A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
研究概览
简要总结
This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program
- a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.
详细描述
The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed.
All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform.
Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions.
Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules.
Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L).
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-identified female, aged 18-65 years at the time of enrollment
- •Basic English literacy
- •Able and willing to provide informed consent electronically
- •Residing in the United States
- •Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood)
- •Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships
- •Currently in full-time employment with medical benefits as part of compensation package
- •Access to a smartphone with internet access compatible with the Samphire mobile application
- •Able to safely operate the study device in the home environment
- •Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program
排除标准
- •Pregnancy, breastfeeding, or actively planning pregnancy during the study period
- •History of epilepsy or seizure disorder
- •Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation
- •Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use
- •Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use
- •Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening
- •Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening
- •Inability to provide informed consent or safely use the device in the home environment
- •Current participation in another interventional neurotechnology or drug study
结局指标
主要结局
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
时间窗: Baseline to Week 12
Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program. Scores range from 0 to 100%, with higher scores indicating greater impairment. A reduction of 7 percentage points or more is considered clinically meaningful.
EQ-5D-5L Utility Index Score
时间窗: Baseline to Week 12
Within-participant change in EQ-5D-5L utility index score from baseline to end of program. Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, Week 6, Week 12)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline, Week 6, Week 12)
- Insomnia Severity Index (ISI)(Baseline, Week 6, Week 12)
- WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales(Baseline, Week 6, Week 12)
- Premenstrual Symptoms Screening Tool (PSST)(Baseline to Week 12)
- BrainHQ Cognitive Assessment(Baseline to Week 12)
- Healthcare Resource Utilization (HCRU)(Baseline to Week 12)