Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG). The S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits. Study Goals: The main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS). Secondary goals include: Assessing how smartwatch data relate to patients' quality of life and sleep patterns. Comparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength. Evaluating how well patients can use the smartwatch over the long term during home treatment. An additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear. Study Design: This is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires. Participants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly. Duration: Recruitment will last about 6 months, and each participant will be followed for 12 months. Why This Matters: By combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.
Study Type
OBSERVATIONAL
Enrollment
35
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
University Hospital Münster
Münster, North Rhine-Westphalia, Germany
Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
minimum value: 0 points, maximum value: 10 points, best result: 0 points
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: step count
Time frame: 365 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings
Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening
Time frame: 365 days
Change in Grip strength
Measured via Vigorimeter in kPa
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Medical Research Council (MRC)-Sumscore
minimum value: 0 points, maximum value: 60 points, best result: 60 points
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: approximate distance traveled (meter)
Time frame: 365 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings
Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television, Doing the dishes
Time frame: 365 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings
Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football,baseball, or tennis (singles), Playing jump rope
Time frame: 365 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Time frame: 365 days
Wearing time of smartwatch (daily)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: approximate calories burned
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Subjective occurrence of end-of-dose phenomena/wearing off
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Quality of life (QoL)
The Quality of Life Questionnaire (QoL) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas, WHOQOL-BREF (World Health Organization Quality of Life - abbreviated version)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Blood analysis (levels of sNfl, serum proteomics)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Questionnaire about smartwatch usage
Time frame: End of study visit (after 12 months, V5)
Longitudinal development of sleep parameter: time awake (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: number of times user woke up
Time frame: 365 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: WASO
Wake after sleep onset (WASO): total time asleep divided by total time in bed
Time frame: 365 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: Withings Sleep score
Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs: * Duration (total time spent sleeping) * Depth (part of night spent in restorative phases and deep sleep) * Regularity (consistency between your bed- and rise-times) * Interruptions (time spent awake)
Time frame: 365 days
Longitudinal development of cardiovascular parameter: average heartrate
Time frame: 365 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Time frame: 365 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Time frame: 365
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)
Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Time frame: 365 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)
Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Time frame: 365 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)
Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Time frame: 365 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)
Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate.
Time frame: 365 days
Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
Time frame: 365 days
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