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

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT03275714
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.6
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Affective Disorder	Device: Smartphone APP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Nov 20, 2019
• Actual Study Completion Date: Nov 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: People With a Bipolar Affective Disorder	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.
Active Comparator: Control subjects without a psychiatric disorder	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.

Outcome Measures

Primary Outcome Measures

1. Sleep duration [6 months]

   in minutes

2. Movement behaviour [6 months]

   evaluated through motion sensors and localization services

3. Mood [6 months]

   evaluated by mood surveys

4. Communication behaviour [6 months]

   Frequency of usage of communication services

Secondary Outcome Measures

1. Patient acceptance [6 months]

   evaluated by a questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin	Graz		Austria	8010

Sponsors and Collaborators

• Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT03275714
• Other Study ID Numbers: bipolarAPP
• First Posted: Sep 7, 2017
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Genetic Diseases, X-Linked; Mood Disorders; Bipolar Disorder

Study Results

No Results Posted as of Dec 16, 2019