- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275714
Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Graz, Austria, 8010
- Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: People With a Bipolar Affective Disorder
|
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.
|
Active Comparator: Control subjects without a psychiatric disorder
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep duration
Time Frame: 6 months
|
in minutes
|
6 months
|
Movement behaviour
Time Frame: 6 months
|
evaluated through motion sensors and localization services
|
6 months
|
Mood
Time Frame: 6 months
|
evaluated by mood surveys
|
6 months
|
Communication behaviour
Time Frame: 6 months
|
Frequency of usage of communication services
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient acceptance
Time Frame: 6 months
|
evaluated by a questionnaire
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bipolarAPP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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