Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
1 other identifier
interventional
48
1 country
1
Brief Summary
The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior. The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder. Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns. Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group. Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedDecember 16, 2019
December 1, 2019
2.2 years
August 31, 2017
December 13, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Sleep duration
in minutes
6 months
Movement behaviour
evaluated through motion sensors and localization services
6 months
Mood
evaluated by mood surveys
6 months
Communication behaviour
Frequency of usage of communication services
6 months
Secondary Outcomes (1)
Patient acceptance
6 months
Study Arms (2)
People With a Bipolar Affective Disorder
ACTIVE COMPARATORControl subjects without a psychiatric disorder
ACTIVE COMPARATORInterventions
Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
Eligibility Criteria
You may qualify if:
- Written consent of the participant after clarification
- Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group)
- Age between 18 and 70 years
- Knowledge about using a smartphone
You may not qualify if:
- Rejection of participation
- Lack of knowledge about how to deal with a smartphone
- Congenital / early-childhood intelligence reduction
- Moderate / severe dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
Graz, 8010, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 7, 2017
Study Start
September 1, 2017
Primary Completion
November 20, 2019
Study Completion
November 20, 2019
Last Updated
December 16, 2019
Record last verified: 2019-12