Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Reliability of the MyMovesMatter mobile application
研究概览
简要总结
Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands.
Studies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented.
The investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and/or patient selfmanagement.
Digital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment.
Changes in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app.
This will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.
详细描述
This is a prospective multicentre pilot study of the impact of the menstrual/hormonal cycle on PD symptoms and their treatment in pre-menopausal WwPD based on the remote tracking of PD symptoms and menstrual/hormonal cycle through the MMM digital health app in the French language.
There is an ongoing European preliminary study investigating the usability of the MMM App to track menstrual symptoms in WwPD, endorsed by the Parkinson's Disease Research Cluster in the University College Cork in Ireland.
The aim of that study does not overlap with the current proposal.
The aims of the LADY-PD project are:
- Aim 1. To determine the reliability of using our new mobile application to track motor and non-motor symptoms in pre-menopausal WwPD. French WwPD will use the My Moves Matter (MMM) application downloaded in their mobile phone to track their PD symptoms during their hormonal cycle. Changes during the cycle can be identified using a linear system to quantify changes in each symptom. The investigators will measure drop-out rate, missing data, usability, and acceptability (the latter with questionnaires for patients and neurologists).
- Aim 2. To compare the mobile application subjective motor data against the gold standard clinical scale, the motor part of the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). This will be done acquiring data coming from a subset of WwPD who will have an objective measurement of the MDS-UPDRS (using the PDMonitor, a digital device able to measure bradykinesia, tremor, gait, posture, rigidity, dyskinesia) while using the mobile application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-menopausal women
- •Diagnosis of PD according to the MDS criteria onset of PD symptoms since at least two years before inclusion
- •Age 18-56 years
- •On stable medication regimen for PD for at least two months without foreseen need to modify it within the next three months
- •With and without OCP or intrauterine devices (IUD
排除标准
- •Post-menopausal women with PD
- •Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures (i.e., dementia, severe depression, etc.)
- •People not able to give an informed consent.
结局指标
主要结局
Reliability of the MyMovesMatter mobile application
时间窗: Inclusion, 3 months and 6 months
Changes in PD symptoms collected during the menstrual/hormonal cycle versus those collected in the other days of the month. These changes will be evaluated using a linear system included in the My Moves Matter application. In particular, bradykinesia, tremor, gait, posture, dyskinesia, fatigue, anxiety, pain, urinary disturbances and sweating will be assessed.
次要结局
- Subjective versus objective evaluation of Parkinson's disease symptoms(Inclusion, 3 months and 6 months)
- To determine the clinical efficacy of interventions(At 3 months and 6 months)
- To evaluate whether Woman with Parkinson's disease with and without contraception have different clinical outcomes(Inclusion, 3 months and 6 months)
- Usability of the system(At 6 months)