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

Primary Purpose

Bipolar Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Smartphone APP
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bipolar Affective Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

People With a Bipolar Affective Disorder

Control subjects without a psychiatric disorder

Arm Description

Outcomes

Primary Outcome Measures

Sleep duration
in minutes
Movement behaviour
evaluated through motion sensors and localization services
Mood
evaluated by mood surveys
Communication behaviour
Frequency of usage of communication services

Secondary Outcome Measures

Patient acceptance
evaluated by a questionnaire

Full Information

First Posted
August 31, 2017
Last Updated
December 13, 2019
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT03275714
Brief Title
Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
Official Title
Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Affective Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
People With a Bipolar Affective Disorder
Arm Type
Active Comparator
Arm Title
Control subjects without a psychiatric disorder
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Smartphone APP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep duration
Description
in minutes
Time Frame
6 months
Title
Movement behaviour
Description
evaluated through motion sensors and localization services
Time Frame
6 months
Title
Mood
Description
evaluated by mood surveys
Time Frame
6 months
Title
Communication behaviour
Description
Frequency of usage of communication services
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient acceptance
Description
evaluated by a questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
City
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

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

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