A Prospective Study to Evaluate the Usefulness of Electronically Captured Wearable Data to Assess Disease Activity in CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) Patients Undergoing IVIG (Intravenous Immunoglobulin) Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Longitudinal development of activity parameter: sum of all active time (seconds)
研究概览
简要总结
This clinical, prospective study aims to evaluate the usefulness of electronically captured wearable data to assess disease activity in CIDP (chronic inflammatory demyelinating polyneuropathy) patients undergoing IVIG treatment. Close clinical monitoring will complement smartwatch-acquired data to shed light on different patient clusters and end-of-dose phenomena.
详细描述
CIDP is a rare chronic neurological condition that leads to a considerable patient burden. As symptoms are often challenging to monitor, finding an individually optimal treatment regimen can be challenging. Additionally, patients receiving treatment often describe individual end-of-dose-phenomena, frequently leading to uncertainty regarding treatment intervals. Digital smartwatch-based measurements could add high-frequency real-world data to the picture and thus improve the understanding of individual disease courses.
Consequently, this study aims to evaluate different digital measurements and blood-based analyses to monitor disease activity in CIDP patients treated with intravenous immunoglobulins. Firstly, digital and blood-based measures will be compared to subjective patient reports and established clinical scores. Secondly, explorative analyses will aim to understand the longitudinal disease course and fluctuations thereof.
Data captured by the used smartwatches (Withings Scanwatch) includes activity-related data (step count, minutes in certain intensity levels), basic cardiovascular measurements such as heart rate, and sleep-related data (total time asleep, sleep quality, etc.). Blood-based measurements include serum neurofilament-light-chain (sNfL), glial fibrillary acidic protein (GFAP) and proteomic data. The investigators aim is to show can show whether therapy-dependent activity patterns, such as the end-of-dose phenomenon, are reflected in the recorded data.
Optionally, the digital signatures of CIDP patients will be compared to these of healthy controls wearing the smartwatch.
Patients were recruited in Düsseldorf and Münster.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IVIG treated ? (all criteria a-c must be met):
- •Documented evidence of objective response to IVIG, with clinically meaningful improvement. Clinically meaningful improvement is defined as one of the following: ≥1-point decrease in adjusted INCAT score, ≥4 points increase in I-RODS total score, ≥3 points increase in MRC Sum score, ≥8 kilopascal improvement in mean grip strength (one hand), or an equivalent improvement based on information documented in medical records and per the PI's judgement.
- •Must be on stable IVIG therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or corticosteroids within 8 weeks prior to screening
- •Evidence of clinically meaningful deterioration on interruption or dose reduction of IVIG therapy within 24 months prior to screening, determined by clinical examination or medical records. Clinically meaningful deterioration is defined as one of the following: ≥1-point increase in adjusted INCAT score, decrease in I-RODS total score ≥4 points, decrease in MRC Sum score ≥3, mean grip strength worsening of ≥8 kilopascals (one hand), or an equivalent deterioration based on information from medical records and at the PI's judgement.
排除标准
- •unable to use smartwatch or/and smartphone device
结局指标
主要结局
Longitudinal development of activity parameter: sum of all active time (seconds)
时间窗: 180 days
Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points
Change in Grip strength
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Subjective occurrence of end-of-dose phenomena/wearing off
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Wearing time of smartwatch (daily)
时间窗: 180 days
Longitudinal development of activity parameter: step count
时间窗: 180 days
Change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings
时间窗: 180 days
Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening
Longitudinal development of sleep parameter: number of times user woke up
时间窗: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
时间窗: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
时间窗: 180 days
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
minimum value: 0 points, maximum value: 10 points, best result: 0 points
Change in Medical Research Council (MRC)-Sumscore
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
minimum value: 0 points, maximum value: 60 points, best result: 60 points
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings
时间窗: 180 days
Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football,baseball, or tennis (singles), Playing jump rope
Change in Quality of life (QoL)
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
The Quality of Life Questionnaire (QoL) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas
Questionnaire about smartwatch usage
时间窗: After 6 months (V3)
Longitudinal development of activity parameter: approximate distance traveled (meter)
时间窗: 180 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings
时间窗: 180 days
Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television, Doing the dishes
Longitudinal development of sleep parameter: time to sleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: Withings Sleep score
时间窗: 180 days
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)
Change in Blood analysis (levels of sNfl, serum proteomics)
时间窗: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Longitudinal development of activity parameter: approximate calories burned
时间窗: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
时间窗: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
时间窗: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
时间窗: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
时间窗: 180 days
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)
时间窗: 180 days
Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)
时间窗: 180 days
Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)
时间窗: 180 days
Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)
时间窗: 180 days
Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate.
Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
时间窗: 180 days
次要结局
未报告次要终点
研究者
Dr. med. Marc Günter Pawlitzki
Principal Investigator Marc Pawlitzki, MD
Heinrich-Heine University, Duesseldorf