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

December 13, 2019 updated by: Medical University of Graz

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Graz, Austria, 8010
        • Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

November 20, 2019

Study Completion (Actual)

November 20, 2019

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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