Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Affective Disorder
- Sponsor
- Medical University of Graz
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Mood
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Rejection of participation
- •Lack of knowledge about how to deal with a smartphone
- •Congenital / early-childhood intelligence reduction
- •Moderate / severe dementia
Outcomes
Primary Outcomes
Mood
Time Frame: 6 months
evaluated by mood surveys
Sleep duration
Time Frame: 6 months
in minutes
Movement behaviour
Time Frame: 6 months
evaluated through motion sensors and localization services
Communication behaviour
Time Frame: 6 months
Frequency of usage of communication services
Secondary Outcomes
- Patient acceptance(6 months)