AKTIBIPO-VALIDATION: A Study to Validate Benefits of Mindpax System in Managing Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in quality of life (Q-LES-Q) at 12 months
研究概览
简要总结
The aim of the AKTIBIPO VALIDATION study is to evaluate the effect of the Mindpax monitoring and microeducation system in patients with bipolar disorder (BD). Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study, as well as new patients (DeNovo) will be enrolled for a follow-up period of 12 months. All participants will wear the wrist actigraphy device and use the Mindpax mobile application on their mobile phone. Through the application, the patients will fill in the weekly mood self assessment questionnaire (ASERT) and receive evidence-based health microeducations aimed at understanding the bipolar disorder and associated risk factors. Apart from general psychoeducation, the participants will receive additional individualized targeted health microeducation when the system detects deviation from individual patterns of mood, activity and sleep. The outcomes will evaluate the subjective and objective impact of system usage on self-reported and clinical outcomes.
详细描述
Study procedure
Up to 130 participants (BD patients) who participated previously in the observational AKTIBIPO study and patients with no history of using the Mindpax system (DeNovo) will be enrolled for a follow-up period of 12 months (+ 3 additional months for DeNovo patients). All participants will wear the wrist actigraphy device (Mindpax) at all times and use the Mindpax mobile application. At enrollment and study completion, the participants will sign the informed consent and undergo evaluation using the MADRS (Montgomery-Asberg depression rating scale) and YMRS (Young mania rating scale) scales.
Collected data
At baseline, i.e. at enrollment to the digital programme (M0) and every three months (M3,M6,M9,M12), the participants will fill in a series of self-assessment questionnaires: the Q-les-Q (the Quality of life Enjoyment and Satisfaction Questionnaire), HLS-CZ-12 (Health literacy survey), WHODAS 2.0 CZ (the WHO disability assessment schedule), BMQ-CZ (Beliefs about medicines questionnaire) and MARS-CZ (the Medication adherence report scale). The patients will also be evaluated using the CGI-S (Clinical global impression, M0-M12). The psychosocial and clinical events (hospitalizations, relapses), current medication and illness history will be collected throughout the study (M0-M12).
The DeNovo patients with no history of using the Mindpax application will complete additional 3 months of actigraphy and self-assessment monitoring with no intervention and limited feedback (mirror period), prior to visit M0. At entering this observational period, the same set of aforementioned instruments will be collected (visit M-3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with a diagnosis of bipolar disorder (BD, F31.x)
- •between 18 to 65 years old.
- •Participants with acceptable compliance in the past AKTIBIPO400 study: completeness of activity data and weekly mood reporting data at least 50% each.
- •Newly admitted patients (DeNovo): currently treated for BD, ability to provide psychiatric hospitalization history provided from medical health record or health insurance records.
排除标准
- •Organic mental disorder
- •mental disorder due to psychoactive substance use,
- •current hospitalization or mood episode at admission, measured by the Montgomery-Åsberg Depression rating scale (MADRS) ≥ 19 or Young Mania Rating Scale (YMRS) ≥ 19 at admission.
结局指标
主要结局
Change in quality of life (Q-LES-Q) at 12 months
时间窗: 12 months
Change from baseline in the Quality of Life Enjoyment and Satisfaction Questionnaire at final visit 12 months from enrolment.
次要结局
- Change in level of disability (WHODAS) at 12 months(12 months)
- Higher rate of health literacy (HLS-12-CZ) at 12 months(12 months)
- Change in quality of life (Q-LES-Q) at 6 months(6 months)
- Higher score of beliefs about medicines questionnaire (BMQ) at 6 months(6 months)
- Change in level of disability (WHODAS) at 6 months(6 months)
- Lower number of hospitalization days during 12 months o of followup, compared to a preceding study(up to 12 months, mirror design)
- Higher value of medication adherence report scale (MARS) at 12 months(12 months)
- Higher value of medication adherence report scale (MARS) at 6 months(6 months)
- Lower number of hospitalization days during first 6 months of followup, compared to a preceding study(6 months, mirror design)
- Lower mean value of the subjectively rated symptom level using the Aktibipo SElf-RaTing (ASERT) questionnaire at 12 months(up to 12 months, mirror design)
- Higher rate of beliefs about medicines questionnaire (BMQ) at 12 months(12 months)
- Lower mean value of the subjectively rated symptom level using the Aktibipo SElf-RaTing (ASERT) questionnaire at 6 months(6 months, mirror design)
- Higher rate of health literacy (HLS-12-CZ) at 6 months(6 months)