CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life (CREST)
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
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.
調査の概要
状態
詳細な説明
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).
Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment.
Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I.
All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Nirav Shah, MD, MPH
- 電話番号：6267201547
- メール：nirav@investigator.alethios.com
研究連絡先のバックアップ
- 名前：Zeenia Framroze
- メール：support@alethios.com
研究場所
-
-
California
-
San Francisco、California、アメリカ、94105
- 募集
- Alethios Digital Research Platform (Decentralized)
-
主任研究者：
- Nirav Shah, MD, MPH
-
コンタクト：
- Zeenia Framroze
- メール：support@alethios.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Group A - Neuromodulation Cohort
Participants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program.
Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking.
|
The Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC).
Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home.
The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.
他の名前：
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform.
All participants in both groups receive this program component.
他の名前：
|
|
Group B - Comparison Cohort
Participants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program.
Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement.
|
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform.
All participants in both groups receive this program component.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
時間枠：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.
|
Baseline to Week 12
|
|
EQ-5D-5L Utility Index Score
時間枠：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. |
Baseline to Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
時間枠：Baseline, Week 6, Week 12
|
Within-participant change in PHQ-9 total score.
Range 0-27; higher scores indicate greater depressive symptom severity.
MCID: 5 points.
|
Baseline, Week 6, Week 12
|
|
Generalized Anxiety Disorder-7 (GAD-7)
時間枠：Baseline, Week 6, Week 12
|
Within-participant change in GAD-7 total score.
Range 0-21; higher scores indicate greater anxiety symptom severity.
MCID: 4 points.
|
Baseline, Week 6, Week 12
|
|
Insomnia Severity Index (ISI)
時間枠：Baseline, Week 6, Week 12
|
Within-participant change in ISI total score.
Range 0-28; higher scores indicate greater insomnia severity.
MCID: 6 points.
|
Baseline, Week 6, Week 12
|
|
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
時間枠：Baseline, Week 6, Week 12
|
Within-participant change in WPAI subscale scores for absenteeism (work time missed), presenteeism (impairment while working), and activity impairment (impairment in daily activities).
All subscales scored 0-100%; higher scores indicate greater impairment.
|
Baseline, Week 6, Week 12
|
|
Premenstrual Symptoms Screening Tool (PSST)
時間枠：Baseline to Week 12
|
Within-participant change in PSST total score across 19 symptom items and 5 functional impact items.
Items rated 1-4 (Not at all to Severe); higher scores indicate greater premenstrual symptom burden.
|
Baseline to Week 12
|
|
BrainHQ Cognitive Assessment
時間枠：Baseline to Week 12
|
Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program.
|
Baseline to Week 12
|
|
Healthcare Resource Utilization (HCRU)
時間枠：Baseline to Week 12
|
Within-participant change in self-reported healthcare contacts (ER visits, specialist consultations, primary care visits, prescription medication changes) related to hormonal health symptoms, assessed using a study-specific questionnaire adapted from MEPS items.
|
Baseline to Week 12
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Numerical Rating Scale (NRS)
時間枠：Baseline, Week 6, Week 12
|
Within-participant change in average pelvic or menstrual pain over the past 7 days. Scored 0-10; higher scores indicate greater pain severity. MCID: 2 points. Exploratory outcome. |
Baseline, Week 6, Week 12
|
|
Patient Global Impression of Change (PGIC)
時間枠：Week 12
|
Participant-rated overall impression of change in hormonal health symptoms since study start.
7-point scale from Very much improved (1) to Very much worse (7).
Exploratory.
|
Week 12
|
|
Net Promoter Score (NPS)
時間枠：Week 12, Week 24
|
Participant likelihood to recommend the SGC program.
Scored 0-10.
Exploratory engagement metric for employer-facing reporting.
|
Week 12, Week 24
|
|
Clinical Global Impression of Severity (CGI-S)
時間枠：Baseline
|
Clinician-rated impression of overall symptom severity at onboarding consultation. 7-point scale. Administered by contracted women's health clinician. Exploratory. |
Baseline
|
|
Clinical Global Impression of Improvement (CGI-I)
時間枠：Week 12
|
Clinician-rated impression of overall symptom improvement from baseline to end of program. 7-point scale. Administered by contracted women's health clinician. Exploratory. |
Week 12
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nirav Shah, MD, MPH、Samphire Group, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SAM-003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。