Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder

Bipolar Affective Disorder Clinical Trial

Official title:

Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275714
• Other study ID #: bipolarAPP
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: November 20, 2019

Study information

• Verified date: December 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Genetic Diseases, X-Linked
• Mood Disorders

Intervention

Device:
• Smartphone APP
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.

Locations

Country	Name	City	State
Austria	Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep duration	in minutes	6 months
Primary	Movement behaviour	evaluated through motion sensors and localization services	6 months
Primary	Mood	evaluated by mood surveys	6 months
Primary	Communication behaviour	Frequency of usage of communication services	6 months
Secondary	Patient acceptance	evaluated by a questionnaire	6 months