underpinning mechanisms of fatigue and sleep disturbances but will also vastly improve the efficiency of clinical trials, ultimately reducing the time and cost to bring new therapies to patients.

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Brief Summary in Scientific Language

This observational study aims to identify candidate digital parameters of fatigue and sleep disturbances to be further tested in a larger study. The study population includes persons with Parkinson's Disease (target: n=18) , Huntington's Disease (target: n=18), Inflammatory Bowel Disease (target: n=18), Rheumatoid Arthritis (target: n=18), Primary Sjögren's Syndrome (target: n=18) or Systemic Lupus Erythematosus (target: n=18) as well as healthy controls (target: n=40).
Participants will be asked to report sleep disturbances and fatigue during a study period of up to 36 days, using a combination of questionnaires and an electronic short diary with visual analogue scales. Participants will be asked to fill in this electronic diary 4 times a day. During the same period, the participants will also be asked to use different combinations of digital devices/technologies over 4 periods of 5 days each.
Results of this study will inform the design of a second multi-centre clinical study investigating sleep disturbances and fatigue in a larger cohort and over a longer period, testing the validity of the most promising candidate digital endpoints identified in the pilot study.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Pseudomised data will be made available upon request after the lifetime of this project.

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Organizational Data

  •   DRKS00021693
  •   2020/08/14
  •   [---]*
  •   yes
  •   Approved
  •   D491/20, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   M05 -  Seropositive rheumatoid arthritis
  •   M06 -  Other rheumatoid arthritis
  •   M35 -  Other systemic involvement of connective tissue
  •   M32 -  Systemic lupus erythematosus
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Interventions/Observational Groups

  •   Parkinson's Disease patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
  •   Huntington's Disease patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
  •   Inflammatory Bowel Disease patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
  •   Rheumatoid Arthritis patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
  •   Primary Sjögren's Syndrome patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
  •   Systemic Lupus Erythematosus patients - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
  •   Healthy Controls - observation (includes use of different digital technologies and answering several questionnaires related to sleep, fatigue, general health, quality of life and the experience with the used technologies)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint analysis for the larger follow-up study is a comparison of candidate digital endpoints (derived from the digital technologies used) against existing clinical instruments for measuring fatigue and sleep disturbance.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   Netherlands
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2020/07/01
  •   148
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

MoCA score > 15, previous use of a smartphone for at least 3 months, diagnosis of one of the mentioned diseases or healthy volunteer, able to walk independently, to sit and stand, socialise, communicate and capable of carrying out the procedures proposed in the study, according to the opinion of the Investigator.

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Exclusion Criteria

Primary diagnosis of major sleep disorders (i.e., insomnia, obstructive sleep apnoea, central apnoea, narcolepsy and hypersomnia); Primary diagnosis of chronic fatigue syndrome; Presence of respiratory, cardiovascular, metabolic disorders or physical traumas that required hospitalization in the 3 months preceding the study enrollment or based on severity assessed by the PI as potentially interfering with the study execution; Cognitive impairment resulting in an inability to walk or to understand the intention of the project; Diagnosis of major psychiatric disorders according to DSM5 that can affect the execution of the study; Recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months; Substance or ethanol abuse that may interfere with the patient's behavior, and sleep patterns; Diagnosis of cancer within the past 3 years, except basal or squamous skin cancer, which has been adequately treated.

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Department of Neurology, UKSH Campus Kiel,
    • Mr.  Prof. Dr.  Walter  Maetzler 
    • Arnold-Heller-Str.3, Haus D
    • 24105  Kiel
    • Germany
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    • Department of Neurology, UKSH Campus Kiel
    • Ms.  Dr.  Janet  van Uem 
    • Arnold-Heller-Str.3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • IMI-JU (Europäische Kommission)
    • Avenue de la Toison d'Or 56-60
    • 1060  Brüssel
    • Belgium
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.