Patient information

For patients with chronic diseases such as neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID), a key attribute for any successful therapeutic intervention is its ability to improve the patients’ activities of daily living (ADL) and health-related quality of life (HRQoL). Current evaluations of ADL and HRQoL rely mainly on subjective reports, typically using standardized questionnaires provided by patients every few months. The approach is often prone to recall bias, reliability issues and poor sensitivity to change. IDEA-FAST wants to change this!

The goal is to identify, profile and validate digital solutions based on mobile or residential technology for remote assessment of fatigue and sleep disturbances that could effectively be used as digital endpoints in assessments for RA, SLE, PSS, IBD, PD, HD and beyond. Identifying digital endpoints for fatigue and sleep disturbances that can be used in patients’ usual living environment will also enable the meaningful evaluation of impacts of these symptoms on ADL/HRQoL. The ecological validity of these digital endpoints will be tested using a large longitudinal cohort of four IMID and two NDD.

Conditions

PD

Parkinson's Disease

A gradual onset progressive degenerative disease whose cardinal manifestations include bradykinesia plus one of the following - tremor, rigidity or postural instability. Nonmotor manifestations: autonomic dysfunction, neuropsychiatric features.

HD

Huntington's Disease

A rare neurodegenerative disorder of the central nervous system. HD is an autosomal dominant disorder due to a t-mutation resulting in an increased number of triplicate cytosine-adenine-guanine repeats on chromosome 4. The manifestations include chorea, dementia and personality changes. In the Westphal variant dystonia and parkinsonism are prominent.

RA

Rheumatoid Arthritis

Persistent and/or erosive disease defined as the confirmed presence of synovitis in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) in 4 domains: number and site of involved joints, serologic abnormality, elevated acute-phase response, symptom duration.

SLE

Systemic Lupus Erythematosus

An autoimmune non-organ specific inflammatory disease characterised by the presence of antibodies to DNA, RNA and other components of the nucleus. Variable clinical presentation and course ranging from an acute fulminant life-threatening disorder with involvement of heart, central nervous system and kidneys to an indolent chronic scarring skin disorder.

PSS

Primary Sjogren’s Syndrome

A slowly progressive, systemic inflammatory autoimmune disease affecting primarily the exocrine glands. Lymphocytic infiltrates replace functional epithelium, leading to oral and ocular dryness. Characteristic autoantibodies (e.g., anti-Ro/SS-A and/or anti-La/SS-B) are produced.

IBD

Inflammatory Bowel Disease

A group of inflammatory conditions of the intestine of unknown etiology. The pathogenesis is hypothesized that the mucosal immune system shows an aberrant response towards luminal antigens such as dietary factors and commensal microbiota in genetically susceptible individuals.

Goals

Identify and select a set of digital endpoints and corresponding digital devices/technologies
Build a digital management platform
Establish a large and well-characterised longitudinal cohort of patients
Run a (1) feasibility and (2) clinical validation study
Receive scientific advice from EMA for the future use of digital endpoints in clinical trials

Impact

Identify and select a set of digital endpoints and corresponding digital devices/technologies
Build a digital management platform
Establish a large and well-characterised longitudinal cohort of patients
Run a (1) feasibility and (2) clinical validation study
Receive scientific advice from EMA for the future use of digital endpoints in clinical trials

How to participate

Are you eligible for the study?

Before you contact the study sites, please make sure to check the eligibility criteria. Our dedicated researchers will screen every participant before enrolling, but below you can find a checklist to see if you could be a good fit. Please also check again the target conditions.

Yes

You are of legal age (18 years or older).
You are willing to use a few (2-4) digital devices over one year. Previous use of a smartphone for at least 3 months would be beneficial.
Your diagnosis of Parkinson’s Disease/ Huntington’s Disease / Crohn’s Disease, Ulcerative Colitis/ Rheumatoid Arthritis/ Primary Sjögren’s Syndrome/ Systemic Lupus Erythematosus has been confirmed by a doctor according to current medical guidelines.
For Huntington’s Disease, people who have undergone genetic testing with a positive result (CGA rep ≥40) but do not show symptoms, can also be considered.
You are able to walk independently, to sit and stand, socialise, communicate and understand oral and/or written instructions in relation to the study.
Consent to the use of your contact data in the context of the clinical validation study, so we can contact you once the study will start.

No

You have a primary diagnosis (not related to your other disease) of a major sleep disorders (i.e., insomnia, obstructive sleep apnoea, central apnoea, narcolepsy and hypersomnia) or chronic fatigue syndrome.
You have a severe cognitive impairment, which prevents you from understanding the intention of the project.
Your disease started in childhood/adolescence (<16 years).
You have been diagnosed with a major psychiatric disorder according to DSM5 that can affect the execution of the study or have tried to take your own life within the last five years.
You suffer from addiction (substance or alcohol abuse), which may interfere with your behavior, and sleep patterns.
You have been diagnosed with cancer within the past 3 years. Exception: Basal or squamous skin cancer, which has been adequately treated or remote cancers, which are in remission, and do not impact your ability to participate in this study.