AKTIBIPO-VALIDATION: A Study to Validate Benefits of Mindpax System in Managing Bipolar Disorder

NCT04945057 | Unknown

• 1 other identifier: AKTIBIPO-VALIDATION
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Change in quality of life (Q-LES-Q) at 12 months

  Change from baseline in the Quality of Life Enjoyment and Satisfaction Questionnaire at final visit 12 months from enrolment.

  12 months

Secondary Outcomes (13)

• Change in quality of life (Q-LES-Q) at 6 months

  6 months

• Change in level of disability (WHODAS) at 12 months

  12 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

• Lower number of hospitalization days during first 6 months of followup, compared to a preceding study

  6 months, mirror design

Study Arms (1)

Intervention group

EXPERIMENTAL

All participants will use the Mindpax mobile application, wear the wrist accelerometer and fill in weekly self-assessments. All participants will obtain weekly health tips (general psychoeducation) and additional individualized targeted tips when the system detects deviation from individual mood, activity and sleep patterns. Participants, who did not participate in the previous AKTIBIPO study (DeNovo) will complete additional 3 months of actigraphy and self-evaluation monitoring with research version of the Mindpax application, providing limited feedback and no health tips.

Device: Mindpax monitoring system

Interventions

Mindpax monitoring system DEVICE

All participants will use the Mindpax mobile application, wear the wrist accelerometer and fill in weekly self-assessments. All participants will obtain weekly health tips (general psychoeducation) and additional individualized targeted tips when the system detects deviation from individual mood, activity and sleep patterns, during the active 12 months of followup.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health, Czech Republic: lead
• Mindpax s.r.o., Czech Republic: collaborator

Study Sites (1)

National Institute of Mental Health

Klecany, 250 67, Czechia

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants previously followed in the AKTIBIPO study and newly admitted participants (DeNovo) are included. Participants are followed over 12 months in the programme, collecting primary outcome every 3 months. Some long-term secondary outcomes are compared to values from the equivalent amount of time in the preceding AKTIBIPO study. The newly admitted DeNovo participants are followed for additional 3 months prior to starting the digital programme to collect outcome data from a non-interventional comparison period.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 30, 2021
• Study Start: May 5, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 17, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)